Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors (AYAConnect)
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About
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.
Full 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.
Enrollment
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Inclusion and 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 design
Primary purpose
Allocation
Interventional model
Masking
77 participants in 3 patient groups
Trial contacts and locations
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Central trial contact
Molly Diamond, MPH
Data sourced from clinicaltrials.gov
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