## Protocol Section
### Identification Module
**NCT ID:** NCT06436443

**Brief Title:** SMS Counseling on Gestational Diabetes

**Official Title:** The Effect of SMS Counseling for Gestational Diabetes on Self-Efficacy and Knowledge Levels

#### Organization Study ID Info
**ID:** MAKU GO 2020/193
#### Organization
**Class:** OTHER
**Full Name:** Mehmet Akif Ersoy University
### Status Module
#### Completion Date
**Date:** 2022-04-24

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-03-15

**Type:** ACTUAL

#### Start Date
**Date:** 2021-08-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mehmet Akif Ersoy University

#### Responsible Party

**Investigator Affiliation:** Mehmet Akif Ersoy University

**Investigator Full Name:** Nurten Terkes

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The use of technology-based education and counseling services in the self-management of gestational diabetes contributes to better control of blood sugar levels, motivation and increased self-efficacy in women. Therefore, this study was planned as interventional research to determine the effect of SMS counseling given to individuals with gestational diabetes on self-efficacy and knowledge levels. This study was conducted descriptively with 95 patients with gestational diabetes who were treated in the endocrine service of a university hospital between August 15, 2021 and April 24, 2022. Personal information form created by the researchers, The Self-Efficacy Scale in Gestational Diabetes, and Diabetes Knowledge Scale were used to collect data.

### Conditions Module

**Conditions:**

- Gestational Diabetes

**Keywords:**

- Gestational diabetes mellitus,

- Self-Efficacy,

- SMS Counseling.

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Masking Description:** Single (Participant) They did not know if they were in the control and intervention group at the time of randomization.

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 95

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In addition to routine physician check-ups, an SMS group was created for the individuals in the intervention group, and basic information messages for diabetes control were sent to this group at regular intervals. In addition, individuals asked questions via this group. At the end of the eight-week follow-up, the data collection forms were filled out again and the study was terminated.

**Intervention Names:**

- Other: SMS Counseling

**Label:** Intervention group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** The same data collection forms were filled out at the first interview and eight weeks later by the pregnant women in the control group, and they continued to receive routine follow-ups.

**Label:** Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention group

**Description:** In addition to routine physician check-ups, an SMS group was created for the individuals in the intervention group, and basic information messages for diabetes control were sent to this group at regular intervals. In addition, individuals asked questions via this group. At the end of the eight-week follow-up, the data collection forms were filled out again and the study was terminated.

**Name:** SMS Counseling

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** This scale was first developed by Dunn et al.13 to measure diabetes knowledge. Afterward, it was developed by Carolan et al. to examine three effect domains: pregnant women's GDM knowledge, nutritional values, and GDM self-management principles. The scale consists of 18 questions. Cronbach's alpha value of the total scale was determined as 0.654.

**Measure:** Diabetes Knowledge Scale

**Time Frame:** 5 Minute

**Description:** This is a five-point Likert-type scale consisting of 23 items developed by Polat and Avdal in 2019 to evaluate the self-efficacy levels of individuals with gestational diabetes. It consists of four sub-dimensions: "diet-weight management"; "complication measures"; "compliance with nutrition education"; "medical therapy practices". As the total score on the scale increases, the level of self-efficacy increases, as well. Cronbach's alpha value of the total scale was determined as 0.654.

**Measure:** The Self-Efficacy Scale in Gestational Diabetes

**Time Frame:** 5 minute

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* diagnosed with gestational diabetes,
* being in the 30th week of pregnancy,
* having a smartphone,
* volunteering to participate in the study,
* having no communication problems,
* having no psychiatric problems

Exclusion Criteria:

* being non-literate,
* having communication problems (hearing or sight),
* not volunteering to participate in the research

**Gender Based:** True

**Gender Description:** Only women were taken.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Burdur

**Country:** Turkey

**Facility:** Burdur Mehmet Akif Ersoy University

**Zip:** 15000

### IPD Sharing Statement Module

**Description:** All authors contributed to the interpretation, writing, and approval of the final manuscript.

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Hemmati Maslakpak M, Razmara S, Niazkhani Z. Effects of Face-to-Face and Telephone-Based Family-Oriented Education on Self-Care Behavior and Patient Outcomes in Type 2 Diabetes: A Randomized Controlled Trial. J Diabetes Res. 2017;2017:8404328. doi: 10.1155/2017/8404328. Epub 2017 Nov 22.

**PMID:** 29359166

**Citation:** Guo Y, Zhou L, Sun B, Wang C, Zhang J. Application of online-offline integrated medical care management in patients with gestational diabetes. Ginekol Pol. 2021;92(10):720-725. doi: 10.5603/GP.a2021.0054. Epub 2021 Apr 29.

**PMID:** 33914304

**Citation:** Miremberg H, Ben-Ari T, Betzer T, Raphaeli H, Gasnier R, Barda G, Bar J, Weiner E. The impact of a daily smartphone-based feedback system among women with gestational diabetes on compliance, glycemic control, satisfaction, and pregnancy outcome: a randomized controlled trial. Am J Obstet Gynecol. 2018 Apr;218(4):453.e1-453.e7. doi: 10.1016/j.ajog.2018.01.044. Epub 2018 Feb 7.

**PMID:** 29425836

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M19012

- Name: Diabetes, Gestational

- Relevance: HIGH

- As Found: Gestational Diabetes

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016640

- Term: Diabetes, Gestational

- ID: D000003920

- Term: Diabetes Mellitus

### Misc Info Module

- Version Holder: 2024-05-31
