Gestational Diabetes Management Based on Planned Behavior Theory

NCT04874922 | Completed DMC

• 1 other identifier: kocU-SDinmez
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Gestational

Keywords

Education, Nursing; Pregnancy Complications; Complications, Labor; Diabetes, Pregnancy-Induced

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  Data of each pregnant woman will be evaluated with Pregnancy Outcome Form for Mother and Baby in the postnatal period of 12 weeks.

Study Arms (2)

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.

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.

Behavioral: Gestational Diabetes Training Intervention based on standart

Interventions

Gestational Diabetes Training Intervention based on Planned Behavior Theory BEHAVIORAL

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.

Case group

Gestational Diabetes Training Intervention based on standart BEHAVIORAL

Standard training for gestational diabetes will be given once at 28 weeks of gestation.

Control Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: As the study was about pregnancy, only women were included.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Not having had a cesarean delivery before.

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Kafiye EROĞLU

Istanbul, 34520, Turkey (Türkiye)

Location

Related Publications (18)

• 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.

  PMID: 16731447 BACKGROUND

• Blue 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.

  PMID: 17620669 BACKGROUND

• Catalano 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.

  PMID: 27960609 BACKGROUND

• Farmer 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.

  PMID: 16492209 BACKGROUND

• Karacam 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.

  PMID: 31220964 BACKGROUND

• Rogozinska 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.

  PMID: 25719363 BACKGROUND

• ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.

  PMID: 29370047 RESULT

• American 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.

  PMID: 29222384 RESULT

• Ajzen I. The theory of planned behaviour: reactions and reflections. Psychol Health. 2011 Sep;26(9):1113-27. doi: 10.1080/08870446.2011.613995.

  PMID: 21929476 RESULT

• Akbar 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.

  PMID: 26844083 RESULT

• Aktun 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.

  PMID: 25788845 RESULT

• Ali 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.

  PMID: 21368321 RESULT

• Brown 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.

  PMID: 28472859 RESULT

• Coelho 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.

  PMID: 30088631 RESULT

• Griffith 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.

  PMID: 32526091 RESULT

• Jennings CA, Vandelanotte C, Caperchione CM, Mummery WK. Effectiveness of a web-based physical activity intervention for adults with Type 2 diabetes-a randomised controlled trial. Prev Med. 2014 Mar;60:33-40. doi: 10.1016/j.ypmed.2013.12.011. Epub 2013 Dec 15.

  PMID: 24345601 RESULT

• Jones EJ, Roche CC, Appel SJ. A review of the health beliefs and lifestyle behaviors of women with previous gestational diabetes. J Obstet Gynecol Neonatal Nurs. 2009 Sep-Oct;38(5):516-26. doi: 10.1111/j.1552-6909.2009.01051.x.

  PMID: 19883473 RESULT

• Zhang C, Tobias DK, Chavarro JE, Bao W, Wang D, Ley SH, Hu FB. Adherence to healthy lifestyle and risk of gestational diabetes mellitus: prospective cohort study. BMJ. 2014 Sep 30;349:g5450. doi: 10.1136/bmj.g5450.

  PMID: 25269649 RESULT

Related Links

• Republic of Turkey Ministry of Health antenatal care and management guide
• Republic of Turkey Ministry of Health-risk pregnancy care and management guide

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy Complications; Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kafiye EROĞLU, Prof.

  Koç University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 6, 2021
• Study Start: May 15, 2021
• Primary Completion: October 17, 2021
• Study Completion: November 27, 2021
• Last Updated: January 20, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)