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

Recruiting now · Not applicable

Conditions studied: Obesity, Cancer, Physical Activity, Cancer Survivorship, Diet

In brief

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 facts

Study ID: NCT06848491
Run by: UNC Lineberger Comprehensive Cancer Center
People needed: 240
Starts: 2025-10-27
Expected to finish: 2028-10-31
Last updated by the study team: 2026-03-23

Who can join

Age: 18 and older, up to 39. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 it is running

University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.