Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-28 @ 12:56 PM
Study NCT ID:
NCT06966661
Status:
COMPLETED
Last Update Posted:
2025-05-13
First Post:
2025-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peer-Supported E-Health Intervention for College Student Weight Management and Mental Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-04', 'studyFirstSubmitDate': '2025-05-04', 'studyFirstSubmitQcDate': '2025-05-04', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Weight', 'timeFrame': 'Baseline and Month 6 (6 months)', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Change in Depression Severity (PHQ-9)', 'timeFrame': 'Baseline and Month 6 (6 months)', 'description': 'Mean change in Patient Health Questionnaire-9 (PHQ-9) total score from baseline to the end of the 6-month intervention, assessed via standardized self-administered questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression - Major Depressive Disorder', 'Psychological Well Being', 'Obesity Prevention']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full-time undergraduate students aged 18-25 years\n* Baseline BMI ≥ 24.0 kg/m²\n* Able to provide informed consent\n* Owns a smartphone or computer with internet access\n* Willing to attend monthly lectures and complete online modules\n\nExclusion Criteria:\n\n* Current participation in another weight-management or psychological intervention program\n* Diagnosis of an eating disorder, severe psychiatric illness, or medical condition affecting weight (e.g., hyperthyroidism)\n* Pregnant or planning pregnancy during the study period\n* Any physical limitation precluding participation in light-to-moderate physical activity\n* Inability to communicate in the language of intervention materials'}, 'identificationModule': {'nctId': 'NCT06966661', 'briefTitle': 'Peer-Supported E-Health Intervention for College Student Weight Management and Mental Health', 'organization': {'class': 'OTHER', 'fullName': 'Jinan University Guangzhou'}, 'officialTitle': 'Peer-Supported E-Health Intervention for College Student Weight Management and Mental Health', 'orgStudyIdInfo': {'id': '2025LCLL-057'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Arm'}, {'type': 'EXPERIMENTAL', 'label': 'Peer Support Arm', 'interventionNames': ['Behavioral: Peer Support Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Peer Support eHealth Arm', 'interventionNames': ['Behavioral: Peer Support and eHealth Intervention']}], 'interventions': [{'name': 'Peer Support Intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Peer Support Arm']}, {'name': 'Peer Support and eHealth Intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Peer Support eHealth Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'New Territories', 'country': 'China', 'facility': 'School of Physical Education, Jinan University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinan University Guangzhou', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guangzhou Sport University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer, School of Physical Education, Jinan University', 'investigatorFullName': 'Ma Ruisi', 'investigatorAffiliation': 'Jinan University Guangzhou'}}}}