Clinical trial NCT06171945: Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors
Official title: A Pilot Randomized Trial of a Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Physical Activity
Cancer Survivorship
Mental Health
Obesity
Keywords: adolescent
young adult
mobile application
physical activity
nutrition
overweight
positive psychology
digital intervention
diet
weight loss
weight management
bladder cancer
bone cancer
brain cancer
breast cancer
cervical cancer
colon cancer
endometrial cancer
head and neck cancer
leukemia
liver cancer
lymphoma (Hodgkin's)
lymphoma (Non-Hodgkin's)
melanoma
oral cancer
pancreatic cancer
pharyngeal cancer
rectal cancer
renal cancer
sarcoma
testicular cancer
thyroid cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Feasibility of interventions as measured by accrual rate
timeFrame: at 3 months
measure: Feasibility of interventions as measured by participation rate
timeFrame: at 3 months
measure: Feasibility of interventions as measured by retention rate
timeFrame: At 3 months
Secondary outcomes:
measure: Retention rate at 6 months
timeFrame: At 6 months
measure: Acceptability of Young Adult Cancers (AYAs) Connect
timeFrame: At 3 and 6 month
measure: Adherence to dietary tracking
timeFrame: Up to 6 month
measure: Adherence to physical activity monitoring
timeFrame: Up to 6 month
measure: Adherence to self-weighing
timeFrame: Up to 6 month
measure: Change in weight
timeFrame: Up to 6 month
measure: Change in energy intake
timeFrame: from the baseline to 3 and 6 month
measure: Change in saturated fat intake
timeFrame: from the baseline to 3 and 6 month
measure: Change in fruit and vegetable consumption
timeFrame: from the baseline to 3 and 6 month
measure: Change in fiber consumption
timeFrame: from the baseline to 3 and 6 month
measure: Change in Healthy Eating Index score
timeFrame: from the baseline to 3 and 6 month
measure: Change in weekly minutes of moderate-to-vigorous activity
timeFrame: From baseline to 3 and 6 months
measure: Change in steps per day
timeFrame: From baseline to 3 and 6 months
measure: Change in self-reported physical activity
timeFrame: From baseline to 3 and 6 months
measure: Change in frailty index
timeFrame: From baseline to 3 and 6 months
measure: Change in health-related quality of life
timeFrame: From baseline to 3 and 6 months
measure: Change in depressive symptoms
timeFrame: From baseline to 3 and 6 months
measure: Change in anxiety symptoms
timeFrame: From baseline to 3 and 6 months
measure: Change in perceived stress
timeFrame: From baseline to 3 and 6 months
measure: Change in positive and negative affect
timeFrame: From baseline to 3 and 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Carmina Valle, PhD
role: PRINCIPAL_INVESTIGATOR
References: