Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Couple-Coordinated Lifestyle Intervention for Women With a History of Gestational Diabetes Mellitus

8. august 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

362

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Hunan
      • Changde, Hunan, Kina, 415003
        • Changde First People's Hospital
        • Kontakt:
      • Changsha, Hunan, Kina, 410004
        • Changsha Central Hospital
        • Kontakt:
      • Huaihua, Hunan, Kina, 418000
        • General Hospital of Hunan University of Medicine
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. 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.

  2. 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:

  1. 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.

  2. 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Couple-based Collaborative Lifestyle Intervention
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).
Adfærdsmæssigt: Woman-only Lifestyle Intervention
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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.
Baseline and 6 months
Body Mass Index
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
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.
Baseline and 6 months
Triglycerides
Tidsramme: 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
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.
Baseline and 6 months
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
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.
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.
Baseline, 3 months, and 6 months
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.
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.
Baseline, 3 months, and 6 months
Depression
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, 3 months, and 6 months
Overall life satisfaction will be assessed using the Satisfaction With Life Scale.
Baseline, 3 months, and 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Third Xiangya Hospital of Central South University

Samarbejdspartnere

Central South University

Efterforskere

  • Ledende efterforsker: Chunxia Cheng, The Third XIANGYA Hospital of Central South University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. august 2026

Primær færdiggørelse (Anslået)

30. august 2028

Studieafslutning (Anslået)

30. august 2028

Datoer for studieregistrering

Først indsendt

8. august 2026

Først indsendt, der opfyldte QC-kriterier

8. august 2026

Først opslået (Faktiske)

13. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2025JK2117

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner