NCT06184256

BfedBwell Optimization Pilot

BfedBwell: Multiphase Optimization Strategy Pilot Trial of a Nutrition Intervention for Cancer Survivors With Overweight and Obesity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Using the Multiphase Optimization Strategy (MOST) framework, an engineering-based approach to efficiently and systematically develop, optimize, and evaluate behavioral interventions, this study will test three components: (1) 1:1 counseling with a registered dietitian, (2) behavioral skills development, and (3) group support for delivery alongside a core nutrition curriculum within a clinical exercise oncology program.

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 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 6-month cluster-randomized 2\^3-factorial pilot optimization trial of the BfedBwell 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 determine a set of components that demonstrate patterns of efficacy.

Conditions

• Survivorship
• Cancer

Interventions

Type	Name	Description
BEHAVIORAL	BfedBwell - Core Curriculum	12-week core nutrition education curriculum + 12-week tapered maintenance curriculum
BEHAVIORAL	BfedBwell - 1:1 Counseling	Individual 1:1 counseling sessions with a registered dietitian
BEHAVIORAL	BfedBwell - Behavioral Skills	Group-based behavioral skills development sessions
BEHAVIORAL	BfedBwell - Group Support	Structured group support sessions
BEHAVIORAL	Program delivery	Delivery and evaluation of one or more intervention components

Timeline

• Start date: 2025-02-05
• Primary completion: 2026-07-01
• Completion: 2028-02-01
• First posted: 2023-12-28
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States