Diabetes PreventionNCT07762625
Couple-Coordinated Lifestyle Intervention for Women With a History of Gestational Diabetes Mellitus
A study testing Couple-based Collaborative Lifestyle Intervention and Woman-only Lifestyle Intervention in people with Diabetes Prevention and GDM, run by The Third Xiangya Hospital of Central South University at 3 sites in China.
Trial summary
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?… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Prevention, GDM, Lifestyle Intervention
- What is being tested?
- Couple-based Collaborative Lifestyle Intervention and Woman-only Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 3 sitesChina
- Study dates
- 15 Aug 2026to 30 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Changde First People's Hospital
Changde, Hunan, 415003
Jing Zhang, 86 13873614102, zhang.jing254x@163.com
Changsha Central Hospital
Changsha, Hunan, 410004
Tao Liu, 86 18173164259, 92094418@qq.com
General Hospital of Hunan University of Medicine
Huaihua, Hunan, 418000
Fuyan Tan, 86 15115154712, 328407894@qq.com
About this study
Official title: 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?
Read more
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.
- Conditions
- Diabetes Prevention, GDM, Lifestyle Intervention, Couples, Postpartum
- Being tested
- Couple-based Collaborative Lifestyle Intervention, Woman-only Lifestyle Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couple-based Collaborative Lifestyle InterventionBehavioural
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.
Woman-only Lifestyle InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Couple-based Collaborative Lifestyle Intervention arm | Experimental | 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. Receives: Behavioral: Couple-based Collaborative Lifestyle Intervention |
| Woman-only Lifestyle Intervention arm | Active comparator | 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). Receives: Behavioral: Woman-only Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 h Oral Glucose Tolerance Test
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.
Measured: Baseline and 6 months
Body Mass Index
Body mass index will be calculated as weight in kilograms divided by height in meters squared (kg/m²).
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (16)
Fasting Blood Glucose
Fasting blood glucose will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
Measured: Baseline and 6 months
Total Cholesterol
Total cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
Measured: Baseline and 6 months
Triglycerides
Triglycerides will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
Measured: Baseline and 6 months
High-Density Lipoprotein Cholesterol
High-density lipoprotein cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
Measured: Baseline and 6 months
Low-Density Lipoprotein Cholesterol
Low-density lipoprotein cholesterol will be measured from venous blood samples after an overnight fast and expressed in mmol/L.
Measured: Baseline and 6 months
Waist Circumference
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.
Measured: Baseline, 3 months, and 6 months
Composite Z Score for Healthy Lifestyle Behavior
A composite healthy lifestyle behavior score will be calculated by standardizing behavior measures into Z scores.
Measured: Baseline, 3 months, and 6 months
Diabetes Risk-Related Eating Behavior
Diabetes risk-related eating behaviors will be assessed using the Diabetes Risk-Related Eating Behavior Scale.
Measured: Baseline, 3 months, and 6 months
Physical Activity
Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form.
Measured: Baseline, 3 months, and 6 months
Depression
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire.
Measured: Baseline, 3 months, and 6 months
Perceived Stress
Perceived stress will be assessed using the Perceived Stress Scale.
Measured: Baseline, 3 months, and 6 months
Dietary Self-Efficacy
Confidence in adopting and maintaining healthy dietary behaviors will be assessed using the Dietary Self-Efficacy Scale.
Measured: Baseline, 3 months, and 6 months
Exercise Self-Efficacy
Confidence in engaging in and maintaining physical activity will be assessed using the Exercise Self-Efficacy Scale.
Measured: Baseline, 3 months, and 6 months
Couple Relationship Quality
Couple Relationship Quality will be assessed using the Marital Satisfaction Subscale.
Measured: Baseline, 3 months, and 6 months
Dyadic Coping Ability
Dyadic Coping Ability will be assessed using the Dyadic Coping Scale.
Measured: Baseline, 3 months, and 6 months
Life Satisfaction
Overall life satisfaction will be assessed using the Satisfaction With Life Scale.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes PreventionStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Central South University
- Responsible party
- Principal investigator, Cheng chunxia, The Third Xiangya Hospital of Central South University
- Investigators
- Chunxia Cheng, Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762625
- Sponsor's protocol ID
- 2025JK2117
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Couple-Coordinated Lifestyle Intervention Among Women With a History of Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07762625
- Acronym / sponsor ID
- 2025JK2117
- Conditions
- Diabetes Prevention, GDM, Lifestyle Intervention, Couples, Postpartum
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Central South University
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couple-based Collaborative Lifestyle Intervention arm | Experimental | Behavioral: Couple-based Collaborative Lifestyle InterventionWomen 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. |
| Woman-only Lifestyle Intervention arm | Active comparator | Behavioral: Woman-only Lifestyle InterventionWomen 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). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- For women:
- For spouses:
Key exclusion criteria (12 listed)
- For women:
- For spouses:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couple-based Collaborative Lifestyle InterventionCouples 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. | Behavioural | Couple-based Collaborative Lifestyle Intervention arm |
| Woman-only Lifestyle InterventionWomen 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. | Behavioural | Woman-only Lifestyle Intervention arm |
Primary outcome
2 h Oral Glucose Tolerance Test
Time frame: 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.
Body Mass Index
Time frame: Baseline, 3 months, and 6 months
Body mass index will be calculated as weight in kilograms divided by height in meters squared (kg/m²).
16 secondary outcomes
Fasting Blood Glucose
Time frame: Baseline and 6 months
Total Cholesterol
Time frame: Baseline and 6 months
Triglycerides
Time frame: Baseline and 6 months
High-Density Lipoprotein Cholesterol
Time frame: Baseline and 6 months
Low-Density Lipoprotein Cholesterol
Time frame: Baseline and 6 months
Waist Circumference
Time frame: Baseline, 3 months, and 6 months
Composite Z Score for Healthy Lifestyle Behavior
Time frame: Baseline, 3 months, and 6 months
Diabetes Risk-Related Eating Behavior
Time frame: Baseline, 3 months, and 6 months
Physical Activity
Time frame: Baseline, 3 months, and 6 months
Depression
Time frame: Baseline, 3 months, and 6 months
Perceived Stress
Time frame: Baseline, 3 months, and 6 months
Dietary Self-Efficacy
Time frame: Baseline, 3 months, and 6 months
Exercise Self-Efficacy
Time frame: Baseline, 3 months, and 6 months
Couple Relationship Quality
Time frame: Baseline, 3 months, and 6 months
Dyadic Coping Ability
Time frame: Baseline, 3 months, and 6 months
Life Satisfaction
Time frame: Baseline, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chunxia Cheng principal investigator
The Third Xiangya Hospital of Central South University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couple-based Collaborative Lifestyle Intervention and Woman-only Lifestyle Intervention in people with Diabetes Prevention and GDM, run by The Third Xiangya Hospital of Central South University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 h Oral Glucose Tolerance Test (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.