Education of Pregnant Women at Risk of Gestational Diabetes

NCT05568277 | Unknown

• 1 other identifier: bpardes1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

There are studies in the literature showing that there is a decrease in the number of pregnant women diagnosed with gestational diabetes and improvements in parameters related to maternal and infant health, with the education to be given to pregnant women at risk of gestational diabetes on preventive lifestyle practices such as healthy nutrition, physical exercise, and coping with stress. The aim of this study; For pregnant women at risk of gestational diabetes; education on preventive health behaviors; It is to determine the level of knowledge about GDM, risk perception and its effect on healthy living behaviors.

Conditions

Pregnant Women; Gestational Diabetes

Keywords

pregnant women; gestational diabetes; Preventive Health; Education

Outcome Measures

Primary Outcomes (4)

• Pregnancy Physical Activity Questionnaire (PPAQ)

  The questionnaire, which determines the physical activity and exercise levels of pregnant women, consists of 35 questions. With this scale, housework and care activities of pregnant women (n=13), occupational activities (n=5), sports and exercise activities (n=8), transportation (n=3) and sedentary life (n=3) 32 activities are evaluated. The intensity of physical activity performed on the scale is expressed as MET (metabolic equivalent). When calculating the weekly energy expenditure of the activities, the time spent for each activity and the MET value of the activity are multiplied and the scores are expressed as MET hours per week (MET-hours/week). MET values vary according to the type of activity. Activity intensities are grouped as sedentary (\<1.5 METs), mild (1.5-3.0 METs), moderate (3.0-6.0 METs), and severe (\>0.6 METs). Following those calculations, women are classified as having a sedentary, light, moderate or severe physical activity levels.

  Baseline and between 30-32. gestational week

• Healthy Lifestyle Behaviours in Pregnancy Scale

  The Healthy Life Behaviors Scale in Pregnant Women is a five-point Likert-type scale filled in by the pregnant women themselves. The scale consists of a total of 29 items and 6 subscales: responsibility for pregnancy, hygiene, nutrition, physical activity, travel and acceptance of pregnancy. Each subscale of the scale can be used alone in studies. Scale items are scored from 5 to 1 from "always" to "never". There is no reverse entry item in the scale. High scores obtained from the scale indicate that pregnant women exhibit healthy lifestyle behaviors.

  Baseline and between 30-32. gestational week

• Pregnancy Risk Perception Questionnaire (PRPQ)

  It is a self-report questionnaire consisting of 9 visual analogue scales designed to measure a pregnant woman's perception of her pregnancy risks. This questionnaire consists of two subscales that include four questions about the risk to self (mother) and five questions about risk to the baby. Participants are asked to place a vertical mark on each item along a line giving a score between 0-100 to indicate their risk assessment. Total Pregnancy Risk Perception Questionnaire score is obtained by adding the score for each of the 9 items, and then dividing by 9. Higher scores indicate higher levels of perceived risk.

  Baseline and between 30-32. gestational week

• Diabetes Self-Efficacy Scale

  The scale was developed to determine the self-efficacy of the patients with diabetes. The Likert-type scale consists of 8 items. The items of the scale are scored between 1 and 10 (1-Not at all confident, 10-Totally confident). The scale is usually applied within 5-6 minutes.

  between 30-32. gestational week

Study Arms (2)

Education

EXPERIMENTAL

A minimum of 12-week training program and follow-up based on Pender's Health Promotion Model is planned until the 24th gestational week.

Behavioral: Education on preventive health behaviors based on Pender's Health Promotion Model

Control

NO INTERVENTION

No intervention will be made by the researcher and they will receive routine antenatal care. After the post-test data are collected, the education booklet prepared by the researcher will be given to the pregnant women and sent to their e-mail addresses.

Interventions

Education on preventive health behaviors based on Pender's Health Promotion Model BEHAVIORAL

Pregnant women included in the study will be given education on preventive health behaviors based on Pender's Health Promotion Model on the prevention of gestational diabetes over the web (ZOOM/Teams etc.) every two weeks. Pregnant women's questions will be answered. At the end of each training, data will be collected from pregnant women and follow-up charts will be filled. The education booklet prepared by the researcher will be given to the pregnant women after the first education and will be sent to their e-mail addresses.

Education

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being between the 8th and 12th gestational weeks,
• Having risk factors for GDM (BMI of 30 kg/m2 and above, presence of diabetes in 1st degree relatives, diagnosis of GDM in previous pregnancy), being over 18 years old)
• Having a singleton pregnancy
• Ability to read and write Turkish
• Volunteering to participate in the study

You may not qualify if:

• Being older than 12 weeks of pregnancy
• Not having risk factors for GDM (BMI of 30 kg/m2 and above, presence of diabetes in 1st degree relatives, diagnosis of GDM in previous pregnancy), being over 18 years old)
• Having a multiple pregnancy
• Inability to read and write Turkish
• Not volunteering to participate in the study

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Related Publications (3)

• Rono K, Stach-Lempinen B, Eriksson JG, Poyhonen-Alho M, Klemetti MM, Roine RP, Huvinen E, Andersson S, Laivuori H, Valkama A, Meinila J, Kautiainen H, Tiitinen A, Koivusalo SB. Prevention of gestational diabetes with a prepregnancy lifestyle intervention - findings from a randomized controlled trial. Int J Womens Health. 2018 Aug 27;10:493-501. doi: 10.2147/IJWH.S162061. eCollection 2018.

  PMID: 30214318 RESULT

• Koivusalo SB, Rono K, Klemetti MM, Roine RP, Lindstrom J, Erkkola M, Kaaja RJ, Poyhonen-Alho M, Tiitinen A, Huvinen E, Andersson S, Laivuori H, Valkama A, Meinila J, Kautiainen H, Eriksson JG, Stach-Lempinen B. Gestational Diabetes Mellitus Can Be Prevented by Lifestyle Intervention: The Finnish Gestational Diabetes Prevention Study (RADIEL): A Randomized Controlled Trial. Diabetes Care. 2016 Jan;39(1):24-30. doi: 10.2337/dc15-0511. Epub 2015 Jul 29.

  PMID: 26223239 RESULT

• Chasan-Taber L. Lifestyle interventions to reduce risk of diabetes among women with prior gestational diabetes mellitus. Best Pract Res Clin Obstet Gynaecol. 2015 Jan;29(1):110-22. doi: 10.1016/j.bpobgyn.2014.04.019. Epub 2014 Aug 19.

  PMID: 25220104 RESULT

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

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

Study Officials

• Gulten Guvenc

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Central Study Contacts

Burcin Bektas Pardes

CONTACT

5545680840; burcinbektas.pardes@sbu.edu.tr

Gulten Guvenc

CONTACT

+905366700321; gulten.guvenc@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: intervention and control group

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: October 5, 2022
• Study Start: April 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 13, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share