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ObesityAYAWellNCT06848491

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

A study testing AYA WELL Intervention and Self-Guided in people with Obesity and Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Obesity, Cancer, Physical Activity
What is being tested?
AYA WELL Intervention and Self-Guided
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteUnited States
Study dates
27 Oct 2025to 31 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Molly Diamond, MPH contact

919-966-5852

mdiamond@unc.edu

Karen E. Hatley, MPH, RD contact

919-966-5853

keericks@email.unc.edu

United States1 site, 1 recruiting
  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

    Karen Hatley E Research Project Manager, MPH, RD, LDN, 919-966-5853, keericks@email.unc.edu

    Molly Diamond Research Associate, MPH, mdiamond@unc.edu

    Recruiting

Other trials in United States

About this study

Official title: Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors (AYA Well)

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.

Read the 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.

Being tested
AYA WELL Intervention, Self-Guided
Medical subject headings
Obesity, Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AYA WELL InterventionBehavioural

    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-GuidedBehavioural

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

Study groups in NCT06848491
Study groupRoleWhat they receive
InterventionExperimentalIntervention 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.
Receives: Behavioral: AYA WELL Intervention
Self-GuidedActive 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.
Receives: Behavioral: Self-Guided

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 6 months

Secondary outcomes (14)
  1. Weight maintenance percent

    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.

    Measured: 6 to 12 months

  2. Body Mass Index (BMI)

    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.

    Measured: Baseline up to 12 months

  3. Health-related quality of life

    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.

    Measured: Baseline up to 12 months

  4. Diet quality

    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.

    Measured: Baseline up to 12 months

  5. Device-measured physical activity

    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.

    Measured: Baseline up to 12 months

  6. Self-reported physical activity

    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.

    Measured: Baseline up to 12 months

  7. Frailty Index

    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.

    Measured: Baseline up to 12 months

  8. Frailty Phenotype

    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.

    Measured: Baseline up to 12 months

  9. p16 Expression

    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.

    Measured: Baseline up to 12 months

  10. Biomarkers of cardiovascular disease

    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.

    Measured: Baseline up to 12 months

  11. Blood pressure

    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.

    Measured: Baseline up to 12 months

  12. Waist circumference

    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.

    Measured: Baseline up to 12 months

  13. Body composition assessed by Air Displacement Plesthymography

    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.

    Measured: Baseline up to 12 months

  14. Accelerometer measured physical activity

    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.

    Measured: Baseline up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2025
  2. Study start27 Oct 2025
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06848491
Sponsor's protocol ID
LCCC2318
Other IDs
5R01CA270111
Acronym
AYAWell
Status last verified
Aug 2026
First submitted
21 Feb 2025
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing AYA WELL Intervention and Self-Guided in people with Obesity and Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Molly Diamond, MPH (919-966-5852, mdiamond@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight change percent (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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