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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-40
SponsorThe Third Xiangya Hospital of Central South University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

362 Participants
are divided into 2 treatment groups
Group A: Couple-based Collaborative Lifestyle Intervention armExperimental treatment 1 intervention
Group B: Woman-only Lifestyle Intervention armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 6 months
2

Body Mass Index

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

Time frame
Baseline, 3 months, and 6 months

Secondary outcomes

1

Fasting Blood Glucose

Fasting blood glucose will be measured from venous blood samples after an overnight fast and expressed in mmol/L.

Time frame
Baseline and 6 months
2

Total Cholesterol

Total cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.

Time frame
Baseline and 6 months
3

Triglycerides

Triglycerides will be measured from venous blood samples after an overnight fast and expressed in mmol/L.

Time frame
Baseline and 6 months
4

High-Density Lipoprotein Cholesterol

High-density lipoprotein cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.

Time frame
Baseline and 6 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: