CompletedNot Applicable

Effectiveness of a Pender's Health Promotion Model-Based Diabetes Self-Management Program in Gestational Diabetes: A Clinical Trial

Turkey (Türkiye)71 participantsStarted 2025-01-15

Plain-language summary

The aim was to evaluate the effect of a nursing education intervention based on Pender's SGM on gestational diabetes management and healthy lifestyle behaviors for pregnant women diagnosed with gestational diabetes. The main questions it aims to answer are: 1. Is there a difference between the total mean scores of the Healthy Lifestyle Behaviors Scale of the pregnant women in the intervention and control groups? 2. Is there a difference between the total mean scores of the Self-Efficacy in Gestational Diabetes Scale of the pregnant women in the intervention and control groups? 3. Is there a difference between the total mean scores of the Health Belief Model Scale in Diabetic Patients of the pregnant women in the intervention and control groups? 4. Is there a difference between the total mean scores of the Multidimensional Perceived Social Support Scale of the pregnant women in the intervention and control groups? 5. Is there a difference between the development of maternal complications (at least one complication) of the pregnant women in the intervention and control groups? 6. Is there a difference in the development of fetal complications (at least one complication) between the pregnant women in the intervention and control groups?

Who can participate

Age range

19 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Able to communicate in Turkish, * Not having conditions that would create communication problems (mental, visual, hearing impairment), * Graduated from at least secondary school, * Having a singleton pregnancy between the 24th and 28th weeks of pregnancy, * Not having been diagnosed with GDM in a previous pregnancy, * Not having been diagnosed with a risky pregnancy (adolescent pregnancy, preeclampsia, eclampsia, hypertension), * Not having a health problem that would prevent exercise (heart disease, respiratory diseases, risk of abortion, orthopedic problems), * Not having to follow a special diet program (Celiac disease, kidney disease, heart disease). * Not having a psychiatric diagnosis (psychosomatic disorders), * Having an endocrine disease known to affect blood glucose levels (hyperthyroidism, hypothyroidism). Exclusion Criteria: * Wanting to leave at any stage of the study, * Not participating in the program at least once after joining the study (Signature chart follow-up, detection of non-continuation of daily follow-up), * Being diagnosed with a risky pregnancy at any stage of the study (preeclampsia, eclampsia, premature membrane rupture, systemic disease) * Incompletely filling in the data collection forms applied during the program.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Health Belief Model Scale for Diabetes Patients

Timeframe: At 36-38 weeks of gestation

Gestational Diabetes Self-Efficacy Scale

Timeframe: At 36-38 weeks of gestation

Multidimensional Scale of Perceived Social Support

Timeframe: At 36-38 weeks of gestation

Trial details

NCT IDNCT07060963

SponsorAnkara Yildirim Beyazıt University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

Results submitted2025-12-15

View on ClinicalTrials.gov More Self-Efficacy for Decision Making trials

Plain-language summary

Who can participate

Age range

19 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.