Couple-Coordinated Lifestyle Intervention for Women With a History of Gestational Diabetes Mellitus
2026년 8월 8일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
362
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Hunan
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Changde, Hunan, 중국, 415003
- Changde First People's Hospital
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연락하다:
- Jing Zhang
- 전화번호: 86 13873614102
- 이메일: zhang.jing254x@163.com
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Changsha, Hunan, 중국, 410004
- Changsha Central Hospital
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연락하다:
- Tao Liu
- 전화번호: 86 18173164259
- 이메일: 92094418@qq.com
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Huaihua, Hunan, 중국, 418000
- General Hospital of Hunan University of Medicine
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연락하다:
- Fuyan Tan
- 전화번호: 86 15115154712
- 이메일: 328407894@qq.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
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활성 비교기: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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2 h Oral Glucose Tolerance Test
기간: Baseline and 6 months
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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
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fasting Blood Glucose
기간: Baseline and 6 months
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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
기간: Baseline and 6 months
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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
기간: Baseline and 6 months
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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
기간: Baseline and 6 months
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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
기간: Baseline and 6 months
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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
기간: Baseline, 3 months, and 6 months
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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
기간: Baseline, 3 months, and 6 months
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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
기간: Baseline, 3 months, and 6 months
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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
기간: 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
기간: Baseline, 3 months, and 6 months
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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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Chunxia Cheng, The Third XIANGYA Hospital of Central South University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 15일
기본 완료 (추정된)
2028년 8월 30일
연구 완료 (추정된)
2028년 8월 30일
연구 등록 날짜
최초 제출
2026년 8월 8일
QC 기준을 충족하는 최초 제출
2026년 8월 8일
처음 게시됨 (실제)
2026년 8월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 8일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2025JK2117
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