Recruiting

mHealth Weight Management

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06848491

Conditions

Obesity

Cancer

Physical Activity

Cancer Survivorship

Diet

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Interventions

AYA WELL Intervention

Self-Guided

Study Details

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.

Conditions

Obesity

Cancer

Physical Activity

Cancer Survivorship

Diet

Study ID

NCT06848491

Start date

Oct 27, 2025

Status verified date

Aug, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not 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. 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
  • Plans for major surgery (e.g., breast reconstruction) in the next 12 months
  • 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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

Intervention 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.

active comparator: Self-Guided

Self-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

AYA WELL Intervention

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

Self-guided intervention with digital tools, periodic informational support, and moderated social networking group for peer support.

Primary outcome measure

  • Weight change percent [ Time Frame: Baseline to 6 months ]

Central Contacts and Locations

Central contacts

Molly Diamond, MPH

919-966-5852mdiamond@unc.edu

Karen E. Hatley, MPH, RD

919-966-5853keericks@email.unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Karen Hatley E Research Project Manager, MPH, RD, LDN

919-966-5853keericks@email.unc.edu

Molly Diamond Research Associate, MPH

mdiamond@unc.edu

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-08-24.