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

8 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

362

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: 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).
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
2 h Oral Glucose Tolerance Test
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fasting Blood Glucose
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, 3 months, and 6 months
Overall life satisfaction will be assessed using the Satisfaction With Life Scale.
Baseline, 3 months, and 6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Third Xiangya Hospital of Central South University

Collaboratori

Central South University

Investigatori

  • Investigatore principale: Chunxia Cheng, The Third XIANGYA Hospital of Central South University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 agosto 2026

Completamento primario (Stimato)

30 agosto 2028

Completamento dello studio (Stimato)

30 agosto 2028

Date di iscrizione allo studio

Primo inviato

8 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 agosto 2026

Primo Inserito (Effettivo)

13 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2025JK2117

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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