Personalized mobile weight-management program for adolescent and young adult cancer survivors
Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors (AYA Well)
This trial will test whether a personalized mobile health program helps cancer survivors ages 18–39 with overweight or obesity lose more weight over six months than a self-guided digital program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06848491 on ClinicalTrials.gov |
What this trial studies
AYA WELL is a randomized, two-arm trial enrolling 240 adolescent and young adult cancer survivors (current age 18–39) with BMI 25–50 kg/m2 who completed active treatment at least six months earlier. Participants are randomized to a 6-month theory-based mHealth intervention (personalized nutrition and activity goals, smart scale and activity tracker, tailored feedback, texts, behavioral skills training, and a closed peer support group) or to a self-guided arm that receives digital tools, health education, and peer support. The active intervention is followed by a 6-month maintenance phase with peer support only, and assessments occur at baseline, 3, 6, and 12 months. The primary outcome is percent weight change at 6 months measured remotely using provided devices.
Who should consider this trial
Good fit: Ideal candidates are adults 18–39 who were first diagnosed with invasive cancer between ages 15–39, are within 10 years of diagnosis with no active progressive disease, finished active cancer therapy at least six months ago, and have a BMI between 25 and 50 kg/m2.
Not a fit: Patients with type 1 diabetes or certain diabetes treatments, recent major cardiac events, severe mobility limitations that prevent walking, or other medical exclusions may not benefit from or be eligible for the intervention.
Why it matters
Potential benefit: If successful, the program could help AYA cancer survivors with overweight or obesity achieve clinically meaningful weight loss and improve diet and physical activity.
How similar studies have performed: Similar mHealth weight-management programs have produced small-to-moderate weight loss in general and adult cancer populations, but AYA-focused, tailored trials remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Type 1 diabetes or currently receiving certain medical treatments for Type 2 diabetes * Report a history of heart attack or stroke within previous 6 months * Health problems which preclude ability to walk for physical activity (e.g., lower limb amputation). Participants endorsing items 1-4 on the Physical Activity Readiness Questionnaire (PAR-Q) (experience of heart problems, frequent chest pains, or faintness or dizziness) will be excluded from the study. * Lost 5% or more of body weight (and kept it off) in the last 3 months * Lifetime history of clinical diagnosis or treatment of eating disorder (anorexia nervosa or bulimia nervosa), OR report of compensatory behaviors within the previous 3 months. If participant reports a history of compensatory behaviors, the investigators will review their information to determine eligibility. * Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 12 months * Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months * Hospitalization for depression or other psychiatric disorder within the past 12 months. * History of psychotic disorder or uncontrolled bipolar disorder * Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study * Currently using prescription medications with known effects on appetite or weight (e.g., oral steroids, weight loss medications), with the exception of individuals on a stable dose of SSRIs for 3 months) * Previous surgical procedure for weight loss or planned weight loss surgery in the next year * Inability to speak and read English * Does not reside in the United States * Do not have mobile phone with data plan or willing to be contacted by study through text messaging * No Internet access * Not willing to be randomized to either intervention arm
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Carmina G. Valle, PhD, MPH — University of North Carolina, Chapel Hill
- Study coordinator: Molly Diamond, MPH
- Email: mdiamond@unc.edu
- Phone: 919-966-5852
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.