Effectiveness of a Couple-Coordinated Lifestyle Intervention Among Women With a History of Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 362
- 试验地点
- 3
- 主要终点
- 2 h Oral Glucose Tolerance Test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Couple-based Collaborative Lifestyle Intervention (Behavioral)
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).
干预措施: Woman-only Lifestyle Intervention (Behavioral)
结局指标
主要结局
2 h Oral Glucose Tolerance Test
时间窗: 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
时间窗: Baseline, 3 months, and 6 months
Body mass index will be calculated as weight in kilograms divided by height in meters squared (kg/m²).
次要结局
- 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)
- Waist Circumference(Baseline, 3 months, and 6 months)
- Composite Z Score for Healthy Lifestyle Behavior(Baseline, 3 months, and 6 months)
- Diabetes Risk-Related Eating Behavior(Baseline, 3 months, and 6 months)
- Physical Activity(Baseline, 3 months, and 6 months)
- Depression(Baseline, 3 months, and 6 months)
- Perceived Stress(Baseline, 3 months, and 6 months)
- Dietary Self-Efficacy(Baseline, 3 months, and 6 months)
- Exercise Self-Efficacy(Baseline, 3 months, and 6 months)
- Couple Relationship Quality(Baseline, 3 months, and 6 months)
- Dyadic Coping Ability(Baseline, 3 months, and 6 months)
- Life Satisfaction(Baseline, 3 months, and 6 months)
研究者
Cheng chunxia
Chief Physician
The Third Xiangya Hospital of Central South University