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Statistical analyses
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A power analysis was conducted to determine the sample size needed to detect a mean difference of 6 mmol/mol (standard deviation [SD] = 9) in HbA1c. To achieve a power of 80% with a significance level of 0,05 in a two-sided test. It determined that a minimum of 37 participants should be included in each group. Considering potential dropout rates, a total of 100 patients was planned to be enrolled in the study. Participants was randomly assigned to either experimental or control group with a 1:1 distribution as per a computer-generated randomisation.Categorical data are described with frequencies and percentages, n (%), while ordinal, discrete, and continuous data are given as means with accompanying standard deviations (SDs). Tests of differences between baseline and 6-month follow-up within groups were performed using paired t-test for continuous data and the Wilcoxon signed-rank test with continuity correction for ordinal data, whereas tests of differences in changes from baseline to 6-month follow-up between intervention and control groups were performed using the Welch two-sample t-test for continuous data and the Wilcoxon rank-sum test with continuity correction for ordinal data. All statistical analyses were performed in R 4.1.2 (R Foundation for Statistical Computing, Vienna, Austria), with two-sided P-values < 0.05 considered statistically significant.
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Ethics
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Prior to their inclusion in the study, informed consent was obtained from all participants. The study was conducted in accordance with the principles and all the subsequent amendments of the declaration of Helsinki. The Swedish Ethical Review Authority in Uppsala approved this study with diary number 2018–568 and diary number 2019–00133. Additionally, the clinical trial has been registered at ISRCTN under the number 73,435,627; 10.1186/ISRCTN73435627.
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Results
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Baseline characteristics for the intervention and control groups are given in Table
Baseline characteristics of the intervention (n = 35) and control (n = 44) groupsNote: NS, non-significant; SD, standard deviation. Missing value: Glucose monitoring intervention group n = 34, Time in range: intervention group n = 33 and control group n = 43
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Follow-up after 6 months
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SECONDARY
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At the 6-months follow-up, 71 participants remained in the study, with 7 dropping out due to relocation for studies or work elsewhere and 1 for unknown reasons (2 in the intervention-, and 6 in the control group). Among the 33 individuals in the intervention group, 29 participants actively used one or more functions of the application, Table
Different usage of communication path and number of times
Results for primary and secondary outcomes at baseline and 6-months follow-up for individuals with measurements at both time pointsTime in range(%)Time below range(%)Note: Significant P-values are given in
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Glycaemic control
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The baseline HbA1c levels were comparable between the intervention group and the control group, with mean (± SD) values of 63.5 (± 15.0) mmol/mol and 59.6 (± 11.5) mmol/mol, respectively, and no significant differences. The same pattern was observed for the TIR (45.3% vs. 49.7%) and TBR (8.0% vs. 5.7%), again with no significant differences. At the 6-month follow-up, neither between-group nor within-group analyses revealed any significant differences in glycaemic control (HbA1c, TIR, TBR) at the 6-month follow-up. However, there was a numerical improvement by 5% units for TIR in the intervention group (p 0.08, Table
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Perceived hyper- and hypoglycaemia
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hyperglycaemia, hypoglycaemia
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HYPERGLYCAEMIA, HYPOGLYCAEMIA
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At baseline, there were no significant differences between the intervention and control groups in terms of perceived hyperglycaemia (2.8 ± 1.4 vs. 3.4 ± 1.3) or hypoglycaemia (1.6 ± 1.1 vs. 1.8 ± 1.3). After six months, no significant differences were observed within or between the groups for these parameters (Table
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Diabetes treatment satisfaction
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diabetes
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DIABETES
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The study confirmed that there was no significant difference in diabetes treatment satisfaction between the intervention group (29.9 ± 4.1) and the control group (28.8 ± 3.9) at baseline, as measured by the DTSQ. Table
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Quality of life and check your health questionnaire
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The study revealed that the intervention group demonstrated a significant decrease in the physical burden from baseline to 6 months. Thus, in the within-group analysis, the score decreased with 3.23 points, from a mean (± SD) score of 10.5 (± 8.6) points to 7.3 (9.2) points (p = 0.03). Moreover, the change in physical burden from baseline to 6 months differed significantly between the intervention and control groups (p = 0.02), with the score for the control group increasing with 2.62 points, from 8.4 (± 9.2) to 11.1 (± 8.1) points.
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Discussion
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diabetes
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DIABETES, HYPOGLYCAEMIA
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The present study found that the intervention had not significantly improved glycaemic control, perceived hyper- and hypoglycaemia, or diabetes treatment satisfaction compared with the control condition at the 6-month follow-up. In terms of this result, virtual diabetes care is thus neither better nor worse than usual care. Notably, the intervention did have a significant positive effect on the physical burden on quality of life.
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Results in perspective
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PROM, Diabetes, diabetes type 1.Overall, diabetes
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DIABETES TYPE 1, TYPE 1 DIABETES, DIABETES, DIABETES
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The study results are consistent with those of prior research in the area of virtual health interventions for individuals with type 1 diabetes [The present study included 79 participants, 35 in the intervention group and 44 in the control group. There were no significant differences between the two groups in terms of age, diabetes duration, sex, type of therapy or baseline HbA1c levels. At the 6-month follow-up, 71 participants were included. Regarding HbA1c levels and TIR, the participants in present study did not differ significantly from the group of young adults with diabetes type 1 with data in the Swedish National Diabetes Register. However, HbA1c levels were slightly higher among the participants in the present study, compared with data from the Swedish National Diabetes Register (63.5 vs. 59.6 mmol/mol).The findings from this study suggest that while the intervention may not have had a significant impact on traditional diabetes outcomes such as glycaemic control, it did yield a favorable effect on a specific aspect of patient-reported outcome measures (PROM), specifically, the perceived burden of physical health. A potential explanation could be that the person can easily come into contact with the caregiver, which can create a feeling of security, which can lead to the person’s focus and energy being redirected towards other pursuits.This is an important consideration for healthcare providers and policymakers when deciding on interventions for people with diabetes [It is also noteworthy that both the intervention group and the control group perceived a high burden of living with diabetes, indicating that diabetes management is a complex and challenging task. Future research could explore additional interventions or support systems to alleviate the burden of diabetes management and improve quality of life for young people with diabetes type 1.Overall, this study adds to the evidence base on diabetes management interventions and highlights the importance of considering PROMs such as quality of life alongside traditional clinical outcomes. Future research could further explore interventions that target non-traditional outcomes and investigate their long-term effects.
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Strengths and limitations
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diabetes
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HYPOGLYCAEMIA, RECRUITMENT, ADVERSE EFFECTS, HYPERGLYCAEMIA, DIABETES
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In addition to the findings discussed above, this study highlights the challenges of implementing interventions in real-world settings. Originally, our intention was to include 100 participants in the study. However, the widespread development of Covid-19 within society presented obstacles that hindered the recruitment of study subjects. The drop-out rate of 9.6% is not high for a clinical trial but does limit the generalisability of the findings. Furthermore, the study had a relatively short follow-up period of 6 months, and it is possible that longer-term follow-ups would reveal other outcomes.The number of participants was limited, and some outcome differences may have been undetected. There was a skewed distribution in educational level between the randomized groups, and it was significantly lower among those participating in the intervention. Therefore, some positive effects of the intervention could have been underestimated.Like any other questionnaire, the DTSQ has its limitations. One of these limitations is referred to as the ‘ceiling effect’. If a patient’s baseline DTSQ score is high enough, it may be challenging to detect any further improvements in treatment satisfaction following an intervention. Conversely, if the scores for Question 2 (‘hyperglycaemia’) or Question 3 (‘hypoglycaemia’) are low enough at baseline, it may be challenging to detect any decrease after intervention. This is an example of the ‘floor effect’.Due to the vast array of technologies and applications included in digital-based interventions, it is challenging to draw broad conclusions from any single study. Despite numerous investigations into the effectiveness and usability of different tools and approaches, systematic reviews and meta-analyses have been unable to offer conclusive guidance because of variations in study designs, observation periods, study populations and the specific tools/technologies examined.Despite these limitations, this study provides valuable information on the impact of the intervention on quality of life and suggests that interventions targeting non-traditional outcomes may have value. It is also worth noting that the intervention did not have any adverse effects, indicating that it is a safe option for people with diabetes.
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Acknowledgements
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Our deepest gratitude to the patients whose dedication made this study possible. Without their participation, this study would not have been possible.
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Authors’ contributions
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JL, ET, JR, JWE, JF, ALO, AR and EN contributed with: Conception, design, or analysis and interpretation of data. Drafting the article or revising it and providing intellectual content of critical importance to the work described. JL, ET, JF and EN: Responsible for ensuring that issues related to the accuracy of any part of the work were investigated and resolved appropriately. All authors have read and approved the final manuscript.
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Funding
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Diabetes
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DIABETES
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Funding for this study has been provided to J Leksell by the Swedish Diabetes Foundation and The Child Diabetes Foundation, Sweden. The researcher has not received financial support from either commercial entities or non-profit organizations.Open access funding provided by Uppsala University.
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Data Availability
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The datasets generated and/or analysed during the current study are not publicly available due to personal data protection legislation but are available from the corresponding author on reasonable request.
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Declarations
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Ethics approval and consent to participate
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Informed consent was obtained from all participants prior to inclusion in the study. The study was conducted in accordance with the principles and all the subsequent amendments of the declaration of Helsinki. The manuscript does not contain any identifiable information or images. The Swedish Ethical Review Authority in Uppsala has approved this study with diary number 2018–568 and diary number 2019–00133. Further, the clinical trial has been registered at ISRCTN number:73435627; 10.1186/ISRCTN73435627 .
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Consent for publication
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Not Applicable.
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Competing interests
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We confirm that the authors have no competing interests as defined by BMC or any other interests that could potentially influence the results and/or discussion presented in this paper.
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List of abbreviations
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Body mass indexContinuous glucose monitoringContinuous glucose monitoring with intermittent scanning/ flash glucose monitoringContinuous subcutaneous insulin infusionDiabetes Treatment Satisfaction QuestionnaireFlash Glucose MonitoringGlycosylated haemoglobinHealthcare professionalsMultiple daily injectionsPatient-reported outcome measureRandomised controlled trialreal-time Continuous glucose monitoring/ Continuous glucose monitoringStandard deviationTime in rangeTime below range
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References
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1. Introduction
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VLBW, Neurodevelopmental, cognitive and motor function, CF and neurodevelopmental outcomes
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SECONDARY
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Polyunsaturated fatty acids (PUFAs) are vital for brain development, yet limited knowledge exists regarding PUFA intake during complementary feeding (CF) and its impact on neurodevelopmental outcomes in very low birth weight (VLBW) infants. This secondary analysis of a randomized intervention trial, aimed to investigate the association between dietary intake of total PUFAs, arachidonic acid (AA), and docosahexaenoic acid (DHA) during CF and neurodevelopmental outcomes at 12 and 24 months of corrected age (CA). Dietary intakes were assessed using monthly 3 day dietary protocols from 3 to 12 months CA. Neurodevelopmental outcome was evaluated using the Bayley Scales of Infant Development-III. Among the 177 randomized patients, PUFA intake and neurodevelopmental outcomes were evaluated in 140 (79%) infants. Higher total PUFA and DHA intakes significantly correlated with improved cognitive and motor function at 12 months CA, while increased AA intake notably enhanced motor scores at 12 months CA. However, median dietary intakes of AA and DHA (AA: 53.50–84.25 mg/d; DHA: 51.47–76.23 mg/d) fell short of recommended levels (AA: 140 mg/d; DHA: 100 mg/d) at any of the investigated timepoints. These findings emphasize the need to enhance total PUFA, DHA and AA intakes during CF, ensuring adherence to guidelines and unlocking the potential to improve neurodevelopmental outcomes in VLBW infants.Polyunsaturated fatty acids (PUFAs), specifically the Therefore, this secondary analysis of the PIES (Preterm Infants on Early Solid Foods) study aims to investigate the association between PUFA intake during the CF period and neurodevelopmental outcome at 12 and 24 months of corrected age (CA) in VLBW infants. Additionally, this study provides data on current PUFA intakes during the first year CA and whether the recommended dietary guidelines are being met.
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2. Materials and Methods
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2.1. Study Design and Subgroup
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inflammatory bowel syndrome, birth defect, congenital heart disease
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NECROTIZING ENTEROCOLITIS, SHORT BOWEL SYNDROME, SECONDARY, HIRSCHSPRUNG DISEASE, CHROMOSOMAL ABERRATION, DISEASES
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This is a secondary analysis of nutritional data collected during a prospective, randomized, two arm intervention trial and the association with neurodevelopmental outcome in infants born with a birth weight <1500 g. The initial study was designed to investigate the introduction of CF in VLBW infants at two different timepoints. Infants were either introduced to solids between the 10th and 12th week CA (early group) or between the 16th and 18th week CA (late group) and fed a standardized feeding concept throughout the first year CA. Exclusion criteria were any diseases that might affect stable growth (e.g., Hirschsprung disease, inflammatory bowel syndrome, necrotizing enterocolitis with short bowel syndrome, any chromosomal aberration, congenital heart disease, major congenital birth defect). The study was conducted from October 2013 until February 2020 in the outpatient clinic of the Division of Neonatology, Department of Pediatrics, Medical University of Vienna and approved by the ethics committee of the Medical University of Vienna (EK: 1744/2012). The detailed study design was described previously [
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2.2. Standardized Feeding Concept and Dietary Intake Analysis
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Study participants had to follow a standardized feeding concept that was ready-to-use, commercially available baby jar food provided for free by NestleWithin this paper, we analyzed single component dietary intake (DHA, AA) as well as total PUFA intake, defined as all fatty acids with a minimum of 2 double bonds. PUFAs are categorized into 2 main families: omega-3 (
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2.3. Neurodevelopmental Assessment
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Neurodevelopmental
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Neurodevelopmental assessment was conducted using the Bayley Scales of Infant and Toddler Development, third edition (Bayley-III; Harcourt Assessment, San Antonio, TX, USA, 2006) [
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PMC10385005
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2.4. Outcome Parameters
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SECONDARY
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The primary outcome of this study was to assess the effect of dietary mean total PUFA intake during the first year of life on neurodevelopmental outcome (cognition, motor, language) at 12 months CA. One secondary outcome was the association between dietary mean total PUFA intake and cognition, motor and language development at 24 months CA. Another was the association of mean dietary DHA and AA intake during the first year of life and neurodevelopmental outcome at 12 and 24 months of life CA. In addition, we conducted a subgroup analysis to investigate the association of PUFAs with developmental neurological outcomes between sexes, which can be found in the
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2.5. Statistical Analysis
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INTRAVENTRICULAR HEMORRHAGE
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Statistical analysis was performed on the intention-to-treat analysis set (all randomized patients were included), with the exclusion of subjects that were lost for follow-up, moved, no dietary records or withdrawn informed consent. As the number of participants in this analysis was smaller compared to the initial randomized dataset, baseline characteristics and dietary intakes are reported from all participants valid for the analysis of the defined primary outcome, i.e., all subjects in which at least one 3-day dietary record and Bayley-III outcome assessment at 12 months CA was available. In the following, we defined this dataset as “PUFA subgroup”. For ordinal and nominal variables, absolute and relative frequencies are reported and continuous variables are presented using median and interquartile range (IQR). The primary outcome was assessed using linear mixed-effects models with PUFA intake, gestational age at birth, intervention group, sex, highest parental education, nutrition at discharge (breastfed, formula, mixed (breastmilk and formula), and intraventricular hemorrhage (Grades III + IV)) as fixed effects, and a random intercept to adjust for possible correlation between siblings of multiple births. Model estimates and 95% confidence intervals are reported. Secondary outcomes were assessed in the same manner as the primary outcome. As an additional analysis,
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3. Results
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3.1. Screening and Participants
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Out of the 177 patients that were randomized, neurodevelopmental outcome data at 12 months CA and at least one dietary record were available for analysis in 140 patients, accounting for 79% of the total sample size (
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3.2. Baseline Characteristics and Neonatal Morbidity
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Neonatal and obstetric parameters are shown in
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3.3. Dietary Total PUFA, DHA and Intake during the First Year of Life
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SECONDARY
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Although individual mean intakes were considered for primary and secondary outcome analyses, we herein report median dietary intakes and interquartile range across the first year of life of the PUFA subgroup. The median dietary intakes of total PUFAs, DHA and AA throughout the first year of life were 4.55 g/d (IQR: 3.69–5.41 g/d), 60.08 mg/d (IQR: 34.72–85.43 mg/d) and 64.39 mg/d (IQR: 33.45–90.31 mg/d), respectively.
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3.4. Fatty Acid Intake from 3 to 12 Months CA and Comparison with Current Dietary Intake Recommendations
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Median monthly dietary PUFA intake (% of energy) from M3 to M12 is shown in
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3.5. Bayley-III: Cognition, Motor, Language
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Results of Bayley-III assessment are shown in
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3.6. Total PUFA Intake and Neurological Development
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Results of the primary outcome are shown in To evaluate whether the observed relation between total PUFA intake and neurodevelopmental outcome resulted from DHA or AA intake, we further evaluated the association between DHA and AA intake during the first year of life and neurodevelopment at 12 and 24 months CA.
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3.7. DHA Intake and Neurological Development
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Higher dietary DHA intake throughout the first year of life was associated with significantly better cognitive function at 12 months CA (
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3.8. AA Intake and Neurological Development
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Infants who had a higher dietary AA intake throughout the first year of life had significantly better motor scores at 12 months CA (
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4. Discussion
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PMC10385005
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4.1. Dietary Intake of Total PUFAs and Neurodevelopmental Outcome
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VLBW, cognitive and motor scores
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SECONDARY
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This is a secondary outcome analysis of a randomized intervention trial investigating the dietary intake of total PUFAs, DHA and AA during the first year of life and its associations with neurodevelopmental outcome. To the best of our knowledge, there are no published data on dietary intakes of PUFAs during the complementary feeding period and its association with neurodevelopmental outcome in VLBW infants. In this study, we were able to demonstrate that a higher total PUFA intake during the first year of life was significantly associated with better developmental scores, particularly for cognitive and motor scores at 12 months CA. Infants who had higher intakes of total PUFAs also exhibited higher motor and cognition scores at 24 months CA (effect size: 2.74 and 3.37), although the association was not statistically significant. We speculate that the lack of statistical significance may be due to the discontinuation of the standardized feeding concept after the first year of life. Additionally, the subgroup analysis examining the association between PUFA intake and neurodevelopmental outcome across sexes demonstrated that higher intakes of total PUFAs, AA and DHA had a significantly greater positive impact on neurodevelopmental outcomes in male subjects compared to their female counterparts. Therefore, it appears that the intake of PUFAs has sex-specific effects on neurodevelopmental outcomes.Although there are no recommendations on the minimal absolute daily intake, PUFA intake is recommended to be less than 15% of energy for infants up to 24 months of life [
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4.2. Dietary Intakes of DHA and AA and Neurodevelopmental Outcome
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In the present study, we found that higher DHA and AA intakes during the first year of life were significantly associated with better neurodevelopmental outcomes at 12 months CA, but not at 24 months CA. So far, only one study investigated the association between DHA intake during CF and neurodevelopmental outcome; however, that study was in healthy full term infants. In the PINGU (Polyunsaturated fatty acids in child nutrition—a German multimodal optimization study) trial infants received ready-made complementary foods with either ALA-rich rapeseed oil (IG-R), salmon (two times per week) to provide preformed DHA (IG-F) or LA-rich corn oil (control group). Infants in the IG-F group showed enhanced DHA and EPA serum levels [In the present study, median DHA intake was very low and current recommendations (100 mg/d) [
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4.3. Dietary Intakes of LA, ALA and LA/ALA Ratio
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We further conducted a detailed analysis of the dietary LA and ALA intake, as they are essential fatty acids that cannot be synthetized in the human body and must, therefore, be obtained through the diet. Moreover, ALA and AA are precursors for DHA and AA. It is well-established that not only fatty acid quantity, but also the ratio of LA and ALA plays a crucial role in determining the nutritional adequacy of PUFAs [
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4.4. How to Improve Dietary PUFA Intake to Meet a Guideline Diet?
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Breast milk
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Based on the findings of this study, it is desirable to increase the dietary intake of PUFAs in order to meet nutritional requirements and promote better neurological development in VLBW infants during their first year of life. Breast milk is considered the optimal choice for infant feeding and naturally contains both DHA and AA [
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4.5. Study Strength and Limitations
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breast milk
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SECONDARY
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This study has several notable strengths. Firstly, the implementation of a standardized CF concept ensured consistency and accuracy in assessing PUFA intake, which allowed for precise calculations during the CF period. Additionally, the inclusion of monthly dietary records throughout the first year of life provided comprehensive and continuous data on dietary intake. However, it is important to acknowledge the limitations of this study. As a secondary outcome analysis of a randomized controlled trial, the study was not specifically powered to detect statistically significant associations between dietary PUFA intake and neurodevelopmental outcomes. While the study provides valuable insights, studies designed specifically for this purpose would be needed to establish conclusive associations. Furthermore, a limitation of the study was the reliance on mean breast milk intake data from previous studies due to the unavailability of exact intake data. Despite these limitations, this study enhances our comprehension of PUFA intake in VLBW infants and sheds light on the potential impact on neurodevelopmental outcomes.
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5. Conclusions
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The findings of this study demonstrate that higher dietary intakes of total PUFAs, DHA and AA during the first year of life are associated with better neurodevelopmental outcome in terms of motor and cognitive function at 12 months CA. Additionally, the study highlights the need for improvement in dietary DHA and AA intakes during the CF period, as intakes were generally low and did not meet the recommended dietary intake levels. These results emphasize the importance of enhancing total PUFA, DHA and AA intake during CF as valuable goals, not only to comply with dietary guidelines but also to enhance neurological outcomes in very low birth weight (VLBW) infants. By providing evidence on the association between dietary PUFA intake and neurodevelopmental outcomes, this study contributes to our understanding of optimizing post-discharge nutritional management in this vulnerable population.
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Supplementary Materials
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The following supporting information can be downloaded at: Click here for additional data file.
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Author Contributions
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N.H. and B.J., N.H.
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Conceptualization, N.H.; Methodology, N.H., M.T. and M.G.; Formal Analysis, M.G. and F.E.; Investigation, M.G. and M.T.; Resources, N.H., B.J. and A.B.; Data Curation, M.G., M.T., R.F. and S.B.; Writing—Original Draft Preparation, M.G.; Writing—Review and Editing, N.H., M.T., B.J., F.E., R.R. and R.F.; Visualization, M.G. and F.E.; Supervision, N.H. and B.J.; Project Administration, N.H.; Funding Acquisition, N.H. All authors have read and agreed to the published version of the manuscript.
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Institutional Review Board Statement
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The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Ethics Committee of the Medical University of Vienna (EK:1744/2012, date of approval: 10 January 2013) and registered on
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Informed Consent Statement
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Written informed consent was obtained from at least one parent.
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Data Availability Statement
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The study protocol and the individual participant data that underlie the results reported in this article, after de-identification, are available upon request from the corresponding author 6 months after publication. Researchers will need to state the aims of any analyses and provide a methodologically sound proposal. Proposals should be directed to
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Conflicts of Interest
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Nadja Haiden reports consulting fees from Medis, MAM, Baxter and Nestle and honoraria for lectures from Nestle, Baxter, Danone and Hipp outside the submitted work.
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References
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intraventricular hemorrhage, Bell’s stage ≥ Ila) or after exploratory surgery, Dietary fatty acid
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NECROTIZING ENTEROCOLITIS, INTRAVENTRICULAR HEMORRHAGE, SECONDARY, PERIVENTRICULAR LEUKOMALACIA, REGRESSION, RETINOPATHY OF PREMATURITY
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Flow chart of study profile.Dietary fatty acid intake from 3 to 12 months of life CA in comparison with dietary intake recommendations. (Bayley-III composite scores at 12 and 24 months corrected for term.Main fatty acids of the Baseline characteristics of the PUFA subgroup—obstetric parameters and neonatal outcome.Categorical data are presented as numbers with percentages in parentheses. Continuous data are presented as median with interquartile range in parentheses. Parental education data were collected at study inclusion and divided into three groups according to highest education of either parent: primary education = compulsory school; secondary education = high school; tertiary education = postsecondary education. Necrotizing enterocolitis was diagnosed either clinically (Bell’s stage ≥ Ila) or after exploratory surgery. Cerebral ultrasound was used for the diagnosis of intraventricular hemorrhage and periventricular leukomalacia. Retinopathy of prematurity was diagnosed by direct ophthalmoscopy.Dietary total PUFA intake during complementary feeding and its association with neurodevelopmental outcome at 12 and 24 months CA.PUFA, polyunsaturated fatty acids; CA, corrected age; CI, confidence interval; ERS, estimated regression slope (increase in cognition/language/motor score per g PUFA/d). Dietary DHA intake during complementary feeding and its association with neurodevelopmental outcome at 12 and 24 months CA.DHA, docosahexaenoic acid; CA, corrected age; CI, confidence interval; ERS, estimated regression slope (increase in cognition/language/motor score per mg DHA/d). Dietary AA intake during complementary feeding and its association with neurodevelopmental outcome at 12 and 24 months CA.AA, arachidonic acid; CA, corrected age; CI, confidence interval; ERS, estimated regression slope (increase in cognition/language/motor score per mg AA/d).
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PMC10385005
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Methods
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Three hundred and eleven adults (median age of 44 years, IQR 34–54 years) were randomly assigned to a salt reduction (
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PMC10679749
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Results
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−2.6, hypertension, −3.8, DBP [mean change of −1.5 mm Hg
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SECONDARY, HYPERTENSION
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There were no significant differences in primary and secondary outcomes between the two program groups. When comparing each program to baseline, the program focused on salt reduction was effective in lowering BP following a 12-week intervention with a mean change of −2.5 mm Hg in SBP (95% CI, −4.1 to −0.8) and − 2.7 mm Hg in DBP (95% CI, −3.8 to −1.5) in the intention-to-treat (ITT) analysis. In the complete-case (CC) analysis, the mean change was −2.1 mm Hg in SBP (95% CI, −3.7 to −0.5) and − 2.3 mm Hg in DBP (95% CI, −3.4 to −1.1). This effect increases in subjects with high-normal BP or hypertension [SBP − 7.9 mm Hg (95% CI, −12.5 to −3.3); DBP − 7.3 mm Hg (95% CI, −10.2 to −4.4)]. The healthy lifestyle group also exhibited BP improvements after 12 weeks; however, the changes were less pronounced compared to the salt reduction group and were observed only for DBP [mean change of −1.5 mm Hg (95% CI, −2.6 to −0.4) in ITT analysis and − 1.4 mm Hg (95% CI, −2.4 to −0.3) in CC analysis, relative to baseline]. Overall, improvements in Na
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Conclusion
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HYPERTENSION
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Salt-focused programs are effective public health tools mainly in managing individuals at high risk of hypertension. Nevertheless, in general, empowerment-based approaches are important strategies for lowering BP, by promoting health literacy that culminates in adherence to the Mediterranean diet and weight reduction.
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PMC10679749
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Introduction
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Hypertension, CVD
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CARDIOVASCULAR DISEASES, CVD, HYPERTENSION, HYPERTENSION, HIGH BLOOD PRESSURE
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Changing unhealthy lifestyle behaviors can decrease the prevalence of individuals with high blood pressure (BP) and cardiovascular diseases (CVD), contributing greatly to the sustainability of healthcare systems worldwide (Several dietary approaches have been proposed to reduce BP, including the Dietary Approaches to Stop Hypertension (DASH), the low-salt diet, and the Mediterranean diet (However, in the context of preventing and treating hypertension, dietary interventions are mostly assessed individually. Yet, recent systematic reviews exploring both the DASH and Mediterranean diets have revealed that the DASH diet shows the most convincing proof of its efficacy in lowering BP (Furthermore, some of these studies use controlled and specific feeding methods to make sure participants stick to the planned diets. This is verified through close monitoring of participants during on-site meals, along with inquiries about their consumption of study foods, and the collection of urine samples. Although it is important to acknowledge that while these controlled scenarios play a critical role in assessing efficacy, they may not precisely mirror how these findings would apply to the daily circumstances of the broader population.In the realm of encouraging changes in behavior, empowerment-based methods have emerged as powerful triggers, giving citizens the freedom to steer their own choices toward healthier eating preferences (Hence, the driver to improve public health centers on spreading health information grounded in evidence, raising awareness, and empowering people to integrate personalized and suitable health-conscious behaviors into their daily routines.With this viewpoint in mind, we designed a randomized comparative trial to thoroughly examine the effectiveness of two empowerment-driven approaches. One of these strategies focused on reducing salt intake, echoing the principles of the DASH diet, while the other centered around fostering a holistic and all-encompassing healthy lifestyle regimen. This latter approach incorporated guidance aligned with the core principles of the Mediterranean dietary pattern.These educational efforts were carefully designed to enhance participants’ understanding of beneficial lifestyle practices. Moreover, the programs provided participants with practical resources to help them adopt new habits. This comprehensive toolkit encompassed strategies for embracing wholesome cooking practices and making well-informed choices when buying food. Essentially, our main goal was to determine which of these empowerment-focused methods would prove to be the more effective driver in nurturing health-oriented dietary habits and achieving reductions in BP across the broader population.
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PMC10679749
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Materials and methods
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PMC10679749
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Study design
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This study is a multicenter, randomized, comparative effectiveness trial comparing the outcomes of two different 12-week empowerment-based approaches to promote healthy habits in the general population. The trial was conducted between March 2019 (the first candidate screened for eligibility) and September 2019 (the end of the 12-week follow-up of the last participant), after obtaining approval from the Ethical Committee of the Hospital CUF on December 18, 2018, for the project. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki and followed the Good Clinical Practice guidelines. All enrolled participants provided voluntary, written informed consent. The present study adhered to the CONSORT reporting guidelines (
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PMC10679749
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Participants
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peripheral arteriosclerosis, cancer, liver or kidney diseases, ischemic cardiovascular disease, substance abuse
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MYOCARDIAL INFARCTION, STROKE, CARDIOVASCULAR DISEASE, CANCER, UNSTABLE ANGINA, PERIPHERAL ARTERIOSCLEROSIS, HYPERTENSION
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The study enrolled adult participants aged 20 to 70, who were responsible for acquiring and preparing their own meals, normal or with hypertension. Medicated hypertense individuals were included if medication and diet was stable for at least 3 weeks before the study. Eligible participants had to be willing and able to comply with the study protocol and provide informed consent. Exclusion criteria included a history of cardiovascular disease (such as ischemic cardiovascular disease, stable or unstable angina, myocardial infarction, stroke, or symptomatic peripheral arteriosclerosis), liver or kidney diseases, or cancer. Participants were also excluded if they were pregnant or breastfeeding women, women planning to become pregnant within the study period, had a history of drug, alcohol, or other substance abuse, or had other factors that might limit their ability to cooperate during the study.
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PMC10679749
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Recruitment
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RECRUITMENT
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Participants were recruited from the Lisbon Metropolitan Area through public advertisements in online newspapers and social media. Participants underwent eligibility screening and assessment at the study centers, which included the Hospital CUF Descobertas and Hospital CUF Infante Santo. Eligible participants were randomly assigned to one of two intervention groups (in a 1:1 ratio) using a computer-generated allocation sequence. The allocation was concealed through sequentially numbered, opaque, sealed envelopes. The allocation sequence was generated by a statistician who was not involved in recruitment or intervention delivery, ensuring that the allocation process was objective and unbiased. To maintain participant masking, the interventions were administered on different schedules, and participants were kept unaware of their assigned interventions.
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PMC10679749
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Interventions
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PMC10679749
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Salt-reduction program
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Participants randomized to the salt reduction program received a multi-component educational program for 12 weeks, consisting of three educational sessions that occurred during clinic visits (baseline, 4-week, and 8-week), five individual practical training sessions at the local supermarket, and 8 telephone counseling calls. During the initial educational session, participants received information regarding salt consumption, the health implications of excessive salt intake, and the foods they should avoid to reduce their salt intake. In the subsequent session, participants were educated on how to decipher food labels, make choices that have lower salt content within the same food group, and understand the significance of substituting salt with herbs and spices. In the final session, participants were enlightened about interpreting salt-related nutritional claims and the importance of meeting recommended fruit and vegetable intake. Additionally, the impact of potassium, calcium, and magnesium on BP was discussed, along with the identification of optimal dietary sources for these minerals. Following each session, participants were provided with an informational flyer covering the discussed topics. Participants in the salt reduction group benefitted from practical educational sessions conducted within supermarkets, facilitating the application of the acquired knowledge during the purchasing process. To further solidify the information transmitted during in-person education, telephone counseling calls were implemented between sessions.
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PMC10679749
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Healthy lifestyle program
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Participants randomized to the healthy lifestyle program received a 12-week educational program that consisted of three sessions during clinic visits (at baseline, 4-weeks, and 8-weeks) and 12 telephone counseling calls. The first session focused on the impact of the Mediterranean diet on health, with an emphasis on cardiovascular health. It included recommendations on the best food choices and foods to avoid as part of the principles of the Mediterranean food pattern. The second session addressed various lifestyle topics, such as the importance of hydration, how to increase water intake, physical activity, and sleep quality. The third session focused on the negative health impact of addictive habits, such as alcohol consumption and smoking, as well as healthy culinary methods. After each session, participants received a flyer summarizing the topics discussed. Furthermore, they received four telephone counseling calls after each face-to-face session to reinforce the information and clarify any questions or doubts.
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PMC10679749
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Outcome assessment
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We collected 24-h urine samples at baseline and after the 12-week intervention period to estimate NaFlow diagram portraying the study design.
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PMC10679749
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Statistical analysis
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The sample size calculation was based on the estimated difference in salt reduction between the two groups after 12 weeks. Assuming a salt reduction of 1 g/day and a standard deviation of 3.8 g/day (Descriptive statistics were reported as numbers and percentages for categorical variables and as mean and standard deviation for continuous variables, or median and interquartile ranges if the variable’s distribution was skewed. Between-group differences at baseline were assessed using appropriate tests such as the independent sample t-test, Mann–Whitney U test, or chi-squared test.The effect of the intervention on changes in BP, 24-h urinary excretion of Na
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PMC10679749
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Results
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PMC10679749
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Recruitment and baseline characteristics of the participants
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overweight, CVD, dyslipidemia
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OBESE, CARDIOVASCULAR DISEASES, CVD, RECRUITMENT, SECONDARY, HYPERTENSION, DYSLIPIDEMIA
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From March 29 to June 4, 2019, a total of 352 candidates were screened for eligibility. After an initial assessment, 30 declined to participate and 11 did not meet the inclusion criteria. Thus, 311 participants were enrolled, comprising 224 women and 87 men with a median age of 44 years (IQR 34–54 years), who were randomly assigned to either a salt reduction-focused program (The study ended before the estimated 500 participants were recruited due to lower than anticipated recruitment rates. All participants contributed to baseline data and their characteristics are shown in Baseline demographic and clinical characteristics of participants by randomized group.Data are number of participants (%), mean (standard deviation), and median (interquartile range). CVD, cardiovascular diseases; BMI, body mass index; BP, blood pressure. p values were calculated using independent samples t test, Mann–Whitney U test or chi-squared test as appropriate.Most participants were white Europeans (92.6%), professionally active (81.0%), and had a university degree (74.9%). Additionally, over half were overweight or obese (61.4%) and had an average adherence to a Mediterranean diet (67.2%) at baseline. Two-thirds of the participants had a family history of hypertension, dyslipidemia, or CVD (66.9%), while almost one-fourth had dyslipidemia (26.0%). At study entry, 17.0% of participants reported having hypertension, and 22.5% were taking antihypertensive medication. At baseline, the mean systolic/diastolic BP was 116/76 (SD 15/10) mmHg, and the estimated mean 24-h urinary NaThe study’s primary and secondary outcome measures are presented in Mean difference in outcome measures after 12 weeks.Values are mean (95% CI). ANCOVA models were adjusted for study center, age, sex, antihypertensive medications, baseline systolic blood pressure value, participant program protocol compliance and smoking status. *After the 12-week intervention, there were no significant differences observed between the salt reduction-focused and healthy lifestyle programs regarding predicted 24-h urinary NaThe reduction in BP within the groups may be attributed to the enhancement in predicted 24-h K
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PMC10679749
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Impact of intervention on blood pressure
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hypertension
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HYPERTENSION
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After 4 weeks, both the salt reduction and healthy lifestyle programs led to lower SBP compared to baseline: −1.7 mm Hg (95% CI, −3.1 to −0.3) for the salt reduction and − 1.5 mm Hg (95% CI, −2.8 to −0.2) for the healthy lifestyle. Importantly, the salt reduction group maintained lower SBP at 8 and 12 weeks, unlike the healthy lifestyle group (Change in office blood pressure (BP) from baseline to 4, 8 and 12 weeks in the complete-case population. All participants from salt reduction and healthy lifestyle groups were included in the analysis of systolic BP In participants with high-normal or hypertension (SBP ≥ 130 and/or DBP ≥ 85, mm Hg;
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PMC10679749
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Impact of Na
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Participants were categorized into quintile groups (Q1 to Q5) based on changes in the 12-week NaChange in office blood pressure (BP) stratified by mean quintiles of changes in NaWhile not reaching statistical significance, these findings suggest that a lower Na
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Impact of weight and adherence to the mediterranean diet on blood pressure
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For each program, participants were divided into Q1 to Q5 quintile groups based on weight changes after 12 weeks compared to baseline (lowest to highest change). We then analyzed how changes in SBP and DBP related to these weight quintile groups (shown in Change in office blood pressure (BP) stratified by mean quintiles of changes in weight Adherence to the Mediterranean diet was assessed using a well-established 14-item questionnaire known as the Mediterranean Diet Adherence Screener (MEDAS). Based on MEDAS scores, there was a noteworthy increase in mean adherence to the Mediterranean diet within both groups after the 12-week period: 0.9 (0.6 to 1.2, Subsequently, participants were categorized into quintile groups based on the extent of their changes in adherence to the Mediterranean diet following the 12-week follow-up in comparison to their baseline measurements (Furthermore, an investigation was undertaken to explore the relationship between Na+/K+ ratios and enhanced adherence to the Mediterranean diet (
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PMC10679749
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Discussion
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weight reduction, intentional behavior, BP decrease, hypertension, weight loss
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CVD, MINOR, HYPERTENSION
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In the broader effort to address the impact of high BP and CVD across populations, there is a pressing need to establish effective strategies for encouraging behavior changes (Our findings revealed that both interventions were effective in reducing DBP after 12 weeks. However, only the intervention focused on salt reduction was significantly effective in decreasing SBP, with a substantial mean reduction of −2.5 mm Hg after 12 weeks compared to baseline. Furthermore, the salt reduction program was more effective at reducing BP in participants with high-normal or hypertension at baseline (SBP ≥ 130 and/or DBP ≥ 85, mm Hg; Schematic representation of the clinical trial design, showing the major characteristics of the intervention groups. The outcome variables are highlighted as well as the major findings.The magnitude of our results in a short period is outstanding and consolidates the importance of diet and nutrition in the management of hypertension, independently of pharmacology. Because BP decrease is semilogarithmic associated with the incidence of cardiovascular outcomes, even a minor reduction has significant benefits (Nevertheless, it was somewhat surprising that the interventions yielded no significant impact on NaIndeed, the observed decrease in BP in our study can be attributed to the intentional behavior changes adopted by participants over the 12-week intervention period. Specifically, participants increased their consumption of vegetables, fruits, fish, tree nuts and dishes seasoned with sofrito, while reducing their intake of processed meats, butter, margarine, and high-sugar products. Significantly, these dietary changes comprise beneficial food ingredients that could account for the observed decrease in BP. Notably, the presence of vitamins and flavonoids in vegetables and fruits might induce blood vessel relaxation, driven by their antioxidant and anti-inflammatory properties (Furthermore, these dietary modifications yielded improvements in various anthropometric measures, ultimately contributing to the reduction in BP. While variations in body measurements did not result in a significant mean difference, a noticeable trend toward weight reduction was apparent. It is worth noting that weight loss constitutes a significant lifestyle factor in the prevention and management of hypertension, often influenced by dietary choices and physical activity (As expected, participants who achieved the largest reductions in NaAccording to current hypertension prevention guidelines, lifestyle changes such as a healthy diet are recommended for all patients as they can delay or complement ongoing treatment (The strengths of our study include a randomized design and a notably ample sample size. We employed an interdisciplinary empowerment-based approach by collaborating with a multidisciplinary team of 12 nutritionists operating within clinical and grocery shopping settings. Furthermore, we adopted a pragmatic approach, involving participants with hypertension and those using antihypertensive medications. Through this deliberate inclusion of individuals from this high-risk group, the applicability of the study findings to a broader population is enhanced, thereby increasing the generalizability of our findings. Lastly, we followed a standardized protocol and strict quality control procedures for clinical measurements and data collection, thus ensuring the accuracy and consistency of our data.On the other hand, this trial presents several limitations that warrant acknowledgment. Firstly, differences in group retention were noted, with a lower attrition rate observed among participants in the salt reduction program compared to the holistic healthy lifestyle group. This divergence could be attributed to the comparatively reduced contact inherent to the healthy lifestyle program, potentially leading to a diminished level of motivation among these participants. This variance in follow-up could potentially introduce bias favoring the salt reduction group. However, intention-to-treat analyses employing multiple imputation methods, to address missing data, yielded outcomes consistent with the complete-case analysis. Secondly, there was an imbalance in the sex distribution, with a higher proportion of women in the healthy lifestyle group. Nonetheless, we addressed this disparity by incorporating sex and participant compliance as covariates in the analysis to mitigate potential confounding effects. Thirdly, the study concluded before attaining the intended sample size of 500 participants. Although the study still encompassed a relatively substantial sample size, the failure to reach the target number might have impacted the statistical power to discern differences in outcome assessments between the groups. Fourth, due to ethical considerations, the study lacked a no-intervention control group, and the design did not allow double-blinding. Fifth, it is worth noting that participants who volunteer for dietary trials generally exhibit a higher degree of motivation to adhere to a dietary program compared to the broader population. Furthermore, most participants were professionally active and had higher levels of education, potentially facilitating a greater assimilation of knowledge. Consequently, the outcomes of the programs may not be as effective in the general population.
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PMC10679749
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Conclusion
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weight loss, hypertensive
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This study shows that empowerment-based approaches, aimed at promoting healthy culinary habits and improved purchasing options, effectively lower BP in the short term. However, an intervention focused on educating participants about salt reduction was found to be more impactful in lowering both systolic and diastolic BP, particularly in those with high-normal or hypertensive BP. Moreover, approaches that promote adherence to the Mediterranean diet were associated with weight loss and a decrease in the Na
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PMC10679749
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Data availability statement
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The original contributions presented in the study are included in the article/
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Ethics statement
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The studies involving humans were approved by Ethical Committee of the Hospital CUF. The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study.
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PMC10679749
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Author contributions
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JP, CMO, MPS, CM
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AM-R: Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Supervision, Validation, Visualization, Writing – original draft. SI: Data curation, Investigation, Writing – review & editing. IB-M: Data curation, Investigation, Writing – review & editing. JM: Data curation, Investigation, Writing – review & editing. CR: Data curation, Investigation, Writing – review & editing. IC: Data curation, Investigation, Writing – review & editing. IM: Data curation, Writing – review & editing. MIS: Data curation, Writing – review & editing. LC: Data curation, Writing – review & editing. CBO: Data curation, Writing – review & editing. TH: Data curation, Writing – review & editing. PP: Data curation, Writing – review & editing. DÉP: Data curation, Writing – review & editing. CMO: Data curation, Writing – review & editing. JM: Data curation, Writing – review & editing. TS: Data curation, Writing – review & editing. JA: Writing – review & editing. JR: Writing – review & editing. DIP: Writing – review & editing. MPS: Writing – review & editing. CM: Writing – review & editing. AF: Writing – review & editing. JP: Conceptualization, Formal analysis, Investigation, Supervision, Validation, Visualization, Writing – review & editing. CC: Conceptualization, Formal analysis, Funding acquisition, Investigation, Supervision, Validation, Visualization, Writing – review & editing.We are grateful to the facilitators, clinicians, researchers, and administrators at Hospital CUF Descobertas, Hospital CUF Infante Santo, and CUF Academic and Research Medical Center for their invaluable contributions to this study. We also thank the team at Pingo Doce for their collaboration in implementing the in-store component and Centro de Medicina Laboratorial Germano de Sousa for their support in sample processing and analysis. Finally, we extend our appreciation to all study participants for their enthusiastic collaboration and dedication to this research.
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PMC10679749
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Conflict of interest
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The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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Publisher’s note
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All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
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Supplementary material
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The Supplementary material for this article can be found online at: Click here for additional data file.
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PMC10679749
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References
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PMC10679749
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Supplementary Information
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ideation
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Despite suicide ideation being one of the most frequently reported health issues impacting tertiary students, there is a paucity of research evaluating the efficacy of preventive interventions aimed at improving mental health outcomes for students studying at two tertiary institutes. The current study evaluated the efficacy of the “Talk-to-Me” Mass Open Online Course (MOOC) in improving tertiary students’ abilities to support the mental health of themselves and their peers via a randomised controlled trial design, comparing them to a waitlist control group. Overall, 129 tertiary students (The online version contains supplementary material available at 10.1007/s00787-022-02094-4.
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PMC9531217
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Keywords
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Open Access funding enabled and organized by CAUL and its Member Institutions
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PMC9531217
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Introduction
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deaths, death, ’ mental distress
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Young adulthood represents a period of necessary personal growth and development, moving towards mastering the increased demands of adulthood and developing a personal identity [In 2019, a total of 1,609,798 students were studying at the tertiary level in Australia [Suicide is a leading cause of death among young adults, accounting for an estimated 700,000 deaths globally each year [Recently, a literature review exploring Suicide prevention programs targeting tertiary students [The “Talk-to-Me” program is a Suicide prevention program originating in Germany that aims to teach students to identify and respond to suicidal crises and suicidal thoughts and behaviours. The program has recently been adapted for an Australian context, delivered online as a Massive Open Online Course (MOOC), a course of study made freely available over the internet to a very large number of people. The MOOC consists of six modules: (1) Mental fitness; (2) Strategies to increase mental fitness; (3) Self-injury; (4) Suicidal behaviour in young adults; (5) Interventions for suicidal behaviour; and (6) Gatekeeper interventions. The “Talk-to-Me” MOOC aims to raise awareness of mental health-promoting activities, build resilience, and equip students with practical skills to deal with their own and others’ mental distress. The online delivery format alleviates some of the barriers (e.g., lack of time and financial security) [
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PMC9531217
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Methods
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PMC9531217
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Design
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Following a pre-defined protocol [
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PMC9531217
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Participants
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anxiety
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Participants were recruited via flyers sent through the university learning management systems of two universities in Perth, Western Australia (Curtin University and the University of Western Australia) from February to March 2020. Full or part-time students enrolled in health or education degrees from these universities enrolled in a second or third-year undergraduate or Graduate Entry Master's level were eligible to participate in the study. First and fourth-year undergraduate students were not invited due to the potential peak of study-related anxiety or stress levels [
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PMC9531217
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Intervention
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“Talk-to-Me” is an online psychoeducational Suicide prevention program targeting young adults [
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PMC9531217
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Procedures
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Prior to group allocation, a survey link to Qualtrics [
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PMC9531217
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Statistical analysis
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A data frame with 300 participants allocated to intervention and control groups and assessed at three assessment time points was created using RStudio Version 4.2.1 [
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PMC9531217
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Results
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PMC9531217
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Primary and secondary outcomes
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REGRESSION, SECONDARY
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Findings did not demonstrate any significant difference in SIRI-2 scores between ESG and DSG before crossover was applied (Similar to SIRI, no significant difference was observed in any of the secondary outcomes between ESG and DSG before or after the crossover of The effects of time by group (ESG/DSG) on the study’s outcome measures. The graphs display the time (T0/T1/T2) by group (ESG/DSG) interaction on the study’s outcome measures, using the random-effects regression model. Errors bars are reported at a 95% confidence interval. Despite the medium and large attrition rates at the end of periods 1 (28%) and 2 (40%), there was no difference between the effect sizes resulting from the ITT approach on any of the outcome measures (primary or secondary) compared to those of the mixed model analysis without any ad-hoc imputation (per-protocol analysis).
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PMC9531217
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Acceptability of “Talk-to-Me” MOOC
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Overall, 74 participants from both the ESG and DSG provided insight into how they perceived the program. Findings suggested a high satisfaction with the content and delivery of the “Talk to Me” MOOC [Median = 43.5,
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PMC9531217
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Discussion
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generalised
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ADVERSE EVENTS, SECONDARY
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This pragmatic crossover RCT evaluated the efficacy of an online psychoeducational Suicide prevention program, “Talk to Me”, firstly in improving university students’ ability to identify and respond to suicidal statements; and, secondly, in improving participants’ knowledge of the program’s content, their ability to recover from stress and adverse events, academic stress, global distress, generalised self-efficacy, and attitudes towards help-seeking behaviour when experiencing mental health issues. Despite the lack of significance for the “Talk to Me” MOOC compared to treatment as usual, in improving the primary and secondary outcomes of this study, students expressed high satisfaction with the program. Although the reason for these contradictory findings is unknown, it highlights the benefits of capturing the student’s views about the program along with the outcome measures [Notably, the feasibility and robustness of the outcome framework utilised to measure the efficacy of the MOOC were not assessed prior to the RCT [As discussed in the protocol of the present study [Accurately measuring university students’ situational responses to suicidal crises is challenging [Overall, all of the participants who participated in the post-program survey (60%) reported high levels of satisfaction with the “Talk to Me” MOOC content, generally finding the content easy to learn and engaging. It is important that online programs targeting university students are contemporary and enable an emotional connection with participants. A recent systematic review identified intervention-specific and person-specific factors that influence the usage of digital mental health interventions that should be considered. These factors include the medium of delivery mode, language used and helpfulness of the overall program [Students identified strongly with content relating to mental fitness. Mental fitness is a state of psychological well-being derived from one’s thoughts and emotions and is based on the need for relatedness, competency and autonomy support [Finally, the online delivery of the program provided students with the opportunity to access the material in their own time [
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PMC9531217
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Limitations and areas for further research
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The findings of the current study should be viewed as preliminary in the context of its limitations. This study employed a rigorous crossover design approach to explore the superiority of “Talk to Me” to treatment as usual. However, data collected at the end of Period 1 was used to assess change over the second period, with the carry effects from the first period remaining unknown. Also, as the current study did not collect information about other support or medications the students may have received during their enrollment or employ a methodology enabling daily sampling of students’ mental health during the study period, the effect of other factors influencing the study outcomes remains unknown.Given the nature and sensitivity of the topic covered in the “Talk-to-Me” MOOC, and according to the ethics recommendations, the researchers were allowed to recruit participants only within their schools, restricting findings to two faculties from two universities situated in Western Australia. Although this limitation provided an opportunity to pilot the program with students whose interests and professional goals aligned with the MOOC, future research may benefit from further exploration of how all university students across Australia may benefit from the “Talk-to-Me” MOOC.Further, between screening and commencement of the MOOC, participants were required to create a user profile on the edX platform, which may account for the number of dropouts between screening and intervention commencement [
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PMC9531217
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Conclusions
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This study indicated that receiving the online “Talk to Me” MOOC it is not enough to enable students to develop skills to respond to others in distress. Future suicide prevention interventions among tertiary students may consider using online peer mentoring programs to create user groups where participants can practice their skills face-to-face. Further research with a large national sample of university students is also warranted to determine the robustness of the current findings.
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PMC9531217
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Supplementary Information
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Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 16 KB)Supplementary file2 (DOCX 18 KB)Supplementary file3 (DOCX 21 KB)Supplementary file4 (DOCX 20 KB)Supplementary file5 (DOCX 27 KB)Dr Afsharnejad and Dr Milbourn contributed equally as first authors to this paper.
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PMC9531217
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Acknowledgements
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We acknowledge the generous support from Nicole David, Patricia Tran and Paulene Tavani who assisted with the delivery of the “TALK-to-Me” MOOC. We would also like to thank all the students who took part in this study.
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PMC9531217
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Author contributions
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MHE
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All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by BM, EB-Y, BA, MH-E. The first draft of the manuscript was written by BA, MHE, BM and SG. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
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PMC9531217
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Funding
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Deutscher Akademischer, Milbourn
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Open Access funding enabled and organized by CAUL and its Member Institutions. The authors would like to acknowledge the following fundings, making this study possible. Dr Black, Dr Thompson, Dr Kacic, Mr Zimmermann, Professor Girdler, and Dr Milbourn received funding from Healthway (Grant 33212). Dr Milbourn and Professor Girdler received funding from the Australian New Zealand Allied Health Professional Educator organisation (ANZAHPE;) and The German Academic Exchange Service (Deutscher Akademischer Austauschdienst, DAAD; Grant 57511161). The views of the funders have not influenced the content of this paper.
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PMC9531217
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Availability of data and material
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There is no public access to the datasets generated and/or analysed during the current study, and they are only available from the corresponding author upon reasonable request.
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Code availability
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Not applicable.
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PMC9531217
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Declarations
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PMC9531217
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