Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors

N/ACompletedNCT06171945

UNC Lineberger Comprehensive Cancer Center63 enrolled

Overview

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.

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.

Interventions

AYA Connect interventionBEHAVIORAL

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) interventionBEHAVIORAL

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+) interventionBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 39 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: at 3 months

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.

Time frame: at 3 months

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.

Time frame: At 3 months

Secondary Outcomes

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.

Time frame: At 6 months

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.

Time frame: At 3 and 6 month

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.

Time frame: Up to 6 month

Adherence to physical activity monitoring

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

Time frame: Up to 6 month

Adherence to self-weighing

Number of days weighed, as measured by smart scale

Time frame: Up to 6 month

Change in weight

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

Time frame: Up to 6 month

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.

Time frame: from the baseline to 3 and 6 month

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.

Time frame: from the baseline to 3 and 6 month

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.

Time frame: from the baseline to 3 and 6 month

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.

Time frame: from the baseline to 3 and 6 month

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.

Time frame: from the baseline to 3 and 6 month

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.