BfedBwell INSPIRE Pilot

NCT07446595 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-09-03

No results posted yet for this study

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.

Conditions

  • Cancer Survivorship
  • Overweight , Obesity

Interventions

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

Sponsors & Collaborators

  • American Institute for Cancer Research

    collaborator OTHER
  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Emily Hill, PhD, RDN · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-11
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07446595 on ClinicalTrials.gov