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 — BEHAVIORAL
    Behavioral 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 — BEHAVIORAL
    Self-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: Intervention
    Intervention 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-Guided
    Self-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

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27514
Karen Hatley E Research Project Manager, MPH, RD, LDN
919-966-5853
Molly Diamond Research Associate, MPH

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