BfedBwell Proof-of-Concept Pilot

NCT06191666 | Completed DMC

• 1 other identifier: 23-1501.cc
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This single-arm proof-of-concept pilot will assess the feasibility and acceptability of integrating a survivorship nutrition intervention (BfedBwell) into an existing clinical exercise oncology program (BfitBwell).

Conditions

Cancer Survivorship; Overweight; Obesity

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.

  12 weeks

• Determine the research protocol adherence feasibility of the BfedBwell nutrition intervention

  Adherence will be assessed as \[# sessions attended/# sessions provided\]

  12 weeks

• Determine the research protocol outcome assessment feasibility of the BfedBwell nutrition intervention

  Outcome assessment rates will be assessed as \[# completing assessments/# enrolled\].

  12 weeks

• Determine the research protocol retention feasibility of the BfedBwell nutrition intervention

  Retention will be assessed as \[# of participants who complete the 12-week intervention/# of participants enrolled\].

  12 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 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 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 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 weeks

• Determine the intervention acceptability by participants and program providers during qualitative interviews

  1:1 interviews will be conducted with all program delivery staff and BfedBwell survivorship nutrition intervention participants after the 12-week intervention to assess acceptability of intervention and provide feedback for continued refinement.

  12 weeks

Secondary Outcomes (12)

• Assess preliminary efficacy for increased adherence to lifestyle recommendations

  12 weeks

• Assess preliminary efficacy for weight loss

  12 weeks

• Assess preliminary efficacy for improvement in body composition

  12 weeks

• Measure the change in systolic blood pressure to determine improved cardiometabolic health

  12 weeks

• Measure the change in diastolic blood pressure to determine improved cardiometabolic health

  12 weeks

Study Arms (1)

Cancer Survivors

EXPERIMENTAL

Cancer survivors with ow/ob who have completed active treatment will take part in a single-arm 12-week feasibility/acceptability/proof-of-concept study incorporating group nutrition education and discussion, skills development sessions and cooking demonstrations, and 1:1 counseling with a dietitian.

Behavioral: Group-based education and discussion; Behavioral: Individual 1:1 counseling; Behavioral: Group based behavioral skills development and cooking demonstrations; Behavioral: BfitBwell

Interventions

BfitBwell BEHAVIORAL

This program consists of a supervised exercise program developed by a cancer exercise specialist and based upon the NCCN guidelines for physical activity during cancer survivorship and other recommendations.

Cancer Survivors

Group-based education and discussion BEHAVIORAL

Group-based education and discussion (60 minutes each per week, virtual and in-person) based upon guidelines for nutrition for cancer survivorship (e.g., follow a plant-based diet with a variety of vegetables, fruits, whole grains, and legumes; limit alcohol intake; reduce consumption of highly processed foods and foods high in salt; achieve a weekly calorie deficit of approximately 3500 kcal for weight loss)

Cancer Survivors

Individual 1:1 counseling BEHAVIORAL

Individual 1:1 counseling sessions (30 minutes each per month, virtual) with an RD to review progress and address barriers

Cancer Survivors

Group based behavioral skills development and cooking demonstrations BEHAVIORAL

Group-based behavioral skills development sessions and cooking demonstrations (60-90 minutes each per month, in-person) to focus on behavior change techniques (e.g., self-monitoring, goal setting) and nutrition skills (e.g., recipe development, label reading).

Cancer Survivors

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• Body Mass Index 25-45 kg/m2
• Completion of active cancer therapy with curative intent at least three months and no more than five years prior to enrollment; ongoing hormone therapy is permitted
• 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 guidelines (note: any positive responses will trigger a required physician clearance form)
• Speak English
• Have access to a computer or smart phone and Internet
• Live or work within 30 miles of the Anschutz Health and Wellness Center (exceptions may be made at the discretion of the study PI on a case-by-case basis for highly motivated subjects)

You may not qualify if:

• Willing to attend weekly small group sessions (behavioral skills development and/or group support) and/or 1:1 counseling held by a registered dietitian (RD) and attend up to two BfitBwell exercise sessions per week
• Not meeting dietary guidelines \[i.e., Healthy Eating Index (HEI) score \<80 as assessed via National Cancer Institute Diet History Questionnaire III (NCI DHQ III) food frequency questionnaire\] 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 cancer therapy or within 3 months of completion of surgery, chemotherapy, or radiation treatment
• Greater than 5 years post-active 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
• Any major surgery within the past 3 months, including mastectomy

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Counseling

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Emily B Hill, PhD, RDN

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: February 5, 2024
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

US (1)