- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06436443
SMS Counseling on Gestational Diabetes
May 24, 2024 updated by: Nurten Terkes, Mehmet Akif Ersoy University
The Effect of SMS Counseling for Gestational Diabetes on Self-Efficacy and Knowledge Levels
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Burdur, Turkey, 15000
- Burdur Mehmet Akif Ersoy University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Intervention group
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.
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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.
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No Intervention: Control Group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diabetes Knowledge Scale
Time Frame: 5 Minute
|
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.
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5 Minute
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The Self-Efficacy Scale in Gestational Diabetes
Time Frame: 5 minute
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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.
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5 minute
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2021
Primary Completion (Actual)
March 15, 2022
Study Completion (Actual)
April 24, 2022
Study Registration Dates
First Submitted
May 24, 2024
First Submitted That Met QC Criteria
May 24, 2024
First Posted (Actual)
May 31, 2024
Study Record Updates
Last Update Posted (Actual)
May 31, 2024
Last Update Submitted That Met QC Criteria
May 24, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAKU GO 2020/193
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All authors contributed to the interpretation, writing, and approval of the final manuscript.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gestational Diabetes
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IRCCS Burlo GarofoloCompletedGestational Diabetes | Gestational Diabetes Mellitus | Pregnancy-Induced Diabetes | Diabetes Mellitus, Gestational | Diabetes, Pregnancy InducedIsrael, Italy, Netherlands, Slovenia, Sri Lanka
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Royal College of Surgeons, IrelandHealth Research Board - Trials Methodology Research NetworkCompletedPre-Gestational DiabetesIreland
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University of Texas Southwestern Medical CenterCompletedMild Gestational DiabetesUnited States
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