Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors

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Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 39 Years
Gender	All

More Inclusion & Exclusion Criteria

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06171945
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	UNC Lineberger Comprehensive Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Carmina Valle, PhD
Principal Investigator Affiliation	UNC Lineberger Comprehensive Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cancer, Physical Activity, Cancer Survivorship, Mental Health, Obesity
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: AYA Connect

Adolescent and young adult cancer survivors receive AYA Connect intervention.

Experimental: AYA Connect-PP

Adolescent and young adult cancer survivors receive AYA Connect-PP intervention.

Experimental: AYA Connect-PP+

Adolescent and young adult cancer survivors receive AYA Connect-PP+ intervention.

Interventions

Behavioral: - AYA Connect intervention

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.

Behavioral: - Positive Psychology (PP) intervention

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.

Behavioral: - Positive Psychology Plus (PP+) intervention

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Chapel Hill, North Carolina

Status

Address

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599