Couples, Diabetes Prevention, GDM, Lifestyle Intervention, Postpartum
Conditions
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.
Interventions
BEHAVIORALCouple-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.
BEHAVIORALWoman-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
The Third Xiangya Hospital of Central South University
Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2 h Oral Glucose Tolerance Test | Baseline and 6 months | 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. |
| Body Mass Index | Baseline, 3 months, and 6 months | Body mass index will be calculated as weight in kilograms divided by height in meters squared (kg/m²). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Blood Glucose | Baseline and 6 months | Fasting blood glucose will be measured from venous blood samples after an overnight fast and expressed in mmol/L. |
| Total Cholesterol | Baseline and 6 months | Total cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L. |
| Triglycerides | Baseline and 6 months | Triglycerides will be measured from venous blood samples after an overnight fast and expressed in mmol/L. |
| High-Density Lipoprotein Cholesterol | Baseline and 6 months | High-density lipoprotein cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L. |
| Low-Density Lipoprotein Cholesterol | Baseline and 6 months | Low-density lipoprotein cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L. |
| Waist Circumference | Baseline, 3 months, and 6 months | 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. |
| Composite Z Score for Healthy Lifestyle Behavior | Baseline, 3 months, and 6 months | A composite healthy lifestyle behavior score will be calculated by standardizing behavior measures into Z scores. |
| Diabetes Risk-Related Eating Behavior | Baseline, 3 months, and 6 months | Diabetes risk-related eating behaviors will be assessed using the Diabetes Risk-Related Eating Behavior Scale. |
| Physical Activity | Baseline, 3 months, and 6 months | Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form. |
| Depression | Baseline, 3 months, and 6 months | Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire. |
| Perceived Stress | Baseline, 3 months, and 6 months | Perceived stress will be assessed using the Perceived Stress Scale. |
| Dietary Self-Efficacy | Baseline, 3 months, and 6 months | Confidence in adopting and maintaining healthy dietary behaviors will be assessed using the Dietary Self-Efficacy Scale. |
| Exercise Self-Efficacy | Baseline, 3 months, and 6 months | Confidence in engaging in and maintaining physical activity will be assessed using the Exercise Self-Efficacy Scale. |
| Couple Relationship Quality | Baseline, 3 months, and 6 months | Couple Relationship Quality will be assessed using the Marital Satisfaction Subscale. |
| Dyadic Coping Ability | Baseline, 3 months, and 6 months | Dyadic Coping Ability will be assessed using the Dyadic Coping Scale. |
| Life Satisfaction | Baseline, 3 months, and 6 months | Overall life satisfaction will be assessed using the Satisfaction With Life Scale. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORChunxia Cheng
The Third Xiangya Hospital of Central South University
Outcome results
None listed