Education of Pregnant Women at Risk of Gestational Diabetes
Primary Purpose
Pregnant Women, Gestational Diabetes
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Education on preventive health behaviors based on Pender's Health Promotion Model
Sponsored by
About this trial
This is an interventional prevention trial for Pregnant Women focused on measuring pregnant women, gestational diabetes, Preventive Health, Education
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Education
Control
Arm Description
A minimum of 12-week training program and follow-up based on Pender's Health Promotion Model is planned until the 24th gestational week.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05568277
First Posted
September 25, 2022
Last Updated
April 12, 2023
Sponsor
Saglik Bilimleri Universitesi
1. Study Identification
Unique Protocol Identification Number
NCT05568277
Brief Title
Education of Pregnant Women at Risk of Gestational Diabetes
Official Title
Evaluation of the Effectiveness of the Education Provided to Pregnant Women at Risk of Gestational Diabetes on Preventive Health Behaviors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Gestational diabetes mellitus (GDM) is carbohydrate intolerance of varying degrees that begins during pregnancy or is first diagnosed during pregnancy. 4% of pregnancies are complicated by GDM. History of diabetes in first-degree relatives, history of GDM in previous pregnancies, body mass index over 30 kg/m2, significant weight gain during pregnancy, and maternal age over 25 are among the primary risk factors for gestational diabetes in pregnant women. Gestational diabetes; It causes serious maternal and fetal complications such as the risk of developing Type 2 diabetes in the mother, traumatic birth, preeclampsia, cesarean delivery, macrosomic baby, and congenital malformations.
It is known that healthy lifestyle behaviors are as effective as genetic factors in the development of diabetes. Lifestyle behavior modification is an essential component of gestational diabetes management. Studies show that 70-85% of pregnant women can control diabetes only with lifestyle changes. Protective health behaviors such as being at an ideal weight, eating healthy, exercising regularly and not smoking prevent the development of gestational diabetes. As a result of the Finnish Gestational Diabetes Prevention Study (RADIEL), it was found that physical activity and dietary intervention decreased the incidence of GDM by 36% in high-risk women. It is important that these preventive health behaviors are adopted and maintained by the pregnant woman. For this purpose, it is necessary to determine the problems in the process of acquiring behaviors that protect and improve health and prevent negative behaviors. Self-efficacy level plays an important role in initiating and maintaining preventive health behaviors. Education on preventive health behaviors can improve and improve self-care behaviors by increasing the self-efficacy level of women at risk of gestational diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnant Women, Gestational Diabetes
Keywords
pregnant women, gestational diabetes, Preventive Health, Education
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
intervention and control group
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Education
Arm Type
Experimental
Arm Description
A minimum of 12-week training program and follow-up based on Pender's Health Promotion Model is planned until the 24th gestational week.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education on preventive health behaviors based on Pender's Health Promotion Model
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pregnancy Physical Activity Questionnaire (PPAQ)
Description
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.
Time Frame
Baseline and between 30-32. gestational week
Title
Healthy Lifestyle Behaviours in Pregnancy Scale
Description
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.
Time Frame
Baseline and between 30-32. gestational week
Title
Pregnancy Risk Perception Questionnaire (PRPQ)
Description
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.
Time Frame
Baseline and between 30-32. gestational week
Title
Diabetes Self-Efficacy Scale
Description
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.
Time Frame
between 30-32. gestational week
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burcin Bektas Pardes
Phone
5545680840
Email
burcinbektas.pardes@sbu.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Gulten Guvenc
Phone
+905366700321
Email
gulten.guvenc@sbu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulten Guvenc
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This study is planned as a doctoral dissertation.
Citations:
PubMed Identifier
30214318
Citation
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.
Results Reference
result
PubMed Identifier
26223239
Citation
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. Erratum In: Diabetes Care. 2017 Jun 14;:
Results Reference
result
PubMed Identifier
25220104
Citation
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.
Results Reference
result
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Education of Pregnant Women at Risk of Gestational Diabetes
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