About this trial
The goal of this clinical trial is to evaluate the effects of a couple-based collaborative lifestyle intervention among women with a history of gestational diabetes. The main questions it aims to answer are:
Does the intervention improve body mass index and 2-hour plasma glucose after an oral glucose tolerance test? Does the intervention improve health behaviors, psychological well-being, self-efficacy, couple functioning, and life satisfaction?
Researchers will compare a couple-based collaborative lifestyle intervention with a woman-only lifestyle intervention to determine whether adding spousal collaboration and support leads to greater improvements.
Participants will:
Receive healthy lifestyle education posts for 3 months. In the couple-based group, also receive instant messages on behavioral promotion and couple collaboration and support videos.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
20 to 40 years of age.
Diagnosed with gestational diabetes mellitus during the most recent pregnancy.
Have basic literacy and sufficient cognitive and physical ability to participate in the study.
Living with their spouse.
Disqualifiers
Diabetes diagnosed before pregnancy or after delivery.
Pregnant at the time of screening.
Currently using medications that affect glucose metabolism or medications for weight loss.
Cognitive impairment or a serious psychiatric disorder.
Trial design
Parallel
Treatments tested in this trial
Couple-based Collaborative Lifestyle Intervention
BehavioralCouples will receive a 3-month lifestyle intervention delivered through health education posts, short videos, and instant messages. The intervention addresses healthy diet, physical activity, and stress management, with smoking cessation and alcohol reduction provided when applicable. Couple-specific components focus on role allocation, couple communication, and time management.
Woman-only Lifestyle Intervention
BehavioralWomen will receive a 3-month lifestyle intervention delivered through health education posts focusing on healthy diet, physical activity, and stress management, with smoking cessation and alcohol reduction provided when applicable. The intervention does not include the couple collaboration and support components provided in the experimental group.
Treatment groups
Trial outcomes
Primary outcomes
2 h Oral Glucose Tolerance Test
Two-hour plasma glucose will be measured 2 hours after a 75-g oral glucose load during an oral glucose tolerance test and reported in mmol/L.
Body Mass Index
Body mass index will be calculated as weight in kilograms divided by height in meters squared (kg/m²).
Secondary outcomes
Fasting Blood Glucose
Fasting blood glucose will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
Total Cholesterol
Total cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
Triglycerides
Triglycerides will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
High-Density Lipoprotein Cholesterol
High-density lipoprotein cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
Sponsors and contacts
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The Third Xiangya Hospital of Central South University
Lead sponsor
Central South University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: