BfedBwell Optimization Pilot (NCT06184256) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
BfedBwell Optimization Pilot
United States74 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 range18 Years – 75 Years
SexALL
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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
✕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
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)
✕. 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
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)