BfedBwell Optimization Pilot
BfedBwell: Multiphase Optimization Strategy Pilot Trial of a Nutrition Intervention for Cancer Survivors With Overweight and Obesity
2 other identifiers
interventional
73
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2023
CompletedFirst Posted
Study publicly available on registry
December 28, 2023
CompletedStudy Start
First participant enrolled
February 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
May 18, 2026
May 1, 2026
1.4 years
December 13, 2023
May 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Determine the research protocol recruitment feasibility of the BfedBwell nutrition intervention
Recruitment will be assessed as the number of adults screened and the proportion of eligible screens who enroll.
24 weeks
Determine the research protocol adherence feasibility of the BfedBwell nutrition intervention
Adherence will be assessed as \[# sessions attended/# sessions provided\] for each BfedBwell component.
24 weeks
Determine the research protocol outcome assessment feasibility of the BfedBwell nutrition intervention
Outcome assessment rates will be assessed as \[# completing assessments/# enrolled\].
24 weeks
Determine the research protocol retention feasibility of the BfedBwell nutrition intervention
Retention will be assessed as \[# of participants who complete the 24-week intervention/# of participants randomized\].
24 weeks
Determine the intervention acceptability by participants during focus groups
Participants will be asked to participate in a 90-minute focus group to provide qualitative feedback regarding their experience and satisfaction with the intervention.
24 weeks
Determine the intervention feasibility by program delivery staff using Feasibility of Intervention Measure (FIM)
Upon completion of the intervention, program delivery staff will be asked to complete the Feasibility of Intervention Measure (FIM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention feasibility.
12 and 24 weeks
Determine the intervention acceptability by program delivery staff using Acceptability of Intervention Measure (AIM)
Upon completion of the intervention, program delivery staff will be asked to complete the Acceptability of Intervention Measure (AIM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention acceptability.
12 and 24 weeks
Determine the intervention acceptability by program delivery staff using Intervention Appropriateness Measure (IAM)
Upon completion of the intervention, program delivery staff will be asked to complete the Intervention Appropriateness Measure (IAM). A Likert scale from 1 (completely disagree) to 5 (completely agree) is used for each question; higher scores indicate greater intervention appropriateness.
12 and 24 weeks
Determine the intervention acceptability by participants using the Net Promoter Score (NPS)
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.
12 and 24 weeks
Secondary Outcomes (12)
Identify a set of components that demonstrate patterns of efficacy for increased adherence to lifestyle recommendations
12 and 24 weeks
Identify a set of components that demonstrate patterns of efficacy for weight loss
12 and 24 weeks
Identify a set of components that demonstrate patterns of efficacy for improvement in body composition
12 and 24 weeks
Measure the change in systolic blood pressure to determine improved cardiometabolic health
12 and 24 weeks
Measure the change in diastolic blood pressure to determine improved cardiometabolic health
12 and 24 weeks
- +7 more secondary outcomes
Study Arms (9)
Core Curriculum
EXPERIMENTALParticipants will receive core curriculum
Core Curriculum and Group Support
EXPERIMENTALParticipants will receive core curriculum and group support
Core Curriculum and Behavioral Skills
EXPERIMENTALParticipants will receive core curriculum and behavioral skills
Core Curriculum, Behavioral Skills, and Group Support
EXPERIMENTALParticipants will receive core curriculum, behavioral skills, and group support
Core Curriculum and 1:1 Counseling
EXPERIMENTALParticipants will receive core curriculum and 1:1 counseling
Core Curriculum,1:1 Counseling, and Group Support
EXPERIMENTALParticipants will receive core curriculum, 1:1 counseling, and group support
Core Curriculum, 1:1 Counseling, and Behavioral Skills
EXPERIMENTALParticipants will receive core curriculum, 1:1 counseling, and behavioral skills
Core Curriculum, 1:1 Counseling, Behavioral Skills, and Group Support
EXPERIMENTALParticipants will receive core curriculum, 1:1 counseling, behavioral skills, and group support
Program Provider
EXPERIMENTALProviders will deliver and evaluate one or more components of the diet or exercise interventions
Interventions
Individual 1:1 counseling sessions with a registered dietitian
12-week core nutrition education curriculum + 12-week tapered maintenance curriculum
Group-based behavioral skills development sessions
Structured group support sessions
Delivery and evaluation of one or more intervention components
Eligibility Criteria
You may qualify if:
- For program delivery staff:
- Men and women
- Age ≥ 18 years
- Speak English
- Self-reported previous experience in the delivery of nutrition, exercise, or behavioral weight management programs
- For intervention participants:
- 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
- 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
- +4 more criteria
You may not qualify if:
- 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)
- 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
- 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 \[i.e., \<150 minutes moderate/vigorous activity per week via self-report on Godin-Shephard Leisure-Time Physical Activity Questionnaire\]
- For program delivery staff:
- None
- For intervention participants:
- 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:
- Currently pregnant or lactating
- Pregnant within the past 6 months
- 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
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily B Hill, PhD, RDN
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2023
First Posted
December 28, 2023
Study Start
February 5, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
February 1, 2028
Last Updated
May 18, 2026
Record last verified: 2026-05