Couple-Coordinated Lifestyle Intervention for Women With a History of Gestational Diabetes Mellitus
8. august 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Studietype
Intervensjonell
Registrering (Antatt)
362
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Hunan
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Changde, Hunan, Kina, 415003
- Changde First People's Hospital
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Ta kontakt med:
- Jing Zhang
- Telefonnummer: 86 13873614102
- E-post: zhang.jing254x@163.com
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Changsha, Hunan, Kina, 410004
- Changsha Central Hospital
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Ta kontakt med:
- Tao Liu
- Telefonnummer: 86 18173164259
- E-post: 92094418@qq.com
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Huaihua, Hunan, Kina, 418000
- General Hospital of Hunan University of Medicine
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Ta kontakt med:
- Fuyan Tan
- Telefonnummer: 86 15115154712
- E-post: 328407894@qq.com
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
2 h Oral Glucose Tolerance Test
Tidsramme: 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
Tidsramme: 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).
|
Baseline, 3 months, and 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fasting Blood Glucose
Tidsramme: 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
|
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Total Cholesterol
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
|
Composite Z Score for Healthy Lifestyle Behavior
Tidsramme: Baseline, 3 months, and 6 months
|
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
Tidsramme: 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
|
|
Physical Activity
Tidsramme: Baseline, 3 months, and 6 months
|
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
Tidsramme: 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
Tidsramme: Baseline, 3 months, and 6 months
|
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
Tidsramme: Baseline, 3 months, and 6 months
|
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
Tidsramme: Baseline, 3 months, and 6 months
|
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
Tidsramme: Baseline, 3 months, and 6 months
|
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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Chunxia Cheng, The Third XIANGYA Hospital of Central South University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
15. august 2026
Primær fullføring (Antatt)
30. august 2028
Studiet fullført (Antatt)
30. august 2028
Datoer for studieregistrering
Først innsendt
8. august 2026
Først innsendt som oppfylte QC-kriteriene
8. august 2026
Først lagt ut (Faktiske)
13. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2025JK2117
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