Clinical trial NCT06848491: Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors
Official title: Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors (AYA Well)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Cancer
Physical Activity
Cancer Survivorship
Diet
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Virginia Commonwealth University
name: National Cancer Institute (NCI)
First posted: 2025-02-27
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two conditions following baseline assessments in a 1:1 ratio. The conditions are Intervention or Self-Guided.
Primary purpose: TREATMENT

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.

Detailed description: AYA WELL is a multi-site randomized clinical trial to test the efficacy of a 6-month theory-based, mHealth weight management intervention designed specifically for adolescent and young adult (AYA) cancer survivors, compared to a self-guided arm. The intervention is grounded in self-determination theory and designed to promote intrinsic motivation for behavior change by enhancing perceived competence, relatedness, and autonomy. The mHealth intervention includes personalized nutrition and physical activity goals, psychoeducation, evidence-based behavioral skills training, digital tools to facilitate self-monitoring (smart scale and activity tracker), tailored feedback, text messages, and access to a closed social networking group to foster peer support. The self-guided arm will receive digital tools, education, and a social networking group for peer support. The 6-month intervention will be followed by a 6-month maintenance phase (peer support only). AYA survivors (N=240, diagnosed between ages 15-39 \[current age 18-39\], posttreatment \>6 months, body mass index \[BMI\] 25-50 kg/m2) will be randomized to: 1) mHealth intervention or 2) self-guided (digital tools + education + peer support only). Randomization will be stratified by BMI, sex assigned at birth, and race/ethnicity. Assessments will occur at 0 (baseline), 3 (intervention mid-point), 6 (post-intervention), and 12 months (follow-up). Percent weight change at 6 months (primary outcome) will be assessed using a remote data collection protocol via fasted video weigh-in via smart scale to facilitate enhanced reach across the US. Secondary outcomes include frailty (frailty index), objectively measured physical activity (Fitbit), dietary intake (ASA24), and quality of life (SF-36), as well as validated surveys assessing hypothesized psychosocial mediators targeted by the intervention. A subsample of participants will complete in-person visits at each clinical site (UNC and VCU) at 0, 6, and 12 months to assess changes in body composition, waist circumference, frailty, and biomarkers of aging and cardiometabolic disease. Specific aims are:

AIM 1: To test the efficacy of a theory-based, mHealth weight management intervention compared with a self-guided control arm on percent weight change among AYA cancer survivors.

AIM 2: To determine the efficacy of the intervention compared to self-guided control on secondary outcomes.

AIM 3: To examine whether changes in putative theoretical mechanisms (competence, relatedness, autonomy) mediate the effects of the intervention on weight change.

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
* 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

Primary outcomes:
measure: Weight change percent
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Weight maintenance percent
timeFrame: 6 to 12 months
measure: Body Mass Index (BMI)
timeFrame: Baseline up to 12 months
measure: Health-related quality of life
timeFrame: Baseline up to 12 months
measure: Diet quality
timeFrame: Baseline up to 12 months
measure: Device-measured physical activity
timeFrame: Baseline up to 12 months
measure: Self-reported physical activity
timeFrame: Baseline up to 12 months
measure: Frailty Index
timeFrame: Baseline up to 12 months
measure: Frailty Phenotype
timeFrame: Baseline up to 12 months
measure: p16 Expression
timeFrame: Baseline up to 12 months
measure: Biomarkers of cardiovascular disease
timeFrame: Baseline up to 12 months
measure: Blood pressure
timeFrame: Baseline up to 12 months
measure: Waist circumference
timeFrame: Baseline up to 12 months
measure: Body composition assessed by Air Displacement Plesthymography
timeFrame: Baseline up to 12 months
measure: Accelerometer measured physical activity
timeFrame: Baseline up to 12 months
Other outcomes:
measure: Depressive Symptoms
timeFrame: Baseline up to 12 months
measure: Perceived Stress
timeFrame: Baseline up to 12 months
measure: Anxiety
timeFrame: Baseline up to 12 months
measure: Global Health
timeFrame: Baseline up to 12 months
measure: Competence
timeFrame: Baseline up to 12 months
measure: Relatedness
timeFrame: up to 12 months
measure: Autonomy Support
timeFrame: up to 12 months
measure: Autonomous Motivation
timeFrame: Baseline up to 12 months
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carmina G. Valle, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Jessica Gokee LaRose, PhD
role: PRINCIPAL_INVESTIGATOR
References: