Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors

Phase

N/A

Condition

Obesity

Neoplasms

Rectal Cancer

Treatment

Positive Psychology (PP) intervention

Positive Psychology Plus (PP+) intervention

AYA Connect intervention

Clinical Study ID

NCT06171945

LCCC2133

Ages 18-39
All Genders

Study 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). 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.

Eligibility Criteria

Inclusion

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 secondprimary 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

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 theprevious 3 months
Currently pregnant, pregnant within the past 6 months, or planning to becomepregnant within the next 6 months
Untreated thyroid disease or any changes (type or dose) in thyroid medication in thelast 6 months
Hospitalization for depression or other psychiatric disorder within the past 12months
History of psychotic disorder or bipolar disorder
Currently participating in a weight loss, nutrition, or physical activity study orprogram 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 thenext 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

Study Design

Positive Psychology (PP) intervention

March 01, 2024

October 05, 2025

Study 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.

Connect with a study center

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina 27599
United States
Site Not Available
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27599
United States
Site Not Available

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