NCT06848491 Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors
| NCT ID | NCT06848491 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2025-10-27 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Carmina G. Valle, PhD, MPH
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06848491 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 39 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06848491 currently recruiting?
Yes, NCT06848491 is actively recruiting participants. Contact the research team at mdiamond@unc.edu for enrollment information.
Where is the NCT06848491 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06848491 clinical trial?
NCT06848491 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Carmina G. Valle, PhD, MPH at University of North Carolina, Chapel Hill. The trial plans to enroll 240 participants.
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