NCT Number: NCT07762625
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.
Trial opening soon.
Get Notified20 year–40 year
All sexes
Interventional
Not applicable
Changde First People's Hospital, Changde, Hunan, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 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.
Time frame: Baseline, 3 months, and 6 months
Body mass index will be calculated as weight in kilograms divided by height in meters squared (kg/m²).
Time frame: Baseline and 6 months
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
Total cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
Time frame: Baseline and 6 months
Triglycerides will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
Time frame: Baseline and 6 months
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
Low-density lipoprotein cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
Time frame: 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.
Time frame: Baseline, 3 months, and 6 months
A composite healthy lifestyle behavior score will be calculated by standardizing behavior measures into Z scores.
Time frame: Baseline, 3 months, and 6 months
Diabetes risk-related eating behaviors will be assessed using the Diabetes Risk-Related Eating Behavior Scale.
Time frame: Baseline, 3 months, and 6 months
Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form.
Time frame: Baseline, 3 months, and 6 months
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire.
Time frame: Baseline, 3 months, and 6 months
Perceived stress will be assessed using the Perceived Stress Scale.
Time frame: Baseline, 3 months, and 6 months
Confidence in adopting and maintaining healthy dietary behaviors will be assessed using the Dietary Self-Efficacy Scale.
Time frame: Baseline, 3 months, and 6 months
Confidence in engaging in and maintaining physical activity will be assessed using the Exercise Self-Efficacy Scale.
Time frame: Baseline, 3 months, and 6 months
Couple Relationship Quality will be assessed using the Marital Satisfaction Subscale.
Time frame: Baseline, 3 months, and 6 months
Dyadic Coping Ability will be assessed using the Dyadic Coping Scale.
Time frame: Baseline, 3 months, and 6 months
Overall life satisfaction will be assessed using the Satisfaction With Life Scale.
The Third Xiangya Hospital of Central South University
Other
Effectiveness of a Couple-Coordinated Lifestyle Intervention Among Women With a History of Gestational Diabetes Mellitus
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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