Couple-Coordinated Lifestyle Intervention for Women With a History of Gestational Diabetes Mellitus
8 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
362
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Hunan
-
Changde, Hunan, Kina, 415003
- Changde First People's Hospital
-
Kontakt:
- Jing Zhang
- Telefonnummer: 86 13873614102
- E-post: zhang.jing254x@163.com
-
Changsha, Hunan, Kina, 410004
- Changsha Central Hospital
-
Kontakt:
- Tao Liu
- Telefonnummer: 86 18173164259
- E-post: 92094418@qq.com
-
Huaihua, Hunan, Kina, 418000
- General Hospital of Hunan University of Medicine
-
Kontakt:
- Fuyan Tan
- Telefonnummer: 86 15115154712
- E-post: 328407894@qq.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Aktiv komparator: 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).
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
2 h Oral Glucose Tolerance Test
Tidsram: 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.
|
Baseline and 6 months
|
|
Body Mass Index
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Fasting Blood Glucose
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
|
Waist Circumference
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
|
Depression
Tidsram: Baseline, 3 months, and 6 months
|
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire.
|
Baseline, 3 months, and 6 months
|
|
Perceived Stress
Tidsram: Baseline, 3 months, and 6 months
|
Perceived stress will be assessed using the Perceived Stress Scale.
|
Baseline, 3 months, and 6 months
|
|
Dietary Self-Efficacy
Tidsram: 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
|
|
Exercise Self-Efficacy
Tidsram: 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
Tidsram: Baseline, 3 months, and 6 months
|
Couple Relationship Quality will be assessed using the Marital Satisfaction Subscale.
|
Baseline, 3 months, and 6 months
|
|
Dyadic Coping Ability
Tidsram: Baseline, 3 months, and 6 months
|
Dyadic Coping Ability will be assessed using the Dyadic Coping Scale.
|
Baseline, 3 months, and 6 months
|
|
Life Satisfaction
Tidsram: Baseline, 3 months, and 6 months
|
Overall life satisfaction will be assessed using the Satisfaction With Life Scale.
|
Baseline, 3 months, and 6 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Chunxia Cheng, The Third XIANGYA Hospital of Central South University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
15 augusti 2026
Primärt slutförande (Beräknad)
30 augusti 2028
Avslutad studie (Beräknad)
30 augusti 2028
Studieregistreringsdatum
Först inskickad
8 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
8 augusti 2026
Första postat (Faktisk)
13 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2025JK2117
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .