BfedBwell INSPIRE Pilot

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07446595
Status
Recruiting
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Conditions

  • Cancer Survivorship
  • Overweight , Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BfedBwell - Core Curriculum — BEHAVIORAL
    Group-based education sessions based upon guidelines for nutrition and lifestyle behaviors for cancer survivorship
  • BfedBwell - 1:1 Counseling — BEHAVIORAL
    Individual 1:1 counseling sessions with a registered dietitian to review progress and address barriers
  • BfedBwell - Behavioral Skills — BEHAVIORAL
    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)
  • BfedBwell - Group Support — BEHAVIORAL
    Structured group support sessions to share experiences
  • BfedBwell - Technology — BEHAVIORAL
    Commercially available devices (fitness trackers, smart scales) for self-monitoring of physical activity, sleep, and body weight
  • BfitBwell - Clinical Exercise Program — BEHAVIORAL
    Supervised exercise program developed by a cancer exercise specialist and based upon the NCCN guidelines for physical activity during cancer survivorship and other recommendations

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: BfedBwell INSPIRE Intervention
    Participants will receive a 6-month comprehensive survivorship lifestyle intervention combining nutrition education and counseling with structured exercise programming. The nutrition program includes a core curriculum, 1:1 counseling, behavioral skills, group support, and the use of wearable and remote monitoring devices to support self-monitoring of physical activity, sleep, and body weight.

Primary Outcome Measure

Determine the research protocol recruitment feasibility of the augmented BfedBwell nutrition intervention [ Time Frame: 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer CenterAuroraColorado80045
Emily Hill, PhD, RDN (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
University of Colorado Cancer Center· Aurora, CO

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