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

NCT07762625 | Not Yet Recruiting

• 1 other identifier: 2025JK2117
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 6 months

• Body Mass Index

  Body mass index will be calculated as weight in kilograms divided by height in meters squared (kg/m²).

  Baseline, 3 months, and 6 months

Secondary Outcomes (16)

• Fasting Blood Glucose

  Baseline and 6 months

• Total Cholesterol

  Baseline and 6 months

• Triglycerides

  Baseline and 6 months

• High-Density Lipoprotein Cholesterol

  Baseline and 6 months

• Low-Density Lipoprotein Cholesterol

  Baseline and 6 months

Study Arms (2)

Couple-based Collaborative Lifestyle Intervention arm

EXPERIMENTAL

Women with a history of gestational diabetes and their spouses will receive a 3-month couple-based lifestyle intervention consisting of health modules delivered through health education posts, instant messages, and short videos.

Behavioral: Couple-based Collaborative Lifestyle Intervention

Woman-only Lifestyle Intervention arm

ACTIVE COMPARATOR

Women with a history of gestational diabetes will receive a 3-month lifestyle intervention delivered through health education posts, without the couple collaboration and support components (instant messages, and short videos).

Behavioral: Woman-only Lifestyle Intervention

Interventions

Couple-based Collaborative Lifestyle Intervention BEHAVIORAL

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.

Couple-based Collaborative Lifestyle Intervention arm

Woman-only Lifestyle Intervention BEHAVIORAL

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.

Woman-only Lifestyle Intervention arm

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For women:
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead
• Central South University: collaborator

Study Sites (3)

Changde First People's Hospital

Changde, Hunan, 415003, China

Location

Changsha Central Hospital

Changsha, Hunan, 410004, China

Location

General Hospital of Hunan University of Medicine

Huaihua, Hunan, 418000, China

Location

Study Officials

• Chunxia Cheng

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

CN (3)