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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lifestyle Intervention; Diabetes Prevention; Postpartum; Couples; GDM
• Intervention / Treatment: Behavioral: Couple-based Collaborative Lifestyle Intervention; Behavioral: Woman-only Lifestyle Intervention

• Study Type: Interventional
• Enrollment (Estimated): 362
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changde, Hunan, China, 415003
      • Changde First People's Hospital
      • Contact: Jing Zhang; Phone Number: 86 13873614102; Email: zhang.jing254x@163.com
    • Changsha, Hunan, China, 410004
      • Changsha Central Hospital
      • Contact: Tao Liu; Phone Number: 86 18173164259; Email: 92094418@qq.com
    • Huaihua, Hunan, China, 418000
      • General Hospital of Hunan University of Medicine
      • Contact: Fuyan Tan; Phone Number: 86 15115154712; Email: 328407894@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Couple-based Collaborative Lifestyle Intervention arm; 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; 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.
Active Comparator: Woman-only Lifestyle Intervention arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Blood Glucose	Fasting blood glucose will be measured from venous blood samples after an overnight fast and expressed in mmol/L.	Baseline and 6 months
Total Cholesterol	Total cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.	Baseline and 6 months
Triglycerides	Triglycerides will be measured from venous blood samples after an overnight fast and expressed in mmol/L.	Baseline and 6 months
High-Density Lipoprotein Cholesterol	High-density lipoprotein cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.	Baseline and 6 months
Low-Density Lipoprotein Cholesterol	Low-density lipoprotein cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.	Baseline and 6 months
Waist Circumference	Waist circumference will be measured with the participant standing, using a non-stretchable measuring tape positioned horizontally one fingerbreadth above the umbilicus, and recorded in centimeters.	Baseline, 3 months, and 6 months
Composite Z Score for Healthy Lifestyle Behavior	A composite healthy lifestyle behavior score will be calculated by standardizing behavior measures into Z scores.	Baseline, 3 months, and 6 months
Diabetes Risk-Related Eating Behavior	Diabetes risk-related eating behaviors will be assessed using the Diabetes Risk-Related Eating Behavior Scale.	Baseline, 3 months, and 6 months
Physical Activity	Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form.	Baseline, 3 months, and 6 months
Depression	Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire.	Baseline, 3 months, and 6 months
Perceived Stress	Perceived stress will be assessed using the Perceived Stress Scale.	Baseline, 3 months, and 6 months
Dietary Self-Efficacy	Confidence in adopting and maintaining healthy dietary behaviors will be assessed using the Dietary Self-Efficacy Scale.	Baseline, 3 months, and 6 months
Exercise Self-Efficacy	Confidence in engaging in and maintaining physical activity will be assessed using the Exercise Self-Efficacy Scale.	Baseline, 3 months, and 6 months
Couple Relationship Quality	Couple Relationship Quality will be assessed using the Marital Satisfaction Subscale.	Baseline, 3 months, and 6 months
Dyadic Coping Ability	Dyadic Coping Ability will be assessed using the Dyadic Coping Scale.	Baseline, 3 months, and 6 months
Life Satisfaction	Overall life satisfaction will be assessed using the Satisfaction With Life Scale.	Baseline, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University
• Collaborators: Central South University
• Investigators: Principal Investigator: Chunxia Cheng, The Third Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028

Study Registration Dates

• First Submitted: August 8, 2026
• First Submitted That Met QC Criteria: August 8, 2026
• First Posted (Actual): August 13, 2026

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 8, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025JK2117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No