NCT06848491

Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors

Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors (AYA Well)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

AYA WELL is a multi-site randomized clinical trial to test the efficacy of a 6-month theory-based, mHealth weight management intervention designed specifically for adolescent and young adult (AYA) cancer survivors, compared to a self-guided arm. The intervention is grounded in self-determination theory and designed to promote intrinsic motivation for behavior change by enhancing perceived competence, relatedness, and autonomy. The mHealth intervention includes personalized nutrition and physical activity goals, psychoeducation, evidence-based behavioral skills training, digital tools to facilitate self-monitoring (smart scale and activity tracker), tailored feedback, text messages, and access to a closed social networking group to foster peer support. The self-guided arm will receive digital tools, education, and a social networking group for peer support. The 6-month intervention will be followed by a 6-month maintenance phase (peer support only). AYA survivors (N=240, diagnosed between ages 15-39 \[current age 18-39\], posttreatment \>6 months, body mass index \[BMI\] 25-50 kg/m2) will be randomized to: 1) mHealth intervention or 2) self-guided (digital tools + education + peer support only). Randomization will be stratified by BMI, sex assigned at birth, and race/ethnicity. Assessments will occur at 0 (baseline), 3 (intervention mid-point), 6 (post-intervention), and 12 months (follow-up). Percent weight change at 6 months (primary outcome) will be assessed using a remote data collection protocol via fasted video weigh-in via smart scale to facilitate enhanced reach across the US. Secondary outcomes include frailty (frailty index), objectively measured physical activity (Fitbit), dietary intake (ASA24), and quality of life (SF-36), as well as validated surveys assessing hypothesized psychosocial mediators targeted by the intervention. A subsample of participants will complete in-person visits at each clinical site (UNC and VCU) at 0, 6, and 12 months to assess changes in body composition, waist circumference, frailty, and biomarkers of aging and cardiometabolic disease. Specific aims are: AIM 1: To test the efficacy of a theory-based, mHealth weight management intervention compared with a self-guided control arm on percent weight change among AYA cancer survivors. AIM 2: To determine the efficacy of the intervention compared to self-guided control on secondary outcomes. AIM 3: To examine whether changes in putative theoretical mechanisms (competence, relatedness, autonomy) mediate the effects of the intervention on weight change.

Conditions

• Obesity
• Cancer
• Physical Activity
• Cancer Survivorship
• Diet

Interventions

Type	Name	Description
BEHAVIORAL	AYA WELL Intervention	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.
BEHAVIORAL	Self-Guided	Self-guided intervention with digital tools, periodic informational support, and moderated social networking group for peer support.

Timeline

• Start date: 2025-10-27
• Primary completion: 2028-04-30
• Completion: 2028-10-31
• First posted: 2025-02-27
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States