Couple-Coordinated Lifestyle Intervention for Women With a History of Gestational Diabetes Mellitus
8 de agosto de 2026 actualizado por: Cheng chunxia, The Third Xiangya Hospital of Central South University
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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
362
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Hunan
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Changde, Hunan, Porcelana, 415003
- Changde First People's Hospital
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Contacto:
- Jing Zhang
- Número de teléfono: 86 13873614102
- Correo electrónico: zhang.jing254x@163.com
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Changsha, Hunan, Porcelana, 410004
- Changsha Central Hospital
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Contacto:
- Tao Liu
- Número de teléfono: 86 18173164259
- Correo electrónico: 92094418@qq.com
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Huaihua, Hunan, Porcelana, 418000
- General Hospital of Hunan University of Medicine
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Contacto:
- Fuyan Tan
- Número de teléfono: 86 15115154712
- Correo electrónico: 328407894@qq.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
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.
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:
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.
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
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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.
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|
Comparador activo: 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).
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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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
2 h Oral Glucose Tolerance Test
Periodo de tiempo: Baseline and 6 months
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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.
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Baseline and 6 months
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Body Mass Index
Periodo de tiempo: Baseline, 3 months, and 6 months
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Body mass index will be calculated as weight in kilograms divided by height in meters squared (kg/m²).
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Baseline, 3 months, and 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fasting Blood Glucose
Periodo de tiempo: Baseline and 6 months
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Fasting blood glucose will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
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Baseline and 6 months
|
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Total Cholesterol
Periodo de tiempo: Baseline and 6 months
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Total cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
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Baseline and 6 months
|
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Triglycerides
Periodo de tiempo: Baseline and 6 months
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Triglycerides will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
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Baseline and 6 months
|
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High-Density Lipoprotein Cholesterol
Periodo de tiempo: Baseline and 6 months
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High-density lipoprotein cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
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Baseline and 6 months
|
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Low-Density Lipoprotein Cholesterol
Periodo de tiempo: Baseline and 6 months
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Low-density lipoprotein cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
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Baseline and 6 months
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Waist Circumference
Periodo de tiempo: Baseline, 3 months, and 6 months
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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.
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Baseline, 3 months, and 6 months
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Composite Z Score for Healthy Lifestyle Behavior
Periodo de tiempo: Baseline, 3 months, and 6 months
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A composite healthy lifestyle behavior score will be calculated by standardizing behavior measures into Z scores.
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Baseline, 3 months, and 6 months
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Diabetes Risk-Related Eating Behavior
Periodo de tiempo: Baseline, 3 months, and 6 months
|
Diabetes risk-related eating behaviors will be assessed using the Diabetes Risk-Related Eating Behavior Scale.
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Baseline, 3 months, and 6 months
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Physical Activity
Periodo de tiempo: Baseline, 3 months, and 6 months
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Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form.
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Baseline, 3 months, and 6 months
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Depression
Periodo de tiempo: Baseline, 3 months, and 6 months
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Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire.
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Baseline, 3 months, and 6 months
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Perceived Stress
Periodo de tiempo: Baseline, 3 months, and 6 months
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Perceived stress will be assessed using the Perceived Stress Scale.
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Baseline, 3 months, and 6 months
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Dietary Self-Efficacy
Periodo de tiempo: Baseline, 3 months, and 6 months
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Confidence in adopting and maintaining healthy dietary behaviors will be assessed using the Dietary Self-Efficacy Scale.
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Baseline, 3 months, and 6 months
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Exercise Self-Efficacy
Periodo de tiempo: Baseline, 3 months, and 6 months
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Confidence in engaging in and maintaining physical activity will be assessed using the Exercise Self-Efficacy Scale.
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Baseline, 3 months, and 6 months
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Couple Relationship Quality
Periodo de tiempo: Baseline, 3 months, and 6 months
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Couple Relationship Quality will be assessed using the Marital Satisfaction Subscale.
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Baseline, 3 months, and 6 months
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Dyadic Coping Ability
Periodo de tiempo: Baseline, 3 months, and 6 months
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Dyadic Coping Ability will be assessed using the Dyadic Coping Scale.
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Baseline, 3 months, and 6 months
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Life Satisfaction
Periodo de tiempo: Baseline, 3 months, and 6 months
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Overall life satisfaction will be assessed using the Satisfaction With Life Scale.
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Baseline, 3 months, and 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Investigador principal: Chunxia Cheng, The Third XIANGYA Hospital of Central South University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de agosto de 2026
Finalización primaria (Estimado)
30 de agosto de 2028
Finalización del estudio (Estimado)
30 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
8 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de agosto de 2026
Publicado por primera vez (Actual)
13 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 2025JK2117
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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