Diabetes Mellitus, GestationalNCT04874922
Gestational Diabetes Management Based on Planned Behavior Theory
A study testing Gestational Diabetes Training Intervention based on Planned Behavior Theory and Gestational Diabetes Training Intervention based on standart in people with Diabetes Mellitus, Gestational, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
Our study was planned as a randomized controlled trial in order to determine the effect of Planned Behavior Theory based training model on diabetes management and pregnancy outcomes in women with Gestational Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Gestational
- What is being tested?
- Gestational Diabetes Training Intervention based on Planned Behavior Theory and Gestational Diabetes Training Intervention based on standart
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2021to 27 Nov 2021
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sample selection criteria describe pregnant women with personal contact information available who are diagnosed to have GDM between the weeks of 24-28 of their pregnancy, literate and capable of communicating in Turkish, not diagnosed to have GDM in their previous pregnancies, planning to deliver the child in the hospital where the research is to be conducted.
Who cannot join
- Not having had a cesarean delivery before.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Birth Outcome and Diabetes Management of Planned Behavior Theory Based Education Model in Women With Gestational Diabetes
Our study was planned as a randomized controlled trial in order to determine the effect of Planned Behavior Theory based training model on diabetes management and pregnancy outcomes in women with Gestational Diabetes Mellitus.
Read the detailed description
The trial will be conducted to evaluate the effectiveness of the model and to determine the impact of the Planned Behavior Theory based educational intervention on diabetes management and pregnancy outcomes.The research will be conducted in Women's Training and Research Hospitals in Istanbul. The sample group will be 70 subjects calculated by power analysis. Case and control groups will be determined by simple randomization. Sampling selection criteria; 24-28. they are pregnant women who are diagnosed with GDM between the weeks of gestation, can communicate in Turkish, are literate, have no GDM in their previous pregnancies, have a personal contact number and e-mail address, and plan to give birth at the hospital where the study will be conducted. Research data will be collected by the researcher between the 28th week of gestation and the 12th week of postpartum through the Diabetes Intention, Attitude and Behavior Questionnaire, Personal Data Collection Form, Metabolic Control Variables Form, Maternal and Infant Pregnancy Results Form. Case group; In addition to the training given in the hospital, the Training for Gestational Diabetes Based on Planned Behavior Theory will be given in three stages. Figures, percentage distributions, chi-square test, student t-test and analysis of variance will be used in the analysis of the data. As a result of the intervention made to the case group; It is expected to decrease complications due to diabetes in mothers, babies and newborns, to provide maternal metabolic control, to control the mother's weight and to shorten the duration of hospital stay.
- Conditions
- Diabetes Mellitus, Gestational
- Being tested
- Gestational Diabetes Training Intervention based on Planned Behavior Theory, Gestational Diabetes Training Intervention based on standart
- Keywords
- Education, Nursing, Pregnancy Complications, Complications, Labor, Diabetes, Pregnancy-Induced
- Medical subject headings
- Diabetes, Gestational, Pregnancy Complications, Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gestational Diabetes Training Intervention based on Planned Behavior TheoryBehavioural
On the basis of Planned Behavior Theory, an training intervention is planned in three stages for medical nutrition, physical activity and gestational diabetes follow-up.
Gestational Diabetes Training Intervention based on standartBehavioural
Standard training for gestational diabetes will be given once at 28 weeks of gestation.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | The case group will first receive standard diabetes training from the hospital. After 28-30. Diabetes training based on Planned Behavior Theory will be given three times between gestational weeks. Each training will take an average of 45 minutes. After that, the data evaluation phase will be started. Receives: Behavioral: Gestational Diabetes Training Intervention based on Planned Behavior Theory |
| Control Group | Other | The control group will only receive standart diabetes training from the hospital. Then, only follow-up will be done and the data will be evaluated. Receives: Behavioral: Gestational Diabetes Training Intervention based on standart |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolic control variables evaluation form (first)
It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.
Measured: The data of metabolic control variables of each pregnant woman at 28th gestational week will be evaluated.
metabolic control variables evaluation form (second)
It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.
Measured: The data of metabolic control variables of each pregnant woman at 32nd gestational week will be evaluated.
metabolic control variables evaluation form (third)
It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.
Measured: The data of metabolic control variables of each pregnant woman at her 36th gestational week will be evaluated.
metabolic control variables evaluation form (fourth)
It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.
Measured: The data of metabolic control variables of each pregnant woman at her 40th gestational week will be evaluated.
Secondary outcomes (1)
Pregnancy Outcomes Evaluation Form for Mother and Baby
This form evaluates the birth information of the mother and the baby, their health conditions and birth complications.
Measured: Data of each pregnant woman will be evaluated with Pregnancy Outcome Form for Mother and Baby in the postnatal period of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start15 May 2021
- Primary completion17 Oct 2021
- Study completion27 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, GestationalStudies 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
- Model description
- Pregnant women diagnosed with gestational diabetes will be assigned to the case and control groups in a randomized controlled manner (with simple random numbers table). Matching will be made between groups according to age and education level.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kafiye EROĞLU, Prof., Study director, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874922
- Sponsor's protocol ID
- kocU-SDinmez
- Status last verified
- Jun 2021
- First submitted
- 27 Apr 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blue CL, Marrero DG. Psychometric properties of the healthful eating belief scales for persons at risk of diabetes. J Nutr Educ Behav. 2006 May-Jun;38(3):134-42. doi: 10.1016/j.jneb.2006.01.010.
PubMed 16731447Blue CL, Marrero DG, Black DR. Physical activity belief scales for diabetes risk: development and psychometric testing. Health Educ Behav. 2008 Jun;35(3):316-31. doi: 10.1177/1090198106297060. Epub 2007 Jul 9.
PubMed 17620669Catalano HP, Knowlden AP, Birch DA, Leeper JD, Paschal AM, Usdan SL. Using the Theory of Planned Behavior to predict HPV vaccination intentions of college men. J Am Coll Health. 2017 Apr;65(3):197-207. doi: 10.1080/07448481.2016.1269771. Epub 2016 Dec 14.
PubMed 27960609Farmer A, Kinmonth AL, Sutton S. Measuring beliefs about taking hypoglycaemic medication among people with Type 2 diabetes. Diabet Med. 2006 Mar;23(3):265-70. doi: 10.1111/j.1464-5491.2005.01778.x.
PubMed 16492209Karacam Z, CelIk D. The prevalence and risk factors of gestational diabetes mellitus in Turkey: a systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2021 Apr;34(8):1331-1341. doi: 10.1080/14767058.2019.1635109. Epub 2019 Jul 2.
PubMed 31220964Rogozinska E, Chamillard M, Hitman GA, Khan KS, Thangaratinam S. Nutritional manipulation for the primary prevention of gestational diabetes mellitus: a meta-analysis of randomised studies. PLoS One. 2015 Feb 26;10(2):e0115526. doi: 10.1371/journal.pone.0115526. eCollection 2015.
PubMed 25719363ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
PubMed 29370047American Diabetes Association. 13. Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S137-S143. doi: 10.2337/dc18-S013.
PubMed 29222384Ajzen I. The theory of planned behaviour: reactions and reflections. Psychol Health. 2011 Sep;26(9):1113-27. doi: 10.1080/08870446.2011.613995.
PubMed 21929476Akbar H, Anderson D, Gallegos D. Predicting intentions and behaviours in populations with or at-risk of diabetes: A systematic review. Prev Med Rep. 2015 Apr 14;2:270-82. doi: 10.1016/j.pmedr.2015.04.006. eCollection 2015.
PubMed 26844083Aktun HL, Uyan D, Yorgunlar B, Acet M. Gestational diabetes mellitus screening and outcomes. J Turk Ger Gynecol Assoc. 2015 Mar 1;16(1):25-9. doi: 10.5152/jtgga.2015.15081. eCollection 2015.
PubMed 25788845Ali S, Dornhorst A. Diabetes in pregnancy: health risks and management. Postgrad Med J. 2011 Jun;87(1028):417-27. doi: 10.1136/pgmj.2010.109157. Epub 2011 Mar 2.
PubMed 21368321Brown J, Alwan NA, West J, Brown S, McKinlay CJ, Farrar D, Crowther CA. Lifestyle interventions for the treatment of women with gestational diabetes. Cochrane Database Syst Rev. 2017 May 4;5(5):CD011970. doi: 10.1002/14651858.CD011970.pub2.
PubMed 28472859Coelho MCVS, Almeida CAPL, Silva ARVD, Moura LKB, Feitosa LGGC, Nunes LB. Training in diabetes education: meanings attributed by primary care nurses. Rev Bras Enferm. 2018;71(suppl 4):1611-1618. doi: 10.1590/0034-7167-2017-0792. English, Portuguese.
PubMed 30088631Griffith RJ, Alsweiler J, Moore AE, Brown S, Middleton P, Shepherd E, Crowther CA. Interventions to prevent women from developing gestational diabetes mellitus: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2020 Jun 11;6(6):CD012394. doi: 10.1002/14651858.CD012394.pub3.
PubMed 32526091
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Birth Outcome and Diabetes Management of Planned Behavior Theory Based Education Model in Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT04874922
- Acronym / sponsor ID
- kocU-SDinmez
- Conditions
- Diabetes Mellitus, Gestational
- Keywords
- Education, Nursing, Pregnancy Complications, Complications, Labor, Diabetes, Pregnancy-Induced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 17 Oct 2021 (actual)
- Study completion
- 27 Nov 2021 (actual)
- First posted
- 6 May 2021 (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.
Our study was planned as a randomized controlled trial in order to determine the effect of Planned Behavior Theory based training model on diabetes management and pregnancy outcomes in women with Gestational Diabetes Mellitus.
Detailed description
The trial will be conducted to evaluate the effectiveness of the model and to determine the impact of the Planned Behavior Theory based educational intervention on diabetes management and pregnancy outcomes.The research will be conducted in Women's Training and Research Hospitals in Istanbul. The sample group will be 70 subjects calculated by power analysis. Case and control groups will be determined by simple randomization. Sampling selection criteria; 24-28. they are pregnant women who are diagnosed with GDM between the weeks of gestation, can communicate in Turkish, are literate, have no GDM in their previous pregnancies, have a personal contact number and e-mail address, and plan to give birth at the hospital where the study will be conducted. Research data will be collected by the researcher between the 28th week of gestation and the 12th week of postpartum through the Diabetes Intention, Attitude and Behavior Questionnaire, Personal Data Collection Form, Metabolic Control Variables Form, Maternal and Infant Pregnancy Results Form. Case group; In addition to the training given in the hospital, the Training for Gestational Diabetes Based on Planned Behavior Theory will be given in three stages. Figures, percentage distributions, chi-square test, student t-test and analysis of variance will be used in the analysis of the data. As a result of the intervention made to the case group; It is expected to decrease complications due to diabetes in mothers, babies and newborns, to provide maternal metabolic control, to control the mother's weight and to shorten the duration of hospital stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pregnant women diagnosed with gestational diabetes will be assigned to the case and control groups in a randomized controlled manner (with simple random numbers table). Matching will be made between groups according to age and education level.
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Behavioral: Gestational Diabetes Training Intervention based on Planned Behavior TheoryThe case group will first receive standard diabetes training from the hospital. After 28-30. Diabetes training based on Planned Behavior Theory will be given three times between gestational weeks. Each training will take an average of 45 minutes. After that, the data evaluation phase will be started. |
| Control Group | Other | Behavioral: Gestational Diabetes Training Intervention based on standartThe control group will only receive standart diabetes training from the hospital. Then, only follow-up will be done and the data will be evaluated. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Sample selection criteria describe pregnant women with personal contact information available who are diagnosed to have GDM between the weeks of 24-28 of their pregnancy, literate and capable of communicating in Turkish, not diagnosed to have GDM in their previous pregnancies, planning to deliver the child in the hospital where the research is to be conducted.
Key exclusion criteria (1 listed)
- Not having had a cesarean delivery before.
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 |
|---|---|---|
| Gestational Diabetes Training Intervention based on Planned Behavior TheoryOn the basis of Planned Behavior Theory, an training intervention is planned in three stages for medical nutrition, physical activity and gestational diabetes follow-up. | Behavioural | Case group |
| Gestational Diabetes Training Intervention based on standartStandard training for gestational diabetes will be given once at 28 weeks of gestation. | Behavioural | Control Group |
Primary outcome
metabolic control variables evaluation form (first)
Time frame: The data of metabolic control variables of each pregnant woman at 28th gestational week will be evaluated.
It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.
metabolic control variables evaluation form (second)
Time frame: The data of metabolic control variables of each pregnant woman at 32nd gestational week will be evaluated.
It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.
metabolic control variables evaluation form (third)
Time frame: The data of metabolic control variables of each pregnant woman at her 36th gestational week will be evaluated.
It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.
metabolic control variables evaluation form (fourth)
Time frame: The data of metabolic control variables of each pregnant woman at her 40th gestational week will be evaluated.
It is a form that evaluates the blood sugar, blood lipids, blood pressure, weight and insulin usage doses of pregnant women.
1 secondary outcome
Pregnancy Outcomes Evaluation Form for Mother and Baby
Time frame: Data of each pregnant woman will be evaluated with Pregnancy Outcome Form for Mother and Baby in the postnatal period of 12 weeks.
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 20 Jan 2022.
- Background: PubMed 16731447Blue CL, Marrero DG. Psychometric properties of the healthful eating belief scales for persons at risk of diabetes. J Nutr Educ Behav. 2006 May-Jun;38(3):134-42. doi: 10.1016/j.jneb.2006.01.010.
- Background: PubMed 17620669Blue CL, Marrero DG, Black DR. Physical activity belief scales for diabetes risk: development and psychometric testing. Health Educ Behav. 2008 Jun;35(3):316-31. doi: 10.1177/1090198106297060. Epub 2007 Jul 9.
- Background: PubMed 27960609Catalano HP, Knowlden AP, Birch DA, Leeper JD, Paschal AM, Usdan SL. Using the Theory of Planned Behavior to predict HPV vaccination intentions of college men. J Am Coll Health. 2017 Apr;65(3):197-207. doi: 10.1080/07448481.2016.1269771. Epub 2016 Dec 14.
- Background: PubMed 16492209Farmer A, Kinmonth AL, Sutton S. Measuring beliefs about taking hypoglycaemic medication among people with Type 2 diabetes. Diabet Med. 2006 Mar;23(3):265-70. doi: 10.1111/j.1464-5491.2005.01778.x.
- Background: PubMed 31220964Karacam Z, CelIk D. The prevalence and risk factors of gestational diabetes mellitus in Turkey: a systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2021 Apr;34(8):1331-1341. doi: 10.1080/14767058.2019.1635109. Epub 2019 Jul 2.
- Background: PubMed 25719363Rogozinska E, Chamillard M, Hitman GA, Khan KS, Thangaratinam S. Nutritional manipulation for the primary prevention of gestational diabetes mellitus: a meta-analysis of randomised studies. PLoS One. 2015 Feb 26;10(2):e0115526. doi: 10.1371/journal.pone.0115526. eCollection 2015.
- Results publication: PubMed 29370047ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
- Results publication: PubMed 29222384American Diabetes Association. 13. Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S137-S143. doi: 10.2337/dc18-S013.
- Results publication: PubMed 21929476Ajzen I. The theory of planned behaviour: reactions and reflections. Psychol Health. 2011 Sep;26(9):1113-27. doi: 10.1080/08870446.2011.613995.
- Results publication: PubMed 26844083Akbar H, Anderson D, Gallegos D. Predicting intentions and behaviours in populations with or at-risk of diabetes: A systematic review. Prev Med Rep. 2015 Apr 14;2:270-82. doi: 10.1016/j.pmedr.2015.04.006. eCollection 2015.
- Results publication: PubMed 25788845Aktun HL, Uyan D, Yorgunlar B, Acet M. Gestational diabetes mellitus screening and outcomes. J Turk Ger Gynecol Assoc. 2015 Mar 1;16(1):25-9. doi: 10.5152/jtgga.2015.15081. eCollection 2015.
- Results publication: PubMed 21368321Ali S, Dornhorst A. Diabetes in pregnancy: health risks and management. Postgrad Med J. 2011 Jun;87(1028):417-27. doi: 10.1136/pgmj.2010.109157. Epub 2011 Mar 2.
- Republic of Turkey Ministry of Health antenatal care and management guideLink provided by the sponsor.
- Republic of Turkey Ministry of Health-risk pregnancy care and management guideLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Kafiye EROĞLU, Prof. study director
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gestational Diabetes Training Intervention based on Planned Behavior Theory and Gestational Diabetes Training Intervention based on standart in people with Diabetes Mellitus, Gestational, run by Koç 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 1 inclusion and 1 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 20 Jan 2022. 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?
metabolic control variables evaluation form (first) (time frame: The data of metabolic control variables of each pregnant woman at 28th gestational week will be evaluated.). The study lists 4 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 NCT04874922, which also lists 19 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 20 Jan 2022.