NCT06191666

BfedBwell Proof-of-Concept Pilot

Design and Integration of a Survivorship Nutrition Intervention Into an Established Exercise Oncology Program: the BfedBwell Pilot Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This single-arm proof-of-concept pilot will assess the feasibility and acceptability of integrating a survivorship nutrition intervention (BfedBwell) into an existing clinical exercise oncology program (BfitBwell).

Detailed description

Individuals with experience in delivery of lifestyle (e.g., diet, physical activity) interventions will be recruited to deliver and evaluate the integrated BfedBwell + BfitBwell intervention. Cancer survivors with overweight/obesity who have completed active treatment will be recruited from the University of Colorado Anschutz Medical Campus for participation in a 12-week single-arm study of the integrated BfedBwell + BfitBwell intervention. Feasibility and acceptability will be evaluated. Exploration of intervention effect on adherence to cancer survivorship guidelines, body composition, and cardiometabolic indicators of health will be used to evaluate proof-of-concept prior to advancing to efficacy testing.

Conditions

• Cancer Survivorship
• Obesity
• Overweight

Interventions

Type	Name	Description
BEHAVIORAL	Group-based education and discussion	Group-based education and discussion (60 minutes each per week, virtual and in-person) based upon guidelines for nutrition for cancer survivorship (e.g., follow a plant-based diet with a variety of vegetables, fruits, whole grains, and legumes; limit alcohol intake; reduce consumption of highly processed foods and foods high in salt; achieve a weekly calorie deficit of approximately 3500 kcal for weight loss)
BEHAVIORAL	Individual 1:1 counseling	Individual 1:1 counseling sessions (30 minutes each per month, virtual) with an RD to review progress and address barriers
BEHAVIORAL	Group based behavioral skills development and cooking demonstrations	Group-based behavioral skills development sessions and cooking demonstrations (60-90 minutes each per month, in-person) to focus on behavior change techniques (e.g., self-monitoring, goal setting) and nutrition skills (e.g., recipe development, label reading).
BEHAVIORAL	BfitBwell	This program consists of a supervised exercise program developed by a cancer exercise specialist and based upon the NCCN guidelines for physical activity during cancer survivorship and other recommendations.

Timeline

• Start date: 2024-02-05
• Primary completion: 2024-12-16
• Completion: 2024-12-16
• First posted: 2024-01-05
• Last updated: 2026-02-11

Locations

1 site across 1 country: United States