NCT07446595

BfedBwell INSPIRE Pilot

BfedBwell INSPIRE: Impact of an Integrated Nutrition and Exercise Program for Post-treatment Survivors on Sleep Quality, Perceived Stress, and Biomarkers of Immune Dysregulation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This single-arm pilot study will evaluate the feasibility and acceptability of a comprehensive survivorship lifestyle intervention addressing nutrition, exercise, sleep health, and stress management. The intervention integrates the BfedBwell survivorship nutrition program with the BfitBwell clinical exercise oncology program. The augmented BfedBwell program includes: (1) a core education curriculum, (2) 1:1 counseling with a registered dietitian, (3) behavioral skills development, (4) group support, and (5) commercially available wearable technology and smart scales for self-monitoring of physical activity, sleep, and body weight.

Detailed description

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 single-arm study of the augmented BfedBwell + BfitBwell interventions. Feasibility and acceptability of integrating commercially-available wearable technology and smart scales will be evaluated. The study will also explore preliminary changes in sleep quality, perceived stress, and physiological indicators of stress and immune function.

Conditions

• Cancer Survivorship
• Overweight , Obesity

Interventions

Type	Name	Description
BEHAVIORAL	BfedBwell - Core Curriculum	Group-based education sessions based upon guidelines for nutrition and lifestyle behaviors for cancer survivorship
BEHAVIORAL	BfedBwell - 1:1 Counseling	Individual 1:1 counseling sessions with a registered dietitian to review progress and address barriers
BEHAVIORAL	BfedBwell - Behavioral Skills	Group-based behavioral skills development sessions and cooking demonstrations to focus on behavior change techniques (e.g., self-monitoring, goal setting) and nutrition skills (e.g., recipe development, label reading)
BEHAVIORAL	BfedBwell - Group Support	Structured group support sessions to share experiences
BEHAVIORAL	BfedBwell - Technology	Commercially available devices (fitness trackers, smart scales) for self-monitoring of physical activity, sleep, and body weight
BEHAVIORAL	BfitBwell - Clinical Exercise Program	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: 2026-06-01
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2026-03-03
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States