Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors
NCT ID: NCT06171945
Last Updated: 2025-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2024-03-01
2025-10-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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AYA Connect
Adolescent and young adult cancer survivors receive AYA Connect intervention.
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.
AYA Connect-PP
Adolescent and young adult cancer survivors receive AYA Connect-PP intervention.
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.
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.
AYA Connect-PP+
Adolescent and young adult cancer survivors receive AYA Connect-PP+ intervention.
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.
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.
Positive Psychology Plus (PP+) intervention
Participants will receive weekly individual videochat sessions with a health coach.
Interventions
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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.
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.
Positive Psychology Plus (PP+) intervention
Participants will receive weekly individual videochat sessions with a health coach.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
39 Years
ALL
No
Sponsors
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UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Carmina Valle, PhD
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
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Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Related Links
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Clinical trials at UNC Lineberger
Other Identifiers
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LCCC2133
Identifier Type: -
Identifier Source: org_study_id
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