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Gestational Diabetes Management Based on Planned Behavior Theory

NCT ID: NCT04874922

Last Updated: 2022-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-15

Study Completion Date

2021-11-27

Brief Summary

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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.

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Detailed Description

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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

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Diabetes Mellitus, Gestational

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Case group

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.

Group Type EXPERIMENTAL

Gestational Diabetes Training Intervention based on Planned Behavior Theory

Intervention Type 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.

Control Group

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.

Group Type OTHER

Gestational Diabetes Training Intervention based on standart

Intervention Type BEHAVIORAL

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

Interventions

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Gestational Diabetes Training Intervention based on Planned Behavior Theory

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.

Intervention Type BEHAVIORAL

Gestational Diabetes Training Intervention based on standart

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Not having had a cesarean delivery before.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Koç University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kafiye EROĞLU, Prof.

Role: STUDY_DIRECTOR

Koç University

Locations

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Kafiye EROĞLU

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 16731447 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17620669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27960609 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16492209 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31220964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25719363 (View on PubMed)

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

Reference Type RESULT
PMID: 29370047 (View on PubMed)

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.

Reference Type RESULT
PMID: 29222384 (View on PubMed)

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

Reference Type RESULT
PMID: 21929476 (View on PubMed)

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.

Reference Type RESULT
PMID: 26844083 (View on PubMed)

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.

Reference Type RESULT
PMID: 25788845 (View on PubMed)

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.

Reference Type RESULT
PMID: 21368321 (View on PubMed)

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.

Reference Type RESULT
PMID: 28472859 (View on PubMed)

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.

Reference Type RESULT
PMID: 30088631 (View on PubMed)

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.

Reference Type RESULT
PMID: 32526091 (View on PubMed)

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.

Reference Type RESULT
PMID: 24345601 (View on PubMed)

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.

Reference Type RESULT
PMID: 19883473 (View on PubMed)

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.

Reference Type RESULT
PMID: 25269649 (View on PubMed)

Related Links

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https://khgmsaglikhizmetleridb.saglik.gov.tr/TR,42839/dogum-oncesi-bakim-yonetim-rehberi.html

Republic of Turkey Ministry of Health antenatal care and management guide

https://khgmsaglikhizmetleridb.saglik.gov.tr/TR,42842/riskli-gebelik-yonetim-rehberi.html

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

Other Identifiers

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kocU-SDinmez

Identifier Type: -

Identifier Source: org_study_id

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