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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 39
Healthy Volunteers: f
View:

• 18-39 years old at the time of consent.

• Diagnosed with first invasive cancer between ages 15-39 years (self-report).

• Within 10 years of diagnosis with no evidence of progressive disease or second primary cancers (self-report).

• Completed active cancer directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention) at least six months prior to enrollment; may be receiving maintenance therapy to prevent recurrences (self-report).

• Body mass index (BMI) of 25-50 kg/m2

Locations
United States
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Contact Information
Primary
Molly Diamond, MPH
mdiamond@unc.edu
919-966-5852
Backup
Karen E. Hatley, MPH, RD
keericks@email.unc.edu
919-966-5853
Time Frame
Start Date: 2025-10-27
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 240
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Virginia Commonwealth University, National Cancer Institute (NCI)
Leads: UNC Lineberger Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov