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

Not Applicable

Not yet recruiting

• Conditions: Obesity; Cancer; Cancer Survivorship; Physical Activity; Diet

• Registration Number: NCT06848491
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-02-21
• Study First Posted: 2025-02-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-22
• Study Start: 2025-06-01
• Primary Completion: 2027-10-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight change percent	Baseline to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Weight maintenance percent	6 to 12 months	Weight will be objectively measured on a digital scale in the participant's home for remote participants and in the clinic for clinic subsample. Percent weight change at 6 months is calculated as ((weight (kg) at 6 months - weight (kg) at baseline)/(weight (kg) at baseline))\*100. Maintenance of weight change is measured from 6 to 12 months.
Body Mass Index (BMI)	Baseline up to 12 months	Change in body mass index is calculated as weight in kg divided by the square of height in meters. BMI is calculated at each weight assessment and change over time is assessed.
Health-related quality of life	Baseline up to 12 months	Change in health-related quality of life is measured using the Medical Outcomes Study 36-Item Short Form (SF-36) survey. This survey includes 36 items with eight subscales (physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions). Responses are coded on a scale of 0 to 100, where 0 is the worst possible health and 100 is the most favorable health score. The coded responses will be summed to yield a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. The measure is administered at baseline, 3, 6, and 12 months and change over time is assessed.
Diet quality	Baseline up to 12 months	Diet Quality id assessed using the Healthy Eating Index (HEI) using data from the National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA-24). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome. Participants complete a weekday and weekend day recall at baseline, 6, and 12 months and change over time is assessed.
Device-measured physical activity	Baseline up to 12 months	Change in physical activity is measured as a sum of weekly minutes of light and moderate-to-vigorous physical activity at 6 and 12 months compared to baseline, assessed via wrist-worm Fitbit device. Participants are asked to wear the Fitbit device for a one week during each assessment period at baseline, 6, and 12 months. Change in weekly active minutes will be assessed over time.
Self-reported physical activity	Baseline up to 12 months	Physical activity will be assessed using the Paffenbarger Physical Activity Questionnaire (PAQ) which assesses leisure-time activity. The PAQ provides an estimate of minutes per week of moderate-to-vigorous intensity, and calories/week of light (5 kcal/min), medium (7.5 kcal/min), and high (10 kcal/min) intensity activities. PAQ changes have been predictive of weight change. The measure is administered at baseline, 6, and 12 months and change over time is assessed.
Frailty Index	Baseline up to 12 months	Frailty will be assessed among all participants with a Frailty Index (all participants) Five items assess self-reported fatigue (from SF-36), weight loss, morbidities, difficulty with ambulation (PROMIS Global Health), and ability to overcome resistance (from SF-36).181 The number of positive responses for these components is summed to create the FRAIL index (range 0-5). A value \> 3 is considered frail, and a value of 2 is considered prefrail. Frailty is measured at baseline, 6, and 12 months and change over time is assessed.
Biomarkers of cardiovascular disease	Baseline up to 12 months	Fasting blood samples (after an overnight fast of at least 8 hours) will be collected from a subset of participants assessed in person. At each assessment, a whole blood sample (collected in one 8.5 mL SST tube) will be collected, processed to serum, and analyzed by LabCorp for lipids (total cholesterol, HDL-C, LDL-C and triglycerides), glucose, and insulin levels. The measures are collected at baseline, 6, and 12 months and change over time will be assessed.
Frailty Phenotype	Baseline up to 12 months	Frailty will be assessed in a subset of participants assessed in person with a modified Fried frailty phenotype. The modified Fried frailty phenotype includes five clinically derived factors: 1) weakness (sitting dominant hand-grip strength using hand-held dynamometer and BMI-specific cut points); 2) slowness (timed 15-foot walk); 3) sarcopenia (relative mass of =1.5 SDs below age-, sex-, race-specific values from NHANES using bioelectrical impedance analysis; 4) exhaustion (vitality subscale of SF-36; and 5) low energy expenditure (\<383 kcal/week for males, \< 270 kcal/week for females from Paffenbarger Physical Activity Questionnaire). Individuals with 3 factors are classified as frail and those with 2 factors as pre-frail. Frailty is measured at baseline, 6, and 12 months and change over time is assessed.
p16 Expression	Baseline up to 12 months	Peripheral blood will be collected from a subset of participants assessed in-person. Samples will be used to measure expression of T lymphocyte p16. At each assessment, a whole blood sample of 8mL will be drawn and collected into a 8mL ACD tube. From the ACD tube, analysis of p16 expression will be measured using a TaqMan quantitative reverse-transcription polymerase chain reaction (RTPCR) performed by Sapere Bio (Research Triangle Park, NC). The measure is collected at baseline, 6, and 12 months and change over time will be assessed.
Blood pressure	Baseline up to 12 months	Blood pressure will be assessed in a subset of participants assessed in person with a calibrated blood pressure monitor. Cuff size will be determined by arm circumference. After a 5-minute rest period and with both feet flat on floor, three readings will be taken, with 60 seconds between measurements. The measurement is collected at baseline, 6, and 12 months and change in systolic and diastolic blood pressure will be assessed over time.
Waist circumference	Baseline up to 12 months	Waist circumference will be assessed in a subset of participants assessed in person, measured at the midpoint between highest point of iliac crest and lowest point of costal margin using a Gulik tape measure and following a standard protocol. Two measures of waist circumference are taken; if the difference exceeds 0.5 cm, a third measure is taken. The measurement is collected at baseline, 6, and 12 months and change over time will be assessed.
Body composition assessed by Air Displacement Plesthymography	Baseline up to 12 months	Body composition assessed in a subset of participants with the BodPod (COSMED USA, Inc.). Participants are asked to fast for 8 hours (including caffeine) and to refrain from strenuous exercise for 8 hours prior to these body composition measures. Outcome variable of interest is change in the ratio of lean muscle mass to fat mass. The measurement is collected at baseline, 6, and 12 months and change in the ratio of lean muscle mass to fat mass is assessed over time.
Accelerometer measured physical activity	Baseline up to 12 months	Physical activity will be assessed among the subset of participants completing in-person assessments using ActiGraph accelerometers (GT3X+, Pensacola, FL), which provides an objective assessment to corroborate self-report PA and sedentary activity data. Participants will be instructed to wear the device at all times for a full week; monitoring for at least 600 min/day for at least 5 days in the week (including at least one weekday and one weekend day) is considered adequate for analysis. Data will be aggregated into sedentary, light and MVPA using standard thresholds. Physical activity with accelerometer will be assessed at baseline, 6, and 12 months.