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

RECRUITINGN/ASponsored by UNC Lineberger Comprehensive Cancer Center
Actively Recruiting
PhaseN/A
SponsorUNC Lineberger Comprehensive Cancer Center
Started2025-10-27
Est. completion2028-04-30
Eligibility
Age18 Years – 39 Years
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years – 39 YearsHealthy volunteers accepted
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
* 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

Conditions5

CancerCancer SurvivorshipDietObesityPhysical Activity

Locations1 site

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Karen Hatley E Research Project Manager, MPH, RD, LDN919-966-5853keericks@email.unc.edu

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