NCT05887401

Physical Activity and Healthy Eating Among Young Adult Cancer Survivors

A Pilot Randomized Factorial Trial to Promote Physical Activity and Healthy Eating Among Young Adult Cancer Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot randomized factorial trial is to test the feasibility, acceptability, and effects of a theory-based mobile physical activity and nutrition intervention designed specifically for young adult cancer survivors to increase physical activity and diet quality.

Detailed description

There are around 1 million young adult cancer survivors in the United States. Young adult cancer survivors are an underserved and vulnerable subgroup of survivors that experience increased risk for chronic health conditions like cardiovascular disease, metabolic syndrome, secondary cancers, premature aging, and premature death. Modifiable lifestyle factors contribute to and compound risks for late and long-term health effects from cancer and its treatment, making them high-impact targets for behavioral interventions. International consensus guidelines recommend cancer survivors of all ages be physically active, consume a healthy diet, and achieve and maintain a healthy weight. Fewer than half of young adult cancer survivors meet guideline recommendations for vegetable intake, physical activity and the majority self-report having an overweight/obese BMI. To date, there are few physical activity interventions, and no nutritional interventions designed specifically for young adult cancer survivors. Digital behavior change interventions have emerged as feasible and efficacious approaches to reach and address unmet needs among young adult cancer survivors as they overcome barriers of time, flexibility, affordability, and access. Reaching these populations has been facilitated by digital tools like wearable devices that enable real-time data capture to guide the provision of individualized feedback and tailored goal setting based on personal progress. This pilot trial will use the Multiphase Optimization Strategy (MOST), an engineering-inspired framework, and a highly efficient experimental design to evaluate the feasibility of 4 intervention components to improve physical activity and nutrition behaviors among young adult cancer survivors. Young adult cancer survivors (n=80), diagnosed between ages 18-39, will be recruited to receive a core 3-month digital physical activity and nutrition intervention that includes evidence-based lessons and behavioral skills training with an emphasis on adherence to American Cancer Society (ACS) guidelines for cancer survivors and self-monitoring of physical activity and dietary behaviors. Additionally, participants will be randomized to four intervention components--each with two levels-- including: 1) simplified dietary tracking (daily tracking of green (low-calorie, high nutrients) vs. red (high-calorie, high-fat, low nutrients) foods), 2) dietary goals using simplified approach (daily goals vs. no goals), 3) supportive text messages (yes vs. no), 4) lesson delivery (all provided once vs. weekly). Assessments of outcomes will be conducted at baseline, 6 weeks, and 3 months to accomplish the following specific aims: 1) Evaluate the feasibility and acceptability the intervention at 3 months; 2) Evaluate intervention effects on change in physical activity and diet quality; 3) Evaluate intervention effects on secondary outcomes at 6 weeks and 3 months; and 4) Explore whether theoretical constructs (perceived competence, self-regulation, self-efficacy, and perceived relatedness) mediated the effects of the intervention on change in health behaviors at 3 months.

Conditions

• Physical Activity
• Neoplasms
• Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Core Intervention	The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
BEHAVIORAL	Simplified Dietary Monitoring (Green)	Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
BEHAVIORAL	Simplified Dietary Monitoring (Red)	Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
BEHAVIORAL	Nutrition Goals (Yes)	Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.
BEHAVIORAL	Nutrition Goals (No)	Participant will not be assigned a personalized weekly nutrition goal.
BEHAVIORAL	Supportive Text Messages (Yes)	Participant will receive up to 5 supportive text-messages from the study staff per week.
BEHAVIORAL	Supportive Text Messages (No)	Participant will not receive supportive text-messages.
BEHAVIORAL	Lesson Delivery (Once)	All behavioral lessons will be made available to participant simultaneously.
BEHAVIORAL	Lesson Delivery (Weekly)	A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.

Timeline

• Start date: 2023-10-02
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2023-06-02
• Last updated: 2025-12-24
• Results posted: 2025-12-24

Locations

1 site across 1 country: United States