Couple-Coordinated Lifestyle Intervention for Women With a History of Gestational Diabetes Mellitus
NCT07762625 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 362
Last updated 2026-08-13
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.
Conditions
- Diabetes Prevention
- GDM
- Lifestyle Intervention
- Couples
- Postpartum
Interventions
- BEHAVIORAL
-
Couple-based Collaborative Lifestyle Intervention
Couples 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.
- BEHAVIORAL
-
Woman-only Lifestyle Intervention
Women 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.
Sponsors & Collaborators
-
Central South University
collaborator OTHER -
The Third Xiangya Hospital of Central South University
lead OTHER
Principal Investigators
-
Chunxia Cheng · The Third Xiangya Hospital of Central South University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-08-15
- Primary Completion
- 2028-08-30
- Completion
- 2028-08-30
Countries
- China
Study Locations
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