Couple-Coordinated Lifestyle Intervention for Women With a History of Gestational Diabetes Mellitus
8 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Type d'étude
Interventionnel
Inscription (Estimé)
362
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Hunan
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Changde, Hunan, Chine, 415003
- Changde First People's Hospital
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Contact:
- Jing Zhang
- Numéro de téléphone: 86 13873614102
- E-mail: zhang.jing254x@163.com
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Changsha, Hunan, Chine, 410004
- Changsha Central Hospital
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Contact:
- Tao Liu
- Numéro de téléphone: 86 18173164259
- E-mail: 92094418@qq.com
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Huaihua, Hunan, Chine, 418000
- General Hospital of Hunan University of Medicine
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Contact:
- Fuyan Tan
- Numéro de téléphone: 86 15115154712
- E-mail: 328407894@qq.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
2 h Oral Glucose Tolerance Test
Délai: 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.
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Baseline and 6 months
|
|
Body Mass Index
Délai: Baseline, 3 months, and 6 months
|
Body mass index will be calculated as weight in kilograms divided by height in meters squared (kg/m²).
|
Baseline, 3 months, and 6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fasting Blood Glucose
Délai: Baseline and 6 months
|
Fasting blood glucose will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
|
Baseline and 6 months
|
|
Total Cholesterol
Délai: Baseline and 6 months
|
Total cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
|
Baseline and 6 months
|
|
Triglycerides
Délai: Baseline and 6 months
|
Triglycerides will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
|
Baseline and 6 months
|
|
High-Density Lipoprotein Cholesterol
Délai: Baseline and 6 months
|
High-density lipoprotein cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
|
Baseline and 6 months
|
|
Low-Density Lipoprotein Cholesterol
Délai: Baseline and 6 months
|
Low-density lipoprotein cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
|
Baseline and 6 months
|
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Waist Circumference
Délai: 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.
|
Baseline, 3 months, and 6 months
|
|
Composite Z Score for Healthy Lifestyle Behavior
Délai: Baseline, 3 months, and 6 months
|
A composite healthy lifestyle behavior score will be calculated by standardizing behavior measures into Z scores.
|
Baseline, 3 months, and 6 months
|
|
Diabetes Risk-Related Eating Behavior
Délai: Baseline, 3 months, and 6 months
|
Diabetes risk-related eating behaviors will be assessed using the Diabetes Risk-Related Eating Behavior Scale.
|
Baseline, 3 months, and 6 months
|
|
Physical Activity
Délai: Baseline, 3 months, and 6 months
|
Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form.
|
Baseline, 3 months, and 6 months
|
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Depression
Délai: Baseline, 3 months, and 6 months
|
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire.
|
Baseline, 3 months, and 6 months
|
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Perceived Stress
Délai: Baseline, 3 months, and 6 months
|
Perceived stress will be assessed using the Perceived Stress Scale.
|
Baseline, 3 months, and 6 months
|
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Dietary Self-Efficacy
Délai: Baseline, 3 months, and 6 months
|
Confidence in adopting and maintaining healthy dietary behaviors will be assessed using the Dietary Self-Efficacy Scale.
|
Baseline, 3 months, and 6 months
|
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Exercise Self-Efficacy
Délai: Baseline, 3 months, and 6 months
|
Confidence in engaging in and maintaining physical activity will be assessed using the Exercise Self-Efficacy Scale.
|
Baseline, 3 months, and 6 months
|
|
Couple Relationship Quality
Délai: Baseline, 3 months, and 6 months
|
Couple Relationship Quality will be assessed using the Marital Satisfaction Subscale.
|
Baseline, 3 months, and 6 months
|
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Dyadic Coping Ability
Délai: Baseline, 3 months, and 6 months
|
Dyadic Coping Ability will be assessed using the Dyadic Coping Scale.
|
Baseline, 3 months, and 6 months
|
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Life Satisfaction
Délai: Baseline, 3 months, and 6 months
|
Overall life satisfaction will be assessed using the Satisfaction With Life Scale.
|
Baseline, 3 months, and 6 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Chunxia Cheng, The Third XIANGYA Hospital of Central South University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
15 août 2026
Achèvement primaire (Estimé)
30 août 2028
Achèvement de l'étude (Estimé)
30 août 2028
Dates d'inscription aux études
Première soumission
8 août 2026
Première soumission répondant aux critères de contrôle qualité
8 août 2026
Première publication (Réel)
13 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2025JK2117
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .