NCT06848491Recruiting
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)
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 21 Feb 2025
- Start date
- 27 Oct 2025
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Obesity
- NCT number
- NCT06848491
What you commit to
- Study type: Interventional
- Planned participants: 240
- From 27 Oct 2025 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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 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
- Plans for major surgery (e.g., breast reconstruction) in the next 12 months
Other illness
- 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.
- 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
Other
- Lost 5% or more of body weight (and kept it off) in the last 3 months
- Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 12 months
- Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 39 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.