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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
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnant Women focused on measuring pregnant women, gestational diabetes, Preventive Health, Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    September 25, 2022
    Last Updated
    April 12, 2023
    Sponsor
    Saglik Bilimleri Universitesi
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    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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