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CancerAYAConnectNCT06171945

Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors

A study testing AYA Connect intervention, Positive Psychology (PP) intervention and Positive Psychology Plus (PP+) intervention in people with Cancer and Physical Activity, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to conduct a 6-month pilot randomized trial to determine the feasibility and acceptability of theory-based mobile weight loss interventions for survivors of adolescent and young adult cancer (AYAs). Read more about this study

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Cancer, Physical Activity, Cancer Survivorship
What is being tested?
AYA Connect intervention, Positive Psychology (PP) intervention and Positive Psychology Plus (PP+) intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteUnited States
Study dates
1 Mar 2024to 5 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

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

  • Currently age 18-39
  • Diagnosed with first invasive cancer between the ages of 15-39 years old
  • Within 10 years of diagnosis with no evidence of progressive disease or second primary cancers
  • Completed active cancer-directed therapy (cytotoxic chemotherapy, radiation therapy, and/or definitive surgical intervention) at least six months prior to enrollment, except maybe receiving "maintenance" therapy to prevent recurrences
  • Body Mass Index (BMI) of 25-50 kg/m2

Who cannot join

  • Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes
  • Report a history of heart attack or stroke within the previous 6 months
  • Health problems that preclude the ability to walk for physical activity
  • Lost 5% or more of body weight (and kept it off) in the last 3 months
  • Past diagnosis of or receiving treatment for a clinically diagnosed eating disorder (anorexia nervosa or bulimia nervosa) or any compensatory behaviors within the previous 3 months
  • Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
Show all 16Show fewer
  • Untreated thyroid disease or any changes (type or dose) in thyroid medication in the last 6 months
  • Hospitalization for depression or other psychiatric disorder within the past 12 months
  • History of psychotic disorder or 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.
  • Previous surgical procedure for weight loss or planned weight loss surgery in the next 6 months
  • Inability to speak and read English
  • Do not have an iPhone with active data and text messaging plan
  • No Internet access
  • Not willing to be randomized to either intervention arm

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: A Pilot Randomized Trial of a Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors

The purpose of this study is to conduct a 6-month pilot randomized trial to determine the feasibility and acceptability of theory-based mobile weight loss interventions for survivors of adolescent and young adult cancer (AYAs). The interventions use a mobile smartphone application, previously developed for individuals at risk for type 2 diabetes and adapted for AYAs, that integrates weight and physical activity from digital devices with simplified dietary monitoring in a behavioral weight loss program.

Read the detailed description

The purpose of this study is to conduct a 6-month pilot randomized trial to determine the feasibility and acceptability of three adapted theory-based, mobile weight loss interventions delivered via a native smartphone application among AYAs: 1) AYA Connect; 2) AYA Connect enhanced with positive psychology strategies (AYA Connect-PP); and 3) AYA Connect enhanced with positive psychology strategies plus coaching (AYA Connect-PP+).

The 3-month interventions are aimed at promoting improvements in diet quality consistent with recommendations for cancer survivors, a decrease in energy intake, an increase in energy expenditure, modest weight loss, and an increase in positive affect. The 3-month interventions will be followed by a 3-month maintenance phase (no contact). Assessments will occur at baseline, 3 (post-intervention), and 6 months (maintenance). Weight will be collected via smart scales mailed to participants. Adherence measures will include daily self-monitoring of weight (smart scale), physical activity (activity tracker), and dietary intake (food log in AYA Connect app).

Young adults (n=60), ages 18-39, diagnosed with invasive malignancy between the ages of 15-39 years, post-cancer treatment, with body mass index (BMI) of 25-50 kg/m2 will be recruited from around the United States to participate in the pilot randomized trial. Participants will be randomized into one of three conditions: 1) AYA Connect intervention; 2) AYA Connect-PP intervention; and 3) AYA Connect-PP+ intervention.

Group 1: AYA Connect Intervention: These participants will receive a smart scale, activity tracker, an individual kickoff video chat session with a health coach, and access to a mobile smartphone app that includes weekly behavioral lessons, dietary tracking log, daily weight-related behavioral goals, tailored feedback summaries, and in-app health-related messages.

Group 2: AYA Connect-PP Intervention: In addition to the intervention components Group 1 will receive, these participants will also receive lessons about positive psychology (PP) strategies, weekly goals for PP exercises, and in-app health-related messages that include reminders to practice PP exercises.

Group 3: AYA Connect-PP+ Intervention: In addition to the intervention components Group 2 will receive, these participants also will receive weekly individual video chat sessions with a health coach.

Being tested
AYA Connect intervention, Positive Psychology (PP) intervention, Positive Psychology Plus (PP+) intervention
Keywords
adolescent, young adult, mobile application, physical activity, nutrition, overweight, positive psychology, digital intervention, diet, weight loss, weight management, bladder cancer, bone cancer, brain cancer, breast cancer, cervical cancer, colon cancer, endometrial cancer, head and neck cancer, leukemia
Medical subject headings
Neoplasms, Motor Activity, Psychological Well-Being, Obesity, Overweight, Weight Loss, Urinary Bladder Neoplasms, Bone Neoplasms

What participants receive

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

  • AYA Connect interventionBehavioural

    Participants will receive a smart scale, activity tracker, an individual kickoff videochat session with a health coach, and access to a mobile smartphone app that includes weekly behavioral lessons, dietary tracking log, daily weight-related behavioral goals, tailored feedback summaries, and in-app health-related messages.

  • Positive Psychology (PP) interventionBehavioural

    Participants will receive lessons about positive psychology (PP) strategies, weekly goals for PP exercises, and in-app health-related messages that include reminders to practice PP exercises.

  • Positive Psychology Plus (PP+) interventionBehavioural

    Participants will receive weekly individual videochat sessions with a health coach.

Study groups in NCT06171945
Study groupRoleWhat they receive
AYA ConnectExperimentalAdolescent and young adult cancer survivors receive AYA Connect intervention.
Receives: Behavioral: AYA Connect intervention
AYA Connect-PPExperimentalAdolescent and young adult cancer survivors receive AYA Connect-PP intervention.
Receives: Behavioral: AYA Connect intervention; Behavioral: Positive Psychology (PP) intervention
AYA Connect-PP+ExperimentalAdolescent and young adult cancer survivors receive AYA Connect-PP+ intervention.
Receives: Behavioral: AYA Connect intervention; Behavioral: Positive Psychology (PP) intervention; Behavioral: Positive Psychology Plus (PP+) intervention

What is being measured

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

  1. Feasibility of interventions as measured by accrual rate

    Feasibility of interventions as measured by accrual rate will be calculated as the number of adolescent and young adult cancer (AYA) survivors who agreed to participate divided by the number of months of recruitment

    Measured: at 3 months

  2. Feasibility of interventions as measured by participation rate

    Feasibility of interventions as measured by participation rate will be calculated as the number of participants who agreed to participate divided by the number of eligible AYA survivors.

    Measured: at 3 months

  3. Feasibility of interventions as measured by retention rate

    Feasibility of interventions as measured by retention rate will be calculated as the number of AYA survivor participants who completed 3-month measures divided by the number who participated.

    Measured: At 3 months

Secondary outcomes (20)
  1. Retention rate at 6 months

    Retention rate at 6 months, calculated by the number of participants who completed all study measures at the 6-month time point divided by the number who participated.

    Measured: At 6 months

  2. Acceptability of Young Adult Cancers (AYAs) Connect

    Acceptability of the interventions will be measured by ratings of program acceptability and satisfaction. Participants will provide ratings on the helpfulness and difficulty of the program's behavioral goals (e.g., diet and physical activity goals) using an 8-point scale (1 = Not satisfied/Very difficult to 8 = Very satisfied/very easy). Additional questions will ask participants about the helpfulness of intervention features (e.g., lessons, feedback messages) for reaching their weight goals (1 = Not at all helpful to 4 = Extremely helpful). Higher scores indicate greater acceptability.

    Measured: At 3 and 6 month

  3. Adherence to dietary tracking

    Number of days red foods (high-calorie, high-fat foods) are tracked, as measured by the food log data in the AYA Connect app. Participants will be asked to log their red foods in the app daily.

    Measured: Up to 6 month

  4. Adherence to physical activity monitoring

    Number of days physical activity is tracked, as measured by activity tracker

    Measured: Up to 6 month

  5. Adherence to self-weighing

    Number of days weighed, as measured by smart scale

    Measured: Up to 6 month

  6. Change in weight

    Change in weight, as measured by smart scale, from baseline to 3 and 6 months.

    Measured: Up to 6 month

  7. Change in energy intake

    Change in energy intake (kcal), measured using the NCI Automated Self-Administered 24-hour Recall (ASA-24). The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate energy intake.

    Measured: from the baseline to 3 and 6 month

  8. Change in saturated fat intake

    Change in saturated fat intake (% kcal), measured using the NCI Automated Self-Administered 24-hour Recall (ASA-24 The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate saturated fat intake.

    Measured: from the baseline to 3 and 6 month

  9. Change in fruit and vegetable consumption

    Change in fruit and vegetable consumption (cups), measured using the NCI Automated Self-Administered 24-hour Recall (ASA-24). The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate average fruit and vegetable consumption.

    Measured: from the baseline to 3 and 6 month

  10. Change in fiber consumption

    Change in fiber consumption (g), measured using the NCI Automated Self-Administered 24-hour Recall (ASA-24). The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate fiber consumption.

    Measured: from the baseline to 3 and 6 month

  11. Change in Healthy Eating Index score

    Change in Healthy Eating Index (HEI) score, measured using the HEI and the NCI Automated Self-Administered 24-hour Recall (ASA-24). The ASA-24 will be administered on one weekend day and one week day per assessment period to estimate HEI. HEI scores range from 0 to 100, with higher scores indicating greater adherence to the Dietary Guidelines for Americans.

    Measured: from the baseline to 3 and 6 month

  12. Change in weekly minutes of moderate-to-vigorous activity

    Changes in weekly minutes of moderate-to-vigorous activity, computed from the participant's activity tracker data and averaged over a minimum of 4 out of a 7-day period. Participants will be instructed to wear the activity tracker at all times.

    Measured: From baseline to 3 and 6 months

  13. Change in steps per day

    Changes in daily steps, were computed from the participant's activity tracker data and averaged over a minimum of 4 out of a 7-day period. Participants will be instructed to wear the activity tracker at all times.

    Measured: From baseline to 3 and 6 months

  14. Change in self-reported physical activity

    Change in self-reported physical activity, measured using the Paffenbarger Activity Scale (PAQ). 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.

    Measured: From baseline to 3 and 6 months

  15. Change in frailty index

    Change in frailty index, measured using the FRAIL Questionnaire. The FRAIL Questionnaire assesses: 1) self-reported fatigue (1 item from Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health), 2) weight loss, 3) comorbidities (11 items from UNC Health Registry Comorbidity Assessment), 4) difficulty with ambulation (1 item from PROMIS Global Health), and 5) ability to overcome resistance (1 item from Medical Outcomes Study 36-Item Short Form). Positive responses for these components are summed to create the FRAIL index (range 0-5). A value > 3 is considered frail, and a value of 2 is considered prefrail.

    Measured: From baseline to 3 and 6 months

  16. Change in health-related quality of life

    Change in health-related quality of life, 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.

    Measured: From baseline to 3 and 6 months

  17. Change in depressive symptoms

    Change in depressive symptoms, measured by the Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a self-report depression scale including 20 items that relate to depressive feelings and behaviors during the past week. Response options range from 0 (rarely or none of the time) to 3 (most or almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

    Measured: From baseline to 3 and 6 months

  18. Change in anxiety symptoms

    Change in anxiety symptoms, as measured using the Generalized Anxiety Disorder 7-item scale (GAD-7). Possible scores range from 0 to 21, with higher scores reflecting greater symptom severity; cut-points of 5, 10, and 15 correspond to mild, moderate, and severe levels of anxiety.

    Measured: From baseline to 3 and 6 months

  19. Change in perceived stress

    Change in perceived stress, measured by the 10-item Perceived Stress Scale (PSS-10). PSS-10 measures overall perceived stress during the past month. Factor analysis supports a two-factor correlated model with perceived self-efficacy and perceived helplessness subscales.

    Measured: From baseline to 3 and 6 months

  20. Change in positive and negative affect

    Change in positive and negative affect, measured using the Positive and Negative Affect Schedule (PANAS). PANAS is a 20-item scale divided into two subscales to measure positive and negative affect. Each item is rated on a five-point Likert scale from 1 (very slightly or not at all) to 5 (extremely) and are summed to yield scores for each subscale.

    Measured: From baseline to 3 and 6 months

Timeline

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

  1. First posted15 Dec 2023
  2. Study start1 Mar 2024
  3. Primary completion13 Jul 2025
  4. Study completion5 Oct 2025

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06171945
Sponsor's protocol ID
LCCC2133
Acronym
AYAConnect
Status last verified
Oct 2025
First submitted
27 Nov 2023
Last updated
27 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AYA Connect intervention, Positive Psychology (PP) intervention and Positive Psychology Plus (PP+) intervention in people with Cancer and Physical Activity, 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 16 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: finished, as of the sponsor's last update on 27 Oct 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of interventions as measured by accrual rate (time frame: at 3 months). The study lists 3 primary outcomes in all. 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 27 Oct 2025.

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