BfedBwell INSPIRE Pilot for Cancer Survivors
This study, called the BfedBwell INSPIRE Pilot, is looking at a program designed to help cancer survivors who are overweight or have obesity. The program, called augmented BfedBwell, combines nutrition and exercise guidance. It includes group education, one-on-one counseling with a dietitian, skill-building sessions (like cooking demonstrations), group support, and the use of fitness trackers and smart scales. The study aims to see how easy it is to recruit participants, how well people stick with the program, and how easy it is to collect information. You might be able to join if you are between 18 and 75 years old, have a Body Mass Index (BMI) between 25 and 45 (indicating overweight or obesity), and completed cancer treatment within the last 10 years. The study is currently unclear on its recruitment status.
- Study design
- This is a single-arm pilot study, meaning all participants will receive the augmented BfedBwell intervention. It plans to enroll 25 participants.
- What's involved
- Participants will take part in a 6-month study involving education sessions, counseling, skill development, group support, and using wearable technology.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goals of the study are measured at 24 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07446595
BfedBwell INSPIRE Pilot
Recruiting
NAAges 18–75InterventionalSupportive careUniversity of Colorado, DenverInvestigator-initiated
~25 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:BfedBwell - Core CurriculumBfedBwell - 1:1 CounselingBfedBwell - Behavioral SkillsBfedBwell - Group SupportBfedBwell - TechnologyBfitBwell - Clinical Exercise Program
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the research protocol recruitment feasibility of the augmented BfedBwell nutrition intervention
Measured over 24 weeks
+5 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesColorado1
Study leadership
- Emily Hill, PhD, RDN · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age 18-75 years
BMI 25-45 kg/m2
History of cancer within the past 10 years with a diagnosis of an adulthood cancer of any type
In maintenance or surveillance status, defined as completion of active cancer therapy (e.g., surgery, radiation, chemotherapy, immunotherapy) with curative intent at least 3 months and no more than 10 years prior to enrollment or active surveillance with no treatment; ongoing targeted or hormone therapies ≥3 months prior to intervention start date and/or ongoing maintenance therapy ≥1 year is permitted (exceptions to this timeframe for completion of other therapies can be made on a case-by-case basis by the PI if patients are tolerating therapy without adverse effects and will have completed active treatment or been in stable maintenance treatment prior to the intervention start date)
Have a primary care provider (or are willing to establish care with a primary care provider prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions and who will provide clearance to participate in a nutrition and exercise program
Ability and willingness to participate in a supervised exercise program; with ability assessed by the Physical Activity Readiness Questionnaire (PAR-Q+) and questions based upon National Comprehensive Cancer Network (NCCN) guidelines (note: any positive responses will trigger a required physician clearance form)
Speak English
Have access to a computer or smart phone and Internet to join Zoom meetings, complete questionnaires, and access/download the True Coach virtual exercise coaching sessions
Live or work within 30 miles of the AHWC (exceptions may be made at the discretion of the study PI on a case-by-case basis for highly motivated subjects)
Not be planning for major elective surgery, to travel for \>2 consecutive weeks, or relocate/move during the intervention (\~6 months)
No nicotine or tobacco use within previous 6 months
Agree to refrain from use of all nutritional supplements aside from those prescribed by a physician for the duration of the study
Exclusion
Willing to attend weekly small group education sessions, monthly behavioral skills development sessions, weekly group support sessions, and monthly 1:1 counseling sessions with a registered dietitian (RD)
Willing to attend up to two BfitBwell exercise sessions (one in person supervised, one virtual unsupervised) per week for first 12 weeks then once monthly supervised and once weekly unsupervised virtual sessions for second 12 weeks
Not meeting dietary guidelines \[i.e., Healthy Eating Index (HEI) score \<80 as assessed via NCI DHQ III food frequency questionnaire\] or physical activity guidelines \[i.e., \<150 minutes moderate/vigorous activity per week via self-report on Godin-Shephard Leisure-Time Physical Activity Questionnaire\] (exceptions may be made at the discretion of the study PI on a case-by-case basis for highly motivated subjects)
Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or higher
Actively undergoing chemotherapy, radiation, immunotherapy with curative intent or within 3 months of completion of surgery, chemotherapy, or radiation treatment or recent initiation of targeted/hormonal therapy (\<3 months) or maintenance therapy (\<1 year) unless well-tolerated and deemed acceptable by PI on a case-by-case basis
Greater than 10 years post-active or maintenance therapy
Plans to relocate within the next 6 months
Plans for extended travel (\>2 weeks) within the next 6 months
For females: (1) Currently pregnant or lactating, (2) Pregnant within the past 6 months, (3) Planning to become pregnant in the next 18 months; sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use a reliable means of contraception
Any major surgery within the past 3 months or planned elective surgery during the intervention period, including mastectomy
Have completed treatment that significantly impacts digestion, metabolism, and/or food intake (e.g., surgical loss of esophagus, stomach, colon)
Recent (past 6 months) acute coronary event, unstable angina, coronary revascularization, stroke, or pulmonary embolism
Symptoms suggestive of cardiovascular disease (e.g., chest pain, shortness of breath at rest or with mild exertion, lightheadedness, syncope)
Uncontrolled hypertension, defined as diastolic blood pressure \>100 mmHg, systolic blood pressure \>160 mmHg, or resting heart rate \>100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position (if screening is needed due to lack of updated medical record within previous 12 months)
Diabetes (history of type 1 or type 2 diabetes, hemoglobin A1c ≥6.5%, or fasting glucose ≥126 mg/dL as measured during the screening visit if screening is needed due to lack of updated medical record within previous 12 months) unless well controlled on metformin or DPP-V inhibitor monotherapy with hemoglobin A1c \<8%
History of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen is acceptable
Triglycerides \>500 mg/dL as measured on the screening visit (if screening is needed due to lack of updated medical record within previous 12 months)
LDL cholesterol \>200 mg/dL as measured on the screening visit (if screening is needed due to lack of updated medical record within previous 12 months)
Presence or history of other metabolic or chronic health problems which would impact ability to safely participate in a weight loss intervention involving diet and exercise: significant cardiac arrhythmias or cardiac valvular disease, significant gastrointestinal, pulmonary, renal, musculoskeletal, neurologic, hematologic, or psychiatric disease
Have started lipid-lowering, hypertension, or oral hypoglycemic medication in previous 3 months
Sustained use of prescription or over-the-counter medications known to significantly impact appetite, weight, or energy metabolism (e.g., obesity pharmacotherapeutics agents, appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants) with the exception of anti-endocrine or Her2 directed treatment for breast cancer and standard of care anti-emetic or anti-diarrheal agents.
Sustained use of systemic glucocorticoids (current or in the past 6 months) unless physiologic replacement therapy for adrenal insufficiency
Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed \>1 year before screening, (2) lap banding if the band has been removed \>1 year before screening, (3) intragastric balloon if the balloon has been removed \>1 year before screening, (4) duodenal-jejunal bypass sleeve if the sleeve has been removed \>1 year before screening, or (5) AspireAssist or other endoscopically placed weight loss device if the device has been removed \>1 year before screening
Participation within previous 6 months, current participation in, or planning to participate in any formal nutrition, weight loss, or physical activity programs or clinical trials over the next 6 months
Previous participation the BfitBwell exercise oncology program within the previous 3 years (exceptions may be made at the discretion of the study PI)
Nicotine or tobacco use (current or past 6 months)
Current alcohol or substance abuse as assessed by the Cut down, Annoyed, Guilty, and Eye-Opener (CAGE) questionnaire (note: study PI will follow up if screener raises any concerns of substance abuse to determine final eligibility)
History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score \>20 on the Eating Attitudes Test (EATS-26) or pattern of response on the Questionnaire of Eating and Weight Patterns (QEWP-5) suggestive of possible binge eating disorder or bulimia will require further assessment by the study MD to determine if it is appropriate for the subject to participate in the study
Current severe depression or history of severe depression within the previous year, based on Center for Epidemiologic Studies Depression Scale (CES-D) which in the opinion of the study MD would interfere with ability to adhere to the diet and exercise interventions and provide feedback on the interventions via questionnaires and focus groups
History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the study MD would interfere with ability to adhere to the diet and exercise interventions and provide feedback on the interventions via questionnaires and focus groups
Have medical or physical limitations or contraindications to engaging in physical activity (e.g., severe orthopedic conditions, paralysis) or are considered high-risk based on ACSM guidelines
Are cognitively unable to consent
What this trial measures
- Determine the research protocol recruitment feasibility of the augmented BfedBwell nutrition intervention24 weeks
Recruitment will be assessed as the number of adults screened and the proportion of eligible screens who enroll
- Determine the research protocol adherence feasibility of the augmented BfedBwell nutrition intervention24 weeks
Adherence will be assessed as \[# sessions attended/# sessions provided\]
- Determine the research protocol outcome assessment feasibility of the augmented BfedBwell nutrition intervention24 weeks
Outcome assessment rates will be assessed as \[# completing assessments/# enrolled\]
- Determine the research protocol retention feasibility of the augmented BfedBwell nutrition intervention24 weeks
Retention will be assessed as \[# of participants who complete the 24-week intervention/# of participants enrolled\]
- Determine the intervention acceptability by participants during focus groups24 weeks
Participants will be asked to participate in a 90-minute focus group to provide qualitative feedback regarding their experience and satisfaction with the intervention.
- Determine the intervention acceptability by participants using the Net Promoter Score (NPS)12 and 24 weeks
Participants will be asked to complete weekly ratings using the Net Promoter Score (NPS). Respondents are grouped as follows: 1) promoters (score 9-10) are loyal enthusiasts who will keep referring others and fueling growth, 2) passives (score 7-8) are satisfied but unenthusiastic customers who are vulnerable to competitive offerings, and 3) detractors (score 0-6) are unhappy customers who can impede growth with negative word-of-mouth. The final NPS score is calculated as % promoters - % detractors. NPS scores range from -100 to +100, with scores \>/=0 indicating good acceptability.