Couple-Coordinated Lifestyle Intervention for Women With a History of Gestational Diabetes Mellitus
8 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Studietype
Ingrijpend
Inschrijving (Geschat)
362
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Hunan
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Changde, Hunan, China, 415003
- Changde First People's Hospital
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Contact:
- Jing Zhang
- Telefoonnummer: 86 13873614102
- E-mail: zhang.jing254x@163.com
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Changsha, Hunan, China, 410004
- Changsha Central Hospital
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Contact:
- Tao Liu
- Telefoonnummer: 86 18173164259
- E-mail: 92094418@qq.com
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Huaihua, Hunan, China, 418000
- General Hospital of Hunan University of Medicine
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Contact:
- Fuyan Tan
- Telefoonnummer: 86 15115154712
- E-mail: 328407894@qq.com
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Actieve vergelijker: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
2 h Oral Glucose Tolerance Test
Tijdsspanne: 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
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Body Mass Index
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Fasting Blood Glucose
Tijdsspanne: Baseline and 6 months
|
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
Tijdsspanne: Baseline and 6 months
|
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
Tijdsspanne: Baseline and 6 months
|
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
Tijdsspanne: Baseline and 6 months
|
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
Tijdsspanne: Baseline and 6 months
|
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
Tijdsspanne: 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.
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Baseline, 3 months, and 6 months
|
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Composite Z Score for Healthy Lifestyle Behavior
Tijdsspanne: 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
|
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Diabetes Risk-Related Eating Behavior
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, 3 months, and 6 months
|
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Chunxia Cheng, The Third XIANGYA Hospital of Central South University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
15 augustus 2026
Primaire voltooiing (Geschat)
30 augustus 2028
Studie voltooiing (Geschat)
30 augustus 2028
Studieregistratiedata
Eerst ingediend
8 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
8 augustus 2026
Eerst geplaatst (Werkelijk)
13 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
8 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 2025JK2117
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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