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Analysis of the psychological impact of a vascular risk factor intervention: results from a cluster randomized controlled trial in Australian general practice
Clinical presentation, diagnosis, and management
Screening for vascular disease, risk assessment and management are encouraged in general practice however there is limited evidence about the emotional impact on patients. The Health Improvement and Prevention Study evaluated the impact of a general practice-based vascular risk factor intervention on behavioural and physiological risk factors in 30 Australian practices. The primary aim of this analysis is to investigate the psychological impact of participating in the intervention arm of the trial. The secondary aim is to identify the mediating effects of changes in behavioural risk factors or BMI.
This study is an analysis of a secondary outcome from a cluster randomized controlled trial. Patients, aged 40–65 years, were randomly selected from practice records. Those with pre-existing cardiovascular disease were excluded. Socio-demographic details, behavioural risk factors and psychological distress were measured at baseline and 12 months. The Kessler Psychological Distress Score (K10) was the outcome measure for multi-level, multivariable analysis and a product-of-coefficient test to assess the mediating effects of behaviour change.
Baseline data were available 384 participants in the intervention group and 315 in the control group. Twelve month data were available for 355 in the intervention group and 300 in the control group. The K10 score of patients in the intervention group (14.78, SD 5.74) was lower at 12 months compared to the control group (15.97, SD 6.30). K10 at 12 months was significantly associated with the score at baseline and being unable to work but not with age, gender, change in behavioural risk factors or change in BMI.
The reduction of K10 in the intervention group demonstrates that a general practice based intervention to identify and manage vascular risk factors did not adversely impact on the psychological distress of the participants. The impact of the intervention on distress was not mediated by a change in the behavioural risk factors or BMI, suggesting that there must be other mediators that might explain the positive impact of the intervention on emotional wellbeing.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12607000423415.
Behavioural and physiological risk factors for vascular disease are common in patients presenting to Australian general practitioners
Lifestyle modification programs encourage participants to make significant changes through education, support and self-management strategies
The Health Improvement and Prevention Study was a cluster randomized controlled trial of vascular risk factor management in Australian general practice
Specifically this study aimed to 1. Investigate the psychological impact of participating in the intervention arm of the trial of vascular risk factor management and; 2. Identify the mediating effects of changes in behavioural risk factors (diet, physical activity, cigarette smoking and alcohol intake) or BMI. The study hypotheses were that patients who participated in the intervention arm of the trial would report lower psychological distress at 12 months, compared to patients in the control group; and that the reduction in psychological distress would be mediated by an improvement in one or more of their behavioural risk factors.
The Health Improvement and Prevention Study (HIPS) was a stratified cluster randomized controlled trial conducted in general practices in New South Wales, Australia (Australian New Zealand Clinical Trials Registry, ACTRN12607000423415). The methodology and outcomes of the trial have been described previously
The trial involved 30 practices who used electronic medical records and had expressed interest in the trial. Sixteen practices were randomly allocated to the study intervention group and 14 to the study control group. Patients were eligible to participate in the study if they had attended the practice in the preceding 12 months and were either aged 40–55 years with a diagnosis of hypertension and/or hyperlipidaemia or were aged 56–64 years with or without recorded risk factors. Exclusion criteria included diabetes, cardiovascular disease, current severe illness, inability to speak adequate English or understand the consent form. The majority of general practice patients aged over 64 years have already developed chronic disease so were not included. Each practice randomly selected up to 160 patients from practice records and invited them by mail to have fasting blood sugar and lipids levels; and attend their practice for a health check at baseline and 12 months.
The patients in the intervention practices attended for a structured health check visit. During the visit practice staff who had received prior training, assessed their vascular risk factors (blood pressure, lipids, fasting blood glucose, body mass index, waist circumference, smoking, nutrition, alcohol intake, and physical activity) and provided brief lifestyle advice and motivational interviewing. The brief intervention was modeled on the 5As framework (ask, assess, advise, assist and arrange)
Patients attending the control practices were also invited to attend the practice for a routine health check. At this they received usual general practice care for their risk factors by general practitioners who had not received the prior training.
Data collection
Patients, who were blinded to the practice allocation, were mailed a questionnaire at baseline and 12 months and asked to complete it in private before attending their practice for the health check. The questionnaire, based on previous research, collected self-reported behaviours
Self-reported behaviours included:
• Current smoking status
• Serves of fruit and vegetables per day (diet risk, <7 serves per day)
• Alcohol consumption (number of standard drinks on a typical day)
• Physical activity level (included duration of vigorous and moderate physical activity) (score range 0–8, Inactivity, <4)
Demographic information included gender, age and markers of socioeconomic status (home ownership and employment status)
The Kessler Psychological Distress Scale (K10)
Body Mass Index (BMI) was calculated using height and weight from audits of medical records at baseline and 12 months. A participant was considered "at risk" if their BMI ≥ 25 kg/m2
A statistician who was not involved in the data collection used computer generated random numbers to randomly allocate practices to intervention and control groups, stratified by location. Data collection officers were blinded to the allocation of practices.
Sample size calculation
A priori sample size calculation for the secondary analysis on the K10 score confirmed that 350 patients in each group would have 80% power and 5% significance level to detect an effect size of 0.28 between intervention and control groups at 12 months assuming 15% lost to follow-up after adjustment for clustering (ICC = 0.025)
The effect size was based on expert opinion. Larger effect sizes have been demonstrated in groups with a diagnosis of psychiatric disorder undergoing specific therapy but this population did not represent the participants in our study
Statistical analyses
We conducted bivariate analyses using ANCOVA or Chi-square (for categorical data) to test for differences between intervention and control groups at 12 months, using SPSS, version 15 (SPSS Inc)
Change in diet, BMI, physical activity and alcohol were examined as potential mediators of the lifestyle intervention effect on a change in psychological distress after adjustment for age, home ownership status and employment. Change variables were computed using the formula: 12 month score – baseline score. Smoking status was categorical and a change score was not computed. Therefore it was not included in the subsequent analysis.
To assess mediating effects, a product-of-coefficient test, appropriate for cluster randomized controlled trials, was used
Ethics approval for the study was obtained from the University of New South Wales (UNSW) Human Research and Ethics Committee. All participants gave fully informed written consent.
A total of 3128 patients from the 30 participating practices were approached to participate in the study and 958 (30.6%) consented. A higher number of patients from the intervention practices consented. Following exclusions and withdrawals baseline data were available for 699 participants (384 in the intervention group and 315 in the control group) and following loss to follow up, 12 month data for up to 655 participants (355 in the intervention group and 300 in the control group)
Figure 1
Participant recruitment, flow and follow-up
Participant recruitment, flow and follow-up.
Baseline characteristics
Bivariate analysis
The K10 score of the patients in the intervention group reduced between baseline and 12 months indicating lower distress, while the K10 score in the control group remained unchanged. There was a significant difference in K10 at 12 months between the intervention and control groups (F = 11.43, p = 0.001) (Table
There was no significant difference between intervention and control groups at 12 months for BMI, daily intake of fruit and vegetables, physical activity, smoking or alcohol intake (Table
Multilevel analysis
We examined the association between the intervention and K10 at 12 months using multilevel multivariable linear regression adjusted for patient characteristics and cluster effects. The K10 score of patients allocated to the intervention group was lower compared to the control group (Table
K10 at 12 months was not associated with the other markers of socioeconomic status, age, gender, change in any of the behavioural risk factors or change in BMI.
Mediation analysis
The change in K10 in the intervention group was not associated with change in any of the behavioural risk factors or BMI in the multiple-mediator model (Table
This analysis of a secondary outcome from a cluster randomized controlled trial of a general practice based health check to identify vascular risk factors, with referral of at risk patients to a lifestyle modification program demonstrated that the intervention reduced the psychological distress of the participants. The only primary outcome associated with the intervention, using multi-level, multi-variable analysis on an intention to treat basis and adjusted for patient and practice characteristics, time and cluster effects, was an increase in self-reported physical activity
Few previous intervention studies for the primary prevention of vascular disease have identified the emotional impact of their interventions. The reduction in psychological distress in this study was small however similar to other studies where the intervention was not specifically designed to reduce distress
Other studies have demonstrated a short term (4–6 weeks) increase in anxiety following screening but no longer term increase
We included socio-demographic variables in the analysis as these have been strongly associated with psychological distress
This study was designed to be conducted in conjunction with the primary HIPS study. The limitations of the HIPS study have already been reported
Our findings may not be generalisable to all general practices as a limited sample was chosen and only those interested responded to the invitation. Individual practices were randomized to intervention and control groups and it is unlikely that practitioners in the intervention group communicated with the control practices. The intervention was monitored by study facilitators and every attempt was made to ensure its fidelity. The patients were randomly chosen from practice records and their demographic characteristics, baseline behavioural risk factors and psychological distress were comparable to the general population
Australian general practice has an important role in screening for vascular risk factors and providing appropriate interventions. This study confirms that this process does not adversely impact on the psychological distress of our patients. Changes in behavioural risk factors or BMI did not mediate the intervention's impact on distress. There are a range of other potential mediating factors, including social support, that require further exploration.
ANCOVA: Analysis of covariance; BMI: Body mass index; HIPS: Health improvement and prevention study; ICC: Intraclass correlation coefficient; K10: Kessler psychological distress scale; SD: Standard deviation; UNSW: University of New South Wales.
Competing interests
The authors declare that they have no competing interests.
Authors' contributions
SM designed the study, conducted data analyses, interpreted the results and drafted the manuscript. UJ performed analysis and drafted the manuscript. MF coordinated the study and acquired the data. MP interpreted the results and drafted the manuscript. MH designed the study and interpreted the results. All authors have contributed to drafting and revising the manuscript; and approved the final manuscript.
Thank you to the other members of the Health Improvement and Prevention Study team including the other investigators, field officers and intervention staff. Special thanks to the general practitioners and patients who participated in the study.
The study was funded by a project grand (455268) from the Australian National Health and Medical Research Council.
A 3-year randomized trial of lifestyle intervention for cardiovascular risk reduction in the primary care setting: the Swedish Bjorknas study
Multiple risk factor interventions for primary prevention of coronary heart disease
Prevention of Type 2 diabetes melllitus by changes in lifestyle among subjects with impaired glucose tolerance
Emotional impact of screening: a systematic review and meta-analysis
Long-term cost-effectiveness of weight management in primary care
A cluster randomised controlled trial of vascular risk factor management in general practice
Bidirectional association between physical activity and symptoms of anxiety and depression: the Whitehall II study
Health improvement and prevention study (HIPS) - evaluation of an intervention to prevent vascular disease in general practice
Multilevel analysis of the chronic care model and the 5A services for treating tobacco use in urban primary care clinics
Predictors of primary care referrals to a vascular disease prevention lifestyle program among participants in a cluster randomised trial
Evaluation of the Counterweight Programme for obesity management in primary care: A starting point for continuous improvement
Health check for 45–49 year old patients in general practice: feasibility and impact on practices and patient behaviour
Interpreting scores on the Kessler Psychological Distress Scale (K10)
Reliability and validity of a brief physical activity assessment for use by family doctors
Quality of life of Australian chronically-ill adults: patient and practice characteristics matter
Measuring the effects of medical interventions
Generic effectiveness measures: sensitivity to symptom change in anxiety disorders
Patterns of intra-cluster correlation from primary care research to inform study design and analysis
ANCOVA versus change from baseline had more power in randomized studies and more bias in nonrandomized studies
Multilevel modeling of individual and group level mediated effects
Contrasts in multiple mediator models
Evaluating quality of life in hip and knee replacement: Psychometric properties of the World Health Organization Quality of Life short version instrument
Effectiveness of nurse home-visiting for disadvantaged families: results of a natural experiment
Self-efficacy: toward a unifying theory of behaviour change
Screening for type 2 diabetes is feasible, acceptable but associated with increased short-term anxiety: a randomized controlled trial in British general practice
Socio-demographic factors, behaviour and personality: associations with psychological distress
Socioeconomic correlates of generalised anxiety disorder and major depression in primary care
Shared variance among self-report and behavioral measures of distress intolerance
Pre-publication history
The pre-publication history for this paper can be accessed here:


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Tuesday, February 16, 2010
I Guess It Is Fat Tuesday
Enjoy Mardi Gras, or Carnival or whatever.
Posted by Zendo Deb at 2/16/2010 08:21:00 AM
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357 Magnum Archives- September 23, 2004 through August 23, 2012. A good run, but it is over now.
TFS Magnum HAS MOVED to 357 Magnum
Find current entries there!
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subset: commoncrawl


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with Chris Hedges
Redacted Tonight on Jan 13, 2017
Lee Camp kicks off the first Redacted Tonight VIP of 2017 with TWO interviews. Lee first talks with New York Times best-selling author Chris Hedges, host of On Contact and columnist for Truthdig. Hedges discusses how Deep State will play out in a Trump presidency. In the second half, Lee talks with JR Havlan, former writer for The Daily Show and his experiences covering political satire and its role in keeping the masses informed.


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- 12th April 2017
Happy Easter Folks!
Our office and warehouse will be closed for Easter from Friday 14th April to Monday 17th April, you can order online as usual but delivery times will vary.
Delivery Times:
All orders placed before Thursday 13th April 14:00 will be dispatched as normal.Permalink
Only express orders placed before Wednesday 12th April 14:00 are guaranteed to arrive before Easter.
Orders placed after Thursday 13th April 14:00 will be dispatched on Tuesday 18th April.
- 9th December 2016
Christmas Posting Dates 2016
Don't miss the Christmas posting dates 2016! Here are this years Christmas postal dates so we'll be sure to get your prezzies off on time.
UK Delivery
- Standard delivery order by Midday on Tuesday 20th December (there is NO tracking)
- Express delivery order by Midday on Thursday 22nd December (there IS tracking)
Republic of Ireland
- Standard delivery order by Midday Friday 16th December (there is NO tracking)
- Express delivery order by Midday Tuesday 20th December (available on request)
European Delivery
- Standard delivery order by Midday Friday 16th December (there is NO tracking)
- Express delivery order by Midday Tuesday 20th December (available on request)
Rest of the World Delivery
- Standard delivery has passed.
These dates are meant as guidelines and are not guaranteed. Please be aware that external factors beyond our control (such as snow, flooding, strikes, etc.) may delay your orders, so to avoid disappointment please don't leave it to the last minute.Permalink
- 29th November 2016
Your Top Tips for a Happy Christmas
Christmas is the most wonderful time of the year! At Farm Toys Online we want to make Christmas simple and stress-free, but sadly every year we do receive a handful of emails from customers having a meltdown on Christmas morning. So, here's our top tips for having a Happy Christmas with no disappointments!
1. When your Farm Toys Online delivery arrives, go through the order and check it is all there.
2. Open up toys before wrapping them. Don't worry about packaging and whether they will go back in the box in which they came. Check that all parts are there and nothing is broken.
3. If the toy needs to be assembled, assemble it before it gets wrapped. Take your time and read the manual. The best part? You won't have to worry about trying to do it on Christmas Eve, or even worse Christmas day with your mother-in-law and children hovering over you.
4. If you haven't stocked up while Christmas shopping, make sure you have all the batteries necessary for that remote control tractor.
If there are any issues with your delivery, email email@example.com right away - the sooner you get in touch, the sooner he can help! Farmer Freddie will be at work between Christmas and New Year; but many of our suppliers won't be, which means he won't be able to resolve your issues immediately.Permalink
- 10th November 2016
Christmas Shopping for Farm Kids
Our countdown to Christmas has officially started! This is the most exciting time of the year for us, we spend most of November and December picking and packing hundreds of toys for tractor-mad and horse-mad kids across the UK and we love it. But we know some parents that are filled with dread with even the mention of Christmas!
At Farm Toys Online we've tried to make buying presents for kids super easy with our one-stop shop selling fun, top quality farm toys. So whether you're buying for your farm-crazy children, nieces and nephews, grandchildren or friends' kids, you're sure to find something they'll love on the website.
Here our top three tips for finding the right toys this Christmas:
1. Think about the toy and the child
What does he or she enjoy playing right now? Give them the tools — the toys — that will help them to do it better whether that's a new trailer for a favourite tractor or accessories, like a grooming kit, to go with a horse.
2. Choose age-appropriate toys
Kids enjoy toys that they can master and that are right for their age. On the website you can hunt for farm toys which are designed for your kid's age by using the age range filter.
3. Remember what you liked as a kid
Farm toys from the likes of Britains and Siku have been around for decades – and they endure because they continue to capture kids' imaginations. The toys that once kept you busy for hours will most likely amuse your child, as well.
And because we know that sticking to a budget can be tricky, we're offering you free standard UK delivery this weekend on orders over £50. Enjoy!
- 22nd October 2016
Winners even if we didn't win the big prize!
Farm Toys Online has narrowly missed out on the Business of the Year Award at the prestigious Somerset Business Awards 2016, held on Friday 21st October.
Now in its 12th year, the Somerset Business Awards is one of Somerset's most high profile business events. With 13 categories in total, the event is designed to celebrate the companies in Somerset putting the county on the map, by boosting the economy and making a positive contribution to the local community.
Despite coming runners-up, we're extremely proud to have been shortlisted as a finalist for the Business of the Year Award, and to celebrate the success of just some of the many brilliant businesses based in Somerset. So we still feel like winners even if we didn't win the big prize and there's always next year folks...Permalink
- 11th October 2016
Pick your own pumpkin!
With Halloween on the horizon, Farmer Freddie has set off to find the perfect places for you to pick your own pumpkin.
Crockford Bridge Farm, Addlestone, Surrey
Offers pumpkin picking and spooky fun in the pumpkin patch from 15th - 30th October, including face painting and apple bobbing. Entry £1.
Piglets Adventure Farm, Towthorpe , North Yorkshire
There's 10,000 pumpkin to choose from on this 152-acre farm, with lots of spooky attractions and a free pumpkin for every child, there's so much family fun at Piglets Pumpkin Festival. Every day from 22nd – 30th October. Children £8.50, adults £7.50.
Darts Farm, Topsham, Devon
Pumpkin festival featuring Spookley the square pumpkin, also included are pumpkin treats, pumpkin decorating and a farm walk. Thursday 27th and Friday 28th October. Children 4 - 12, pre book event £7.95
Beluncle Farm, Hoo, Kent
A family farm that opens its gates to the public in October especially for pumpkin season. You can borrow a wheelbarrow to transport your haul, and a donation from the profits is made to their chosen charity Crohn's and Colitis UK and Crohn's in Childhood Research Association . Free entry, no booking required.
Craigies, South Queensferry, Edinburgh
October is pumpkin season at Craigies, they have a great crop of nice sized pumpkins this year. PYO from £4.00 to £6.50, free carving kit with each pumpkin.Permalink
- 7th October 2016
Top 8 Diggers for Children
Little JCB fans will love this great footage of JCBs! Fantastic episode on JCB construction vehicles and, of course, we have them all in toy version folks!Permalink
- 15th September 2016
It's OK to gloat, a bit.
Our very own Julia Lowe, Founder of Farm Toys Online, has been shortlisted in the Rural Business Awards for Rural Entrepreneur of the Year. The aim of the Rural Business Awards is to give recognition to businesses operating right across the rural sector and celebrate the achievements of rural businesses. The winners of the 13 award categories will be announced at a swanky award ceremony on the 13th October 2016 - so we'll be sure to keep you posted!
Julia is absolutely thrilled to have been shortlisted for such an great award and have her efforts recognised. A lot of thought has gone into every part of Farm Toys Online – from the different type of farm toys that we offer, to the way they are delivered – and it's lovely to know that people appreciate how hard we've worked to make it a fantastic rural business.
Wish her luck!
- 15th September 2016
Wish List
Farmer Freddie's got a lot on his wish list! Have you started one yet? All you need to do to create a wish list is register an account or log in to your account. When you find a toy you would like to save for later, simply click the 'add to wish list' button. The toy will be added to your Wish List.... Easy Peasy and you can share it with family or friends!
Click here to start yours.Permalink
- 4th May 2016
Interview with Julia Lowe!
Peek inside the world of Farm Toys Online founder Julia Lowe for a dose of your daily inspiration! Check out the full interview in Toys n Plaything magazine here http://bit.ly/1Tlo6gO.