Pregnant WomenNCT05568277
Education of Pregnant Women at Risk of Gestational Diabetes
A study testing Education on preventive health behaviors based on Pender's Health Promotion Model in people with Pregnant Women and Gestational Diabetes, run by Saglik Bilimleri Universitesi.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women, Gestational Diabetes
- What is being tested?
- Education on preventive health behaviors based on Pender's Health Promotion Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Effectiveness of the Education Provided to Pregnant Women at Risk of Gestational Diabetes on Preventive Health Behaviors
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.
Read the 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.
- Conditions
- Pregnant Women, Gestational Diabetes
- Being tested
- Education on preventive health behaviors based on Pender's Health Promotion Model
- Keywords
- pregnant women, gestational diabetes, Preventive Health, Education
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on preventive health behaviors based on Pender's Health Promotion ModelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: between 30-32. gestational week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study startApr 2023 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention and control group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Bektaş Pardes, Saglik Bilimleri Universitesi
- Investigators
- Gulten Guvenc, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568277
- Sponsor's protocol ID
- bpardes1
- Status last verified
- Sep 2022
- First submitted
- 25 Sep 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is planned as a doctoral dissertation.
Publications
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.
PubMed 30214318Koivusalo 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.
PubMed 26223239Chasan-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.
PubMed 25220104
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Education Provided to Pregnant Women at Risk of Gestational Diabetes on Preventive Health Behaviors
- ClinicalTrials.gov ID
- NCT05568277
- Acronym / sponsor ID
- bpardes1
- Conditions
- Pregnant Women, Gestational Diabetes
- Keywords
- pregnant women, gestational diabetes, Preventive Health, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- intervention and control group
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: Education on preventive health behaviors based on Pender's Health Promotion ModelA minimum of 12-week training program and follow-up based on Pender's Health Promotion Model is planned until the 24th gestational week. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education on preventive health behaviors based on Pender's Health Promotion ModelPregnant 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. | Behavioural | Education |
Primary outcome
Pregnancy Physical Activity Questionnaire (PPAQ)
Time frame: Baseline and between 30-32. gestational week
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
Time frame: Baseline and between 30-32. gestational week
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)
Time frame: Baseline and between 30-32. gestational week
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
Time frame: between 30-32. gestational week
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Results publication: PubMed 30214318Rono 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 publication: PubMed 26223239Koivusalo 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.
- Results publication: PubMed 25220104Chasan-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.
- Individual participant dataSharing planned: No. This study is planned as a doctoral dissertation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulten Guvenc study director
Saglik Bilimleri Universitesi
Questions about this trial
What is this clinical trial studying?
A study testing Education on preventive health behaviors based on Pender's Health Promotion Model in people with Pregnant Women and Gestational Diabetes, run by Saglik Bilimleri Universitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Burcin Bektas Pardes (5545680840, burcinbektas.pardes@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Physical Activity Questionnaire (PPAQ) (time frame: Baseline and between 30-32. gestational week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05568277, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.