Couple-Coordinated Lifestyle Intervention for Women With a History of Gestational Diabetes Mellitus

Effectiveness of a Couple-Coordinated Lifestyle Intervention Among Women With a History of Gestational Diabetes Mellitus

Registry ID
NCT07762625
Source registry
NCT
Status
NOT_YET_RECRUITING
Phase
NA
Study type
INTERVENTIONAL
Sponsor
The Third Xiangya Hospital of Central South University
Enrollment
362
Start date
2026-08-15
Completion date
2028-08-30
Last update
2026-08-13

Conditions

Summary

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.

Interventions

Inclusion criteria

Inclusion Criteria: 1. For women: * 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. * Able to use a smartphone. * Willing to participate in the study. 2. For spouses: * Living with an eligible woman with a history of gestational diabetes mellitus. * Have basic literacy and sufficient cognitive and physical ability to participate in the study. * Able to use a smartphone. * Willing to participate in the study.

Exclusion criteria

Exclusion Criteria: 1. For women: * 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. * A contraindication to postpartum exercise. * Current participation in another lifestyle intervention program. 2. For spouses: * A diagnosed major chronic disease, such as coronary heart disease or diabetes, or another serious physical illness. * Cognitive impairment or a serious psychiatric disorder. * Current participation in another lifestyle intervention program. Women with a history of gestational diabetes mellitus and their spouses will be recruited during postpartum follow-up visits at the participating hospitals. Both members of the couple must meet their respective eligibility criteria.

Primary outcomes

[{"measure":"2 h Oral Glucose Tolerance Test","timeFrame":"Baseline and 6 months"},{"measure":"Body Mass Index","timeFrame":"Baseline, 3 months, and 6 months"}]

Locations

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