Gestational DiabetesNCT06436443
SMS Counseling on Gestational Diabetes
A study testing SMS Counseling in people with Gestational Diabetes, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- SMS Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2021to 24 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- being non-literate,
- having communication problems (hearing or sight),
- not volunteering to participate in the research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Burdur Mehmet Akif Ersoy University
Burdur, 15000
About this study
Official title: 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.
- Conditions
- Gestational Diabetes
- Being tested
- SMS Counseling
- Keywords
- Gestational diabetes mellitus,, Self-Efficacy,, SMS Counseling.
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS CounselingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | 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. Receives: Other: SMS Counseling |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Knowledge Scale
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.
Measured: 5 Minute
The Self-Efficacy Scale in Gestational Diabetes
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.
Measured: 5 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start15 Aug 2021
- Primary completion15 Mar 2022
- Study completion24 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurten Terkes, Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436443
- Sponsor's protocol ID
- MAKU GO 2020/193
- Status last verified
- May 2024
- First submitted
- 24 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All authors contributed to the interpretation, writing, and approval of the final manuscript.
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.
PubMed 29359166Guo 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.
PubMed 33914304Miremberg 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.
PubMed 29425836
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of SMS Counseling for Gestational Diabetes on Self-Efficacy and Knowledge Levels
- ClinicalTrials.gov ID
- NCT06436443
- Acronym / sponsor ID
- MAKU GO 2020/193
- Conditions
- Gestational Diabetes
- Keywords
- Gestational diabetes mellitus,, Self-Efficacy,, SMS Counseling.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 24 Apr 2022 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: SMS CounselingIn 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosed with gestational diabetes,
- being in the 30th week of pregnancy,
- having a smartphone,
- volunteering to participate in the study,
- having no communication problems,
Key exclusion criteria (3 listed)
- being non-literate,
- having communication problems (hearing or sight),
- not volunteering to participate in the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS CounselingIn 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. | Other | Intervention group |
Primary outcome
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.
The Self-Efficacy Scale in Gestational Diabetes
Time frame: 5 minute
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Results publication: PubMed 29359166Hemmati 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.
- Results publication: PubMed 33914304Guo 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.
- Results publication: PubMed 29425836Miremberg 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.
- Individual participant dataSharing planned: No. All authors contributed to the interpretation, writing, and approval of the final manuscript.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS Counseling in people with Gestational Diabetes, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Knowledge Scale (time frame: 5 Minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06436443, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.