BfedBwell Optimization Pilot (NCT06184256) | Clinical Trial Compass
CompletedNot Applicable
BfedBwell Optimization Pilot
United States73 participantsStarted 2025-02-05
Plain-language summary
Using the Multiphase Optimization Strategy (MOST) framework, an engineering-based approach to efficiently and systematically develop, optimize, and evaluate behavioral interventions, this study will test three components: (1) 1:1 counseling with a registered dietitian, (2) behavioral skills development, and (3) group support for delivery alongside a core nutrition curriculum within a clinical exercise oncology program.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Men and women
. Age ≥ 18 years
. Speak English
. Self-reported previous experience in the delivery of nutrition, exercise, or behavioral weight management programs
. Men and women
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the research protocol recruitment feasibility of the BfedBwell nutrition intervention
Timeframe: 24 weeks
2
Determine the research protocol adherence feasibility of the BfedBwell nutrition intervention
Timeframe: 24 weeks
3
Determine the research protocol outcome assessment feasibility of the BfedBwell nutrition intervention
Timeframe: 24 weeks
4
Determine the research protocol retention feasibility of the BfedBwell nutrition intervention
Timeframe: 24 weeks
5
Determine the intervention acceptability by participants during focus groups
Timeframe: 24 weeks
6
Determine the intervention feasibility by program delivery staff using Feasibility of Intervention Measure (FIM)
Timeframe: 12 and 24 weeks
7
Determine the intervention acceptability by program delivery staff using Acceptability of Intervention Measure (AIM)
5. Willing to attend weekly small group education sessions and some, none, or all of the following: monthly behavioral skills development sessions, weekly group support sessions and/or monthly 1:1 counseling held by a registered dietitian (RD)
6. Willing to attend up to two BfitBwell exercise sessions (one in person, one virtual) per week for first 12 weeks then once monthly in person and once weekly virtual sessions for second 12 weeks
7. 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 \[i.e., \<150 minutes moderate/vigorous activity per week via self-report on Godin-Shephard Leisure-Time Physical Activity Questionnaire\]
. 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
Timeframe: 12 and 24 weeks
8
Determine the intervention acceptability by program delivery staff using Intervention Appropriateness Measure (IAM)
Timeframe: 12 and 24 weeks
9
Determine the intervention acceptability by participants using the Net Promoter Score (NPS)