Actively Recruiting
Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors (AYA Well)
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-03-23
240
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
V
Virginia Commonwealth University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates weight management strategies tailored for adolescent and young adult cancer survivors aged 18 to 39 years who have completed cancer treatment at least six months ago and have overweight or obesity. It compares a personalized, theory-based mobile health (mHealth) intervention with a self-guided program, aiming to assess their effects on weight change and related health outcomes over 12 months. The study focuses on improving motivation and behavior through digital tools and peer support tailored to this population. Participants are randomly assigned to one of two groups. The intervention group receives a comprehensive mHealth program including personalized nutrition and exercise goals, behavioral skills training via a mobile web app, digital self-monitoring tools like a smart scale and activity tracker, text messaging, and access to a moderated social networking group. The self-guided group uses similar digital tools, receives health education and newsletters, and participates in a peer support group without active prompts from study staff. The intervention lasts six months followed by six months of peer support only. During the study, participants complete assessments at baseline, 3, 6, and 12 months. These include remote weight measurements via smart scales, physical activity tracking with Fitbit devices, dietary intake surveys, and quality of life questionnaires. A subset will attend in-person visits to measure body composition, waist circumference, frailty, and biomarkers related to aging and heart health. The main measurement is the percent weight change at six months, with ongoing monitoring through 12 months to evaluate weight maintenance and other health indicators.
CONDITIONS
Brief Title
Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18-39 years old at the time of consent
- Diagnosed with first invasive cancer between ages 15-39 years
- Within 10 years of diagnosis with no evidence of progressive disease or second primary cancers
- Completed active cancer therapy at least six months prior to enrollment; may be on maintenance therapy
- Body mass index (BMI) between 25 and 50 kg/m2
You will not qualify if you...
- Type 1 diabetes or certain medical treatments for Type 2 diabetes
- History of heart attack or stroke within the past 6 months
- Health issues preventing walking or physical activity (e.g., lower limb amputation)
- Positive responses to physical activity readiness questions about heart problems, chest pain, faintness, or dizziness
- Lost 5% or more body weight and maintained loss in last 3 months
- History or recent behaviors related to eating disorders
- Currently pregnant, recently pregnant, or planning pregnancy within 12 months
- Untreated thyroid disease or recent thyroid medication changes
- Hospitalized for depression or other psychiatric disorders within past 12 months
- History of psychotic disorder or uncontrolled bipolar disorder
- Participation in other weight, nutrition, or physical activity studies
- Use of prescription medications affecting weight or appetite, except stable SSRIs
- Previous or planned weight loss surgery within next year
- Inability to speak or read English
- Does not reside in the United States
- No mobile phone with data plan or unwilling to receive texts
- No internet access
- Not willing to be randomized to either study arm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment and baseline data collection
Duration - 6 months
Participants receive a 6-month behavioral weight management intervention or self-guided support with digital tools, education, and peer support.
Assessments at 0, 3, and 6 months; daily engagement encouraged for intervention participants
Duration - 6 months
Participants continue with a 6-month maintenance phase with peer support.
Assessment at 12 months; ongoing peer support via social networking group
Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
Research Team
M
Molly Diamond, MPH
K
Karen E. Hatley, MPH, RD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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