Depression - Major Depressive DisorderNCT06966661
Peer-Supported E-Health Intervention for College Student Weight Management and Mental Health
A study testing Peer Support Intervention and Peer Support and eHealth Intervention in people with Depression - Major Depressive Disorder and Psychological Well Being, run by Jinan University Guangzhou at 1 site in China.
Trial summary
This study will test whether adding peer support and online education can help college students manage their weight and improve their mood: we plan to enroll 300 full-time university students and randomly assign them to one of three six-month groups (monthly in-person health talks and weekly emailed tips alone; those… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression - Major Depressive Disorder, Psychological Well Being, Obesity Prevention
- What is being tested?
- Peer Support Intervention and Peer Support and eHealth Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2024to 5 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full-time undergraduate students aged 18-25 years
- Baseline BMI ≥ 24.0 kg/m²
- Able to provide informed consent
- Owns a smartphone or computer with internet access
- Willing to attend monthly lectures and complete online modules
Who cannot join
- Current participation in another weight-management or psychological intervention program
- Diagnosis of an eating disorder, severe psychiatric illness, or medical condition affecting weight (e.g., hyperthyroidism)
- Pregnant or planning pregnancy during the study period
- Any physical limitation precluding participation in light-to-moderate physical activity
- Inability to communicate in the language of intervention materials
Trial locations and contacts
1 site in 1 country.
China1 site
School of Physical Education, Jinan University
Guangzhou, New Territories
About this study
This study will test whether adding peer support and online education can help college students manage their weight and improve their mood: we plan to enroll 300 full-time university students and randomly assign them to one of three six-month groups (monthly in-person health talks and weekly emailed tips alone; those activities plus biweekly peer-mentor meetings and an online chat group; or those activities plus a custom app delivering weekly lessons, monthly expert live Q\&A, and self-tracking tools). We will measure weight, body mass index (BMI), and scores on standard questionnaires for depression (PHQ-9), anxiety (GAD-7) and life satisfaction (SWLS) at baseline, three months and six months to compare the effectiveness of each approach. By identifying which combination of face-to-face support and digital tools produces the greatest improvements, we aim to inform low-cost, scalable programs to help students maintain a healthy weight and emotional well-being.
- Being tested
- Peer Support Intervention, Peer Support and eHealth Intervention
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Support InterventionBehavioural
In addition to all components of Standard Health Education, participants join biweekly, small-group meetings (6-8 peers) facilitated by trained upper-year student mentors who guide goal-setting, experience sharing, and mutual accountability. A moderated online chat forum provides daily encouragement, peer-to-peer Q\&A, and group reminders, distinguishing this arm by its structured social support network.
Peer Support and eHealth InterventionBehavioural
This arm integrates the full Peer Support Intervention with a custom mobile/web application that delivers weekly, interactive modules on nutrition, exercise, and mental health; offers in-app self-monitoring tools for weight, dietary intake, and mood; and hosts monthly live Q\&A webinars with clinical nutritionists and mental health professionals. The combination of real-time peer interaction and scalable digital content differentiates it as a multifaceted, blended-delivery intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Not described |
| Peer Support Arm | Experimental | Not described Receives: Behavioral: Peer Support Intervention |
| Peer Support eHealth Arm | Experimental | Not described Receives: Behavioral: Peer Support and eHealth Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Mean change in body weight (in kilograms) from baseline to the end of the 6-month intervention, measured by a calibrated digital scale under standardized conditions (light clothing, no shoes).
Measured: Baseline and Month 6 (6 months)
Secondary outcomes (1)
Change in Depression Severity (PHQ-9)
Mean change in Patient Health Questionnaire-9 (PHQ-9) total score from baseline to the end of the 6-month intervention. The PHQ-9 is a 9-item self-administered questionnaire used to monitor the severity of depression and response to treatment. The total score ranges from 0 to 27, where higher scores indicate greater depression severity (worse outcome).
Measured: Baseline and Month 6 (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 May 2025
- Study start2 Nov 2024
- Primary completion30 Apr 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinan University Guangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Sport University
- Responsible party
- Principal investigator, Ma Ruisi, Jinan University Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966661
- Sponsor's protocol ID
- 2025LCLL-057
- Status last verified
- Jan 2026
- First submitted
- 4 May 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The research team will conduct in-depth analyses of key scientific questions and will maintain an embargo period to secure publication priority and preserve the integrity of the study's findings; after this period, de-identified individual participant data will be made available to qualified researchers upon request.
Publications
Liu X, Liu T, Chen T, Ma R. Efficacy of a Digital Peer Support Program on Weight Management and Mental Health in University Students With Preobesity: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Jan 21;14:e78960. doi: 10.2196/78960.
PubMed 41564335
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-Supported E-Health Intervention for College Student Weight Management and Mental Health
- ClinicalTrials.gov ID
- NCT06966661
- Acronym / sponsor ID
- 2025LCLL-057
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Jinan University GuangzhouUniversity, hospital or other
- Collaborators
- Guangzhou Sport University
- Study start
- 2 Nov 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 13 May 2025 (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.
This study will test whether adding peer support and online education can help college students manage their weight and improve their mood: we plan to enroll 300 full-time university students and randomly assign them to one of three six-month groups (monthly in-person health talks and weekly emailed tips alone; those activities plus biweekly peer-mentor meetings and an online chat group; or those activities plus a custom app delivering weekly lessons, monthly expert live Q\&A, and self-tracking tools). We will measure weight, body mass index (BMI), and scores on standard questionnaires for depression (PHQ-9), anxiety (GAD-7) and life satisfaction (SWLS) at baseline, three months and six months to compare the effectiveness of each approach. By identifying which combination of face-to-face support and digital tools produces the greatest improvements, we aim to inform low-cost, scalable programs to help students maintain a healthy weight and emotional well-being.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | – |
| Peer Support Arm | Experimental | Behavioral: Peer Support Intervention |
| Peer Support eHealth Arm | Experimental | Behavioral: Peer Support and eHealth Intervention |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Full-time undergraduate students aged 18-25 years
- Baseline BMI ≥ 24.0 kg/m²
- Able to provide informed consent
- Owns a smartphone or computer with internet access
- Willing to attend monthly lectures and complete online modules
Key exclusion criteria (5 listed)
- Current participation in another weight-management or psychological intervention program
- Diagnosis of an eating disorder, severe psychiatric illness, or medical condition affecting weight (e.g., hyperthyroidism)
- Pregnant or planning pregnancy during the study period
- Any physical limitation precluding participation in light-to-moderate physical activity
- Inability to communicate in the language of intervention materials
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 |
|---|---|---|
| Peer Support InterventionIn addition to all components of Standard Health Education, participants join biweekly, small-group meetings (6-8 peers) facilitated by trained upper-year student mentors who guide goal-setting, experience sharing, and mutual accountability. A moderated online chat forum provides daily encouragement, peer-to-peer Q\&A, and group reminders, distinguishing this arm by its structured social support network. | Behavioural | Peer Support Arm |
| Peer Support and eHealth InterventionThis arm integrates the full Peer Support Intervention with a custom mobile/web application that delivers weekly, interactive modules on nutrition, exercise, and mental health; offers in-app self-monitoring tools for weight, dietary intake, and mood; and hosts monthly live Q\&A webinars with clinical nutritionists and mental health professionals. The combination of real-time peer interaction and scalable digital content differentiates it as a multifaceted, blended-delivery intervention. | Behavioural | Peer Support eHealth Arm |
Primary outcome
Change in Body Weight
Time frame: Baseline and Month 6 (6 months)
Mean change in body weight (in kilograms) from baseline to the end of the 6-month intervention, measured by a calibrated digital scale under standardized conditions (light clothing, no shoes).
1 secondary outcome
Change in Depression Severity (PHQ-9)
Time frame: Baseline and Month 6 (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Derived from this study: PubMed 41564335Liu X, Liu T, Chen T, Ma R. Efficacy of a Digital Peer Support Program on Weight Management and Mental Health in University Students With Preobesity: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Jan 21;14:e78960. doi: 10.2196/78960.
- Individual participant dataSharing planned: Undecided. The research team will conduct in-depth analyses of key scientific questions and will maintain an embargo period to secure publication priority and preserve the integrity of the study's findings; after this period, de-identified individual participant data will be made available to qualified researchers upon request.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Support Intervention and Peer Support and eHealth Intervention in people with Depression - Major Depressive Disorder and Psychological Well Being, run by Jinan University Guangzhou at 1 site 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: Baseline and Month 6 (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06966661, which also lists 1 linked publication.
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 8 Jan 2026.