Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors
Part of paid clinical trials in Chapel Hill, North Carolina.
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Study ID
- NCT06848491
- Status
- Recruiting
Conditions
- Cancer
- Cancer Survivorship
- Diet
- Obesity
- Physical Activity
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 39 Years
- Healthy Volunteers
- Not accepted
Interventions
- AYA WELL Intervention — BEHAVIORALBehavioral weight management intervention for adolescent and young adult cancer survivors with digital tools, smartphone web app behavioral program, text messages, and expert-guided closed social networking group for peer support.
- Self-Guided — BEHAVIORALSelf-guided intervention with digital tools, periodic informational support, and moderated social networking group for peer support.
Study Details
The AYA WELL study is a 2-arm randomized clinical trial to test the efficacy of a theory-based, mHealth weight management intervention adapted specifically for adolescent and young adult cancer survivors compared to a self-guided arm. Participants, diagnosed with cancer between ages 15-39, currently age 18-39, post-treatment at least 6 months, and who have overweight or obesity will be randomized to receive either: 1) a comprehensive mHealth weight management program (intervention) or 2) digital tools + health education + peer support (self-guided) over 12 months. Outcomes will be assessed at 3, 6, and 12 months.
Key Dates
- Start date
- Oct 27, 2025
- Status verified
- Mar 2026
- Primary completion
- Apr 30, 2028
- Completion
- Oct 31, 2028
Study Design
- Enrollment
- 240 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: InterventionIntervention participants will receive a theory-based mHealth intervention that includes personalized nutrition and physical activity goals, psychoeducation, and evidence-based behavioral skills training delivered via a mobile web app with active content during the first 6 months, provision of digital tools to facilitate self-monitoring (a smart scale and physical activity tracker), an individual video kick-off session, text messages, and access to a closed social networking group with moderated prompts from study staff to foster peer support. Participants are encouraged to log in to web app daily to interact with self-monitoring and behavioral guidance instruction, activities, and feedback.
- Active Comparator: Self-GuidedSelf-guided participants will receive digital tools (a smart scale and activity tracker), an individual video kick-off session, quarterly informational newsletters, and a moderated but non-prompted (by study staff) closed social networking group to enable peer support.
Primary Outcome Measure
Weight change percent [ Time Frame: Baseline to 6 months ]
Central Contacts
- Molly Diamond, MPH919-966-5852
- Karen E. Hatley, MPH, RD919-966-5853
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | Molly Diamond Research Associate, MPH |
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