Couple-Coordinated Lifestyle Intervention for Women With a History of Gestational Diabetes Mellitus
2026年8月8日 更新者：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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
362
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Hunan
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Changde、Hunan、中国、415003
- Changde First People's Hospital
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コンタクト：
- Jing Zhang
- 電話番号：86 13873614102
- メール：zhang.jing254x@163.com
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Changsha、Hunan、中国、410004
- Changsha Central Hospital
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コンタクト：
- Tao Liu
- 電話番号：86 18173164259
- メール：92094418@qq.com
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Huaihua、Hunan、中国、418000
- General Hospital of Hunan University of Medicine
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コンタクト：
- Fuyan Tan
- 電話番号：86 15115154712
- メール：328407894@qq.com
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
2 h Oral Glucose Tolerance Test
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Fasting Blood Glucose
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Chunxia Cheng、The Third XIANGYA Hospital of Central South University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月15日
一次修了 (推定)
2028年8月30日
研究の完了 (推定)
2028年8月30日
試験登録日
最初に提出
2026年8月8日
QC基準を満たした最初の提出物
2026年8月8日
最初の投稿 (実際)
2026年8月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月13日
QC基準を満たした最後の更新が送信されました
2026年8月8日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2025JK2117
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