Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors
AYAWell
2 other identifiers
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Oct 2025
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2025
CompletedFirst Posted
Study publicly available on registry
February 27, 2025
CompletedStudy Start
First participant enrolled
October 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2028
March 23, 2026
March 1, 2026
2.5 years
February 21, 2025
March 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Weight change percent
Change in weight (%) from baseline to 6 months. Weight will be objectively measured on a digital scale in the participant's home for remote participants and in the clinic for in person assessments. Percent weight change at 6 months is calculated as ((weight (kg) at 6 months - weight (kg) at baseline)/(weight (kg) at baseline))\*100.
Baseline to 6 months
Secondary Outcomes (14)
Weight maintenance percent
6 to 12 months
Body Mass Index (BMI)
Baseline up to 12 months
Health-related quality of life
Baseline up to 12 months
Diet quality
Baseline up to 12 months
Device-measured physical activity
Baseline up to 12 months
- +9 more secondary outcomes
Other Outcomes (8)
Depressive Symptoms
Baseline up to 12 months
Perceived Stress
Baseline up to 12 months
Anxiety
Baseline up to 12 months
- +5 more other outcomes
Study Arms (2)
Intervention
EXPERIMENTALIntervention participants will receive a theory-based mHealth intervention that includes personalized nutrition and physical activity goals, psychoeducation, and evidence-based behavioral skills training delivered via a mobile web app with active content during the first 6 months, provision of digital tools to facilitate self-monitoring (a smart scale and physical activity tracker), an individual video kick-off session, text messages, and access to a closed social networking group with moderated prompts from study staff to foster peer support. Participants are encouraged to log in to web app daily to interact with self-monitoring and behavioral guidance instruction, activities, and feedback.
Self-Guided
ACTIVE COMPARATORSelf-guided participants will receive digital tools (a smart scale and activity tracker), an individual video kick-off session, quarterly informational newsletters, and a moderated but non-prompted (by study staff) closed social networking group to enable peer support.
Interventions
Behavioral weight management intervention for adolescent and young adult cancer survivors with digital tools, smartphone web app behavioral program, text messages, and expert-guided closed social networking group for peer support.
Self-guided intervention with digital tools, periodic informational support, and moderated social networking group for peer support.
Eligibility Criteria
You may qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNC Lineberger Comprehensive Cancer Centerlead
- Virginia Commonwealth Universitycollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carmina G. Valle, PhD, MPH
University of North Carolina, Chapel Hill
- PRINCIPAL INVESTIGATOR
Jessica Gokee LaRose, PhD
Virginia Commonwealth University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2025
First Posted
February 27, 2025
Study Start
October 27, 2025
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
October 31, 2028
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- beginning at 12 and continuing for 36 months following publication
- Access Criteria
- Investigator has UNC PI-approved proposal, institutional IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC
Any data sharing will be under the auspices of UNC-approved data-sharing agreements with investigators wishing to use the data. Specific requests will provide a limited dataset to prospective investigators after any data-cleaning prior to sharing. Potential investigators will submit a request to the Contact PI (Valle) that includes hypotheses, variables needed, and plans for disseminating findings. Final research data analyzed for publication of main trial findings as specified in our specific aims will be made available no later than acceptance of data for publication. Any publication will be embargoed per the journal's requirements or regulations and will be made publicly available no later than 12 months after the official date of publication in accordance with NIH Public Access Policy. The release of specific data may be delayed if data are part of an analysis being prepared for a separate publication.