SurvivorshipNCT06184256
BfedBwell Optimization Pilot
A study testing BfedBwell - Core Curriculum, BfedBwell - 1:1 Counseling and BfedBwell - Behavioral Skills in people with Survivorship and Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Survivorship, Cancer
- What is being tested?
- BfedBwell - Core Curriculum, BfedBwell - 1:1 Counseling and BfedBwell - Behavioral Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2025to 5 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 23Show fewer
- 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
- 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
- Capable and willing to give informed consent and understand exclusion criteria
- 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]
Who cannot join
- 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
Show all 35Show fewer
- 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 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Cancer Center
Aurora, Colorado, 80045
About this study
Official title: BfedBwell: Multiphase Optimization Strategy Pilot Trial of a Nutrition Intervention for Cancer Survivors With Overweight and Obesity
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.
Read the detailed description
Individuals with experience in delivery of lifestyle (e.g., diet, physical activity) interventions will be recruited to deliver and evaluate the integrated BfedBwell intervention.
Cancer survivors with overweight/obesity who have completed active treatment will be recruited from the University of Colorado Anschutz Medical Campus for participation in a 6-month cluster-randomized 2^3-factorial pilot optimization trial of the BfedBwell intervention. Feasibility and acceptability will be evaluated. Exploration of intervention effect on adherence to cancer survivorship guidelines, body composition, and cardiometabolic indicators of health will be used to determine a set of components that demonstrate patterns of efficacy.
- Conditions
- Survivorship, Cancer
- Being tested
- BfedBwell - Core Curriculum, BfedBwell - 1:1 Counseling, BfedBwell - Behavioral Skills, BfedBwell - Group Support, Program delivery
- Keywords
- Overweight, Obesity, Diet, food, and nutrition, Exercise, Healthy lifestyle behaviors, Cancer
- Medical subject headings
- Neoplasms, Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BfedBwell - Core CurriculumBehavioural
12-week core nutrition education curriculum + 12-week tapered maintenance curriculum
BfedBwell - 1:1 CounselingBehavioural
Individual 1:1 counseling sessions with a registered dietitian
BfedBwell - Behavioral SkillsBehavioural
Group-based behavioral skills development sessions
BfedBwell - Group SupportBehavioural
Structured group support sessions
Program deliveryBehavioural
Delivery and evaluation of one or more intervention components
| Study group | Role | What they receive |
|---|---|---|
| Core Curriculum | Experimental | Participants will receive core curriculum Receives: Behavioral: BfedBwell - Core Curriculum |
| Core Curriculum and Group Support | Experimental | Participants will receive core curriculum and group support Receives: Behavioral: BfedBwell - Core Curriculum; Behavioral: BfedBwell - Group Support |
| Core Curriculum and Behavioral Skills | Experimental | Participants will receive core curriculum and behavioral skills Receives: Behavioral: BfedBwell - Core Curriculum; Behavioral: BfedBwell - Behavioral Skills |
| Core Curriculum, Behavioral Skills, and Group Support | Experimental | Participants will receive core curriculum, behavioral skills, and group support Receives: Behavioral: BfedBwell - Core Curriculum; Behavioral: BfedBwell - Behavioral Skills; Behavioral: BfedBwell - Group Support |
| Core Curriculum and 1:1 Counseling | Experimental | Participants will receive core curriculum and 1:1 counseling Receives: Behavioral: BfedBwell - Core Curriculum; Behavioral: BfedBwell - 1:1 Counseling |
| Core Curriculum,1:1 Counseling, and Group Support | Experimental | Participants will receive core curriculum, 1:1 counseling, and group support Receives: Behavioral: BfedBwell - Core Curriculum; Behavioral: BfedBwell - 1:1 Counseling; Behavioral: BfedBwell - Group Support |
| Core Curriculum, 1:1 Counseling, and Behavioral Skills | Experimental | Participants will receive core curriculum, 1:1 counseling, and behavioral skills Receives: Behavioral: BfedBwell - Core Curriculum; Behavioral: BfedBwell - 1:1 Counseling; Behavioral: BfedBwell - Behavioral Skills |
| Core Curriculum, 1:1 Counseling, Behavioral Skills, and Group Support | Experimental | Participants will receive core curriculum, 1:1 counseling, behavioral skills, and group support Receives: Behavioral: BfedBwell - Core Curriculum; Behavioral: BfedBwell - 1:1 Counseling; Behavioral: BfedBwell - Behavioral Skills; Behavioral: BfedBwell - Group Support |
| Program Provider | Experimental | Providers will deliver and evaluate one or more components of the diet or exercise interventions Receives: Behavioral: Program delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 weeks
Determine the research protocol outcome assessment feasibility of the BfedBwell nutrition intervention
Outcome assessment rates will be assessed as [# completing assessments/# enrolled].
Measured: 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].
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 \&amp;amp;gt;0 indicating good acceptability.
Measured: 12 and 24 weeks
Secondary outcomes (12)
Identify a set of components that demonstrate patterns of efficacy for increased adherence to lifestyle recommendations
Determine the change in adherence to cancer survivorship guidelines as measured by World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) scoring criteria. Scores range from 0 to 7 points. A higher score reflects greater adherence to the recommendations.
Measured: 12 and 24 weeks
Identify a set of components that demonstrate patterns of efficacy for weight loss
Determine the change in weight as measured by digital scale. A lower weight indicates an improvement.
Measured: 12 and 24 weeks
Identify a set of components that demonstrate patterns of efficacy for improvement in body composition
Determine the change in body composition as measured by dual x-ray absorptiometry (DXA). A lower body fat percentage indicates an improvement.
Measured: 12 and 24 weeks
Measure the change in systolic blood pressure to determine improved cardiometabolic health
Systolic blood pressure will be measured at specific time points during the trial. A lower systolic blood pressure indicates an improvement.
Measured: 12 and 24 weeks
Measure the change in diastolic blood pressure to determine improved cardiometabolic health
Diastolic blood pressure will be measured at specific time points during the trial. A lower diastolic blood pressure indicates an improvement.
Measured: 12 and 24 weeks
Measure changes in total cholesterol to determine improved cardiometabolic health
Total cholesterol will be measured at specific time points during the trial. A lower total cholesterol indicates an improvement.
Measured: 12 and 24 weeks
Measure changes in LDL cholesterol to determine improved cardiometabolic health
LDL cholesterol will be measured at specific time points during the trial. A lower LDL cholesterol indicates an improvement.
Measured: 12 and 24 weeks
Measure changes in HDL cholesterol to determine improved cardiometabolic health
HDL cholesterol will be measured at specific time points during the trial. A higher HDL cholesterol indicates an improvement.
Measured: 12 and 24 weeks
Measure changes in triglycerides to determine improved cardiometabolic health
Triglycerides will be measured at specific time points during the trial. Lower triglycerides indicate an improvement.
Measured: 12 and 24 weeks
Measure changes in glucose to determine improved cardiometabolic health
Glucose levels will be measured at specific time points during the trial. Lower glucose levels indicate an improvement.
Measured: 12 and 24 weeks
Measure changes in insulin to determine improved cardiometabolic health
Insulin levels will be measured at specific time points during the trial. Lower insulin levels indicate an improvement.
Measured: 12 and 24 weeks
Intervention safety determined by number of adverse events
Overall rates of study-related mild, moderate, severe, and serious adverse events (AEs) will be tracked by study staff.
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start5 Feb 2025
- Primary completion5 May 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Emily B Hill, PhD, RDN, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184256
- Sponsor's protocol ID
- 23-2151.cc
- Other IDs
- 1K99CA287061-01
- Status last verified
- Jun 2026
- First submitted
- 13 Dec 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BfedBwell: Multiphase Optimization Strategy Pilot Trial of a Nutrition Intervention for Cancer Survivors With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT06184256
- Acronym / sponsor ID
- 23-2151.cc
- Conditions
- Survivorship, Cancer
- Keywords
- Overweight, Obesity, Diet, food, and nutrition, Exercise, Healthy lifestyle behaviors, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Individuals with experience in delivery of lifestyle (e.g., diet, physical activity) interventions will be recruited to deliver and evaluate the integrated BfedBwell intervention.
Cancer survivors with overweight/obesity who have completed active treatment will be recruited from the University of Colorado Anschutz Medical Campus for participation in a 6-month cluster-randomized 2^3-factorial pilot optimization trial of the BfedBwell intervention. Feasibility and acceptability will be evaluated. Exploration of intervention effect on adherence to cancer survivorship guidelines, body composition, and cardiometabolic indicators of health will be used to determine a set of components that demonstrate patterns of efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Core Curriculum | Experimental | Behavioral: BfedBwell - Core CurriculumParticipants will receive core curriculum |
| Core Curriculum and Group Support | Experimental | Behavioral: BfedBwell - Core Curriculum, Behavioral: BfedBwell - Group SupportParticipants will receive core curriculum and group support |
| Core Curriculum and Behavioral Skills | Experimental | Behavioral: BfedBwell - Core Curriculum, Behavioral: BfedBwell - Behavioral SkillsParticipants will receive core curriculum and behavioral skills |
| Core Curriculum, Behavioral Skills, and Group Support | Experimental | Behavioral: BfedBwell - Core Curriculum, Behavioral: BfedBwell - Behavioral Skills, Behavioral: BfedBwell - Group SupportParticipants will receive core curriculum, behavioral skills, and group support |
| Core Curriculum and 1:1 Counseling | Experimental | Behavioral: BfedBwell - Core Curriculum, Behavioral: BfedBwell - 1:1 CounselingParticipants will receive core curriculum and 1:1 counseling |
| Core Curriculum,1:1 Counseling, and Group Support | Experimental | Behavioral: BfedBwell - Core Curriculum, Behavioral: BfedBwell - 1:1 Counseling, Behavioral: BfedBwell - Group SupportParticipants will receive core curriculum, 1:1 counseling, and group support |
| Core Curriculum, 1:1 Counseling, and Behavioral Skills | Experimental | Behavioral: BfedBwell - Core Curriculum, Behavioral: BfedBwell - 1:1 Counseling, Behavioral: BfedBwell - Behavioral SkillsParticipants will receive core curriculum, 1:1 counseling, and behavioral skills |
| Core Curriculum, 1:1 Counseling, Behavioral Skills, and Group Support | Experimental | Behavioral: BfedBwell - Core Curriculum, Behavioral: BfedBwell - 1:1 Counseling, Behavioral: BfedBwell - Behavioral Skills, Behavioral: BfedBwell - Group SupportParticipants will receive core curriculum, 1:1 counseling, behavioral skills, and group support |
| Program Provider | Experimental | Behavioral: Program deliveryProviders will deliver and evaluate one or more components of the diet or exercise interventions |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (35 listed)
- None
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BfedBwell - Core Curriculum12-week core nutrition education curriculum + 12-week tapered maintenance curriculum | Behavioural | Core Curriculum, Core Curriculum and 1:1 Counseling, Core Curriculum and Behavioral Skills, Core Curriculum and Group Support, Core Curriculum, 1:1 Counseling, Behavioral Skills, and Group Support, Core Curriculum, 1:1 Counseling, and Behavioral Skills, Core Curriculum, Behavioral Skills, and Group Support, Core Curriculum,1:1 Counseling, and Group Support |
| BfedBwell - 1:1 CounselingIndividual 1:1 counseling sessions with a registered dietitian | Behavioural | Core Curriculum and 1:1 Counseling, Core Curriculum, 1:1 Counseling, Behavioral Skills, and Group Support, Core Curriculum, 1:1 Counseling, and Behavioral Skills, Core Curriculum,1:1 Counseling, and Group Support |
| BfedBwell - Behavioral SkillsGroup-based behavioral skills development sessions | Behavioural | Core Curriculum and Behavioral Skills, Core Curriculum, 1:1 Counseling, Behavioral Skills, and Group Support, Core Curriculum, 1:1 Counseling, and Behavioral Skills, Core Curriculum, Behavioral Skills, and Group Support |
| BfedBwell - Group SupportStructured group support sessions | Behavioural | Core Curriculum and Group Support, Core Curriculum, 1:1 Counseling, Behavioral Skills, and Group Support, Core Curriculum, Behavioral Skills, and Group Support, Core Curriculum,1:1 Counseling, and Group Support |
| Program deliveryDelivery and evaluation of one or more intervention components | Behavioural | Program Provider |
Primary outcome
Determine the research protocol recruitment feasibility of the BfedBwell nutrition intervention
Time frame: 24 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 BfedBwell nutrition intervention
Time frame: 24 weeks
Adherence will be assessed as [# sessions attended/# sessions provided] for each BfedBwell component.
Determine the research protocol outcome assessment feasibility of the BfedBwell nutrition intervention
Time frame: 24 weeks
Outcome assessment rates will be assessed as [# completing assessments/# enrolled].
Determine the research protocol retention feasibility of the BfedBwell nutrition intervention
Time frame: 24 weeks
Retention will be assessed as [# of participants who complete the 24-week intervention/# of participants randomized].
Determine the intervention acceptability by participants during focus groups
Time frame: 24 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 feasibility by program delivery staff using Feasibility of Intervention Measure (FIM)
Time frame: 12 and 24 weeks
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.
Determine the intervention acceptability by program delivery staff using Acceptability of Intervention Measure (AIM)
Time frame: 12 and 24 weeks
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.
Determine the intervention acceptability by program delivery staff using Intervention Appropriateness Measure (IAM)
Time frame: 12 and 24 weeks
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.
Determine the intervention acceptability by participants using the Net Promoter Score (NPS)
Time frame: 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 \&amp;amp;gt;0 indicating good acceptability.
12 secondary outcomes
Identify a set of components that demonstrate patterns of efficacy for increased adherence to lifestyle recommendations
Time frame: 12 and 24 weeks
Identify a set of components that demonstrate patterns of efficacy for weight loss
Time frame: 12 and 24 weeks
Identify a set of components that demonstrate patterns of efficacy for improvement in body composition
Time frame: 12 and 24 weeks
Measure the change in systolic blood pressure to determine improved cardiometabolic health
Time frame: 12 and 24 weeks
Measure the change in diastolic blood pressure to determine improved cardiometabolic health
Time frame: 12 and 24 weeks
Measure changes in total cholesterol to determine improved cardiometabolic health
Time frame: 12 and 24 weeks
Measure changes in LDL cholesterol to determine improved cardiometabolic health
Time frame: 12 and 24 weeks
Measure changes in HDL cholesterol to determine improved cardiometabolic health
Time frame: 12 and 24 weeks
Measure changes in triglycerides to determine improved cardiometabolic health
Time frame: 12 and 24 weeks
Measure changes in glucose to determine improved cardiometabolic health
Time frame: 12 and 24 weeks
Measure changes in insulin to determine improved cardiometabolic health
Time frame: 12 and 24 weeks
Intervention safety determined by number of adverse events
Time frame: 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Exercise and Nutrition for Older Cancer Survivors and Their Support Person: The Vitality Study
Cancer Survivorship
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
Recruiting
A Resilience-Based Approach to Improve Long-term Quality of Life in Post-treatment Lymphoma Survivorship
Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily B Hill, PhD, RDN principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BfedBwell - Core Curriculum, BfedBwell - 1:1 Counseling and BfedBwell - Behavioral Skills in people with Survivorship and Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the research protocol recruitment feasibility of the BfedBwell nutrition intervention (time frame: 24 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.