Actively Recruiting
BfedBwell INSPIRE Pilot
Led by University of Colorado, Denver · Updated on 2026-04-28
25
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
A
American Institute for Cancer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
BfedBwell INSPIRE Pilot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years
- BMI 25-45 kg/m2
- History of adult cancer diagnosed within the past 10 years
- Completed active cancer treatment at least 3 months ago or in stable maintenance therapy
- Have or willing to establish a primary care provider for medical clearance
- Able and willing to participate in supervised exercise as assessed by screening questionnaires
- Speak English
- Have access to a computer or smartphone with internet for virtual meetings and coaching
- Live or work within 30 miles of the study center (exceptions possible)
- No planned major surgery, long travel (>2 weeks), or relocation during the 6-month intervention
- No nicotine or tobacco use within the past 6 months
- Agree to avoid nutritional supplements except those prescribed by a physician during the study
- Capable and willing to provide informed consent and understand study requirements
- Willing to attend scheduled group education, behavioral skills, support, counseling, and exercise sessions
- Not meeting dietary or physical activity guidelines; exceptions possible for motivated individuals
You will not qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher
- Currently undergoing or recently completed chemotherapy, radiation, immunotherapy, or surgery within specified timeframes unless approved by the investigator
- More than 10 years since active or maintenance therapy completion
- Plans to relocate or travel extensively (>2 weeks) within next 6 months
- For females: currently pregnant, lactating, recently pregnant, or planning pregnancy within 18 months without reliable contraception
- Major surgery within past 3 months or planned elective surgery during the study
- Treatments affecting digestion or metabolism (e.g., surgical loss of digestive organs)
- Recent serious cardiovascular events or symptoms suggestive of heart disease
- Uncontrolled hypertension or abnormal resting heart rate
- Diabetes unless well controlled on specified medications
- Uncontrolled thyroid disorders
- High triglycerides or LDL cholesterol as measured during screening
- Other significant metabolic or chronic health problems impacting safe participation
- Recent start of certain medications affecting metabolism or weight
- Use of medications impacting appetite or weight except specific cancer treatments
- Recent or sustained use of systemic glucocorticoids unless replacement therapy
- Previous obesity surgery or devices unless removed more than 1 year prior
- Recent or planned participation in other nutrition, weight loss, or exercise programs or trials
- Nicotine or tobacco use in past 6 months
- Current alcohol or substance abuse
- History or suspicion of eating disorders requiring further assessment
- Severe depression or psychiatric illness interfering with participation
- Medical or physical limitations preventing safe exercise
- Cognitive inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
M
Melissa Mamele, MS, RD, CSCS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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