Cancer SurvivorshipNCT06191666
BfedBwell Proof-of-Concept Pilot
A study testing Group-based education and discussion, Individual 1:1 counseling and Group based behavioral skills development and cooking demonstrations in people with Cancer Survivorship and Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer Survivorship, Obesity, Overweight
- What is being tested?
- Group-based education and discussion, Individual 1:1 counseling and Group based behavioral skills development and cooking demonstrations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 16 Dec 2024
- 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 20Show fewer
- 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)
- Not be planning to travel for >2 consecutive weeks or relocate/move during the intervention
- 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 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]
Who cannot join
- 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
Show all 34Show 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, 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 >7.5%, 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 alone
- 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
- 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)
- 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
- 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 American College of Sports Medicine (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: Design and Integration of a Survivorship Nutrition Intervention Into an Established Exercise Oncology Program: the BfedBwell Pilot Intervention
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).
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 + BfitBwell 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 12-week single-arm study of the integrated BfedBwell + BfitBwell 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 evaluate proof-of-concept prior to advancing to efficacy testing.
- Conditions
- Cancer Survivorship, Obesity, Overweight
- Being tested
- Group-based education and discussion, Individual 1:1 counseling, Group based behavioral skills development and cooking demonstrations, BfitBwell
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based education and discussionBehavioural
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)
Individual 1:1 counselingBehavioural
Individual 1:1 counseling sessions (30 minutes each per month, virtual) with an RD to review progress and address barriers
Group based behavioral skills development and cooking demonstrationsBehavioural
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).
BfitBwellBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Group-based education and discussion; Behavioral: Individual 1:1 counseling; Behavioral: Group based behavioral skills development and cooking demonstrations; Behavioral: BfitBwell |
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: 12 weeks
Determine the research protocol adherence feasibility of the BfedBwell nutrition intervention
Adherence will be assessed as [# sessions attended/# sessions provided]
Measured: 12 weeks
Determine the research protocol outcome assessment feasibility of the BfedBwell nutrition intervention
Outcome assessment rates will be assessed as [# completing assessments/# enrolled].
Measured: 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].
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (12)
Assess preliminary 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 weeks
Assess preliminary efficacy for weight loss
Determine the change in weight as measured by digital scale. A lower weight indicates an improvement.
Measured: 12 weeks
Assess preliminary 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 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 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 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 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 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 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 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 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 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 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start5 Feb 2024
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily B Hill, PhD, RDN, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191666
- Sponsor's protocol ID
- 23-1501.cc
- Status last verified
- Feb 2026
- First submitted
- 19 Dec 2023
- Last updated
- 11 Feb 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 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Integration of a Survivorship Nutrition Intervention Into an Established Exercise Oncology Program: the BfedBwell Pilot Intervention
- ClinicalTrials.gov ID
- NCT06191666
- Acronym / sponsor ID
- 23-1501.cc
- Conditions
- Cancer Survivorship, Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 5 Jan 2024 (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.
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).
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 + BfitBwell 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 12-week single-arm study of the integrated BfedBwell + BfitBwell 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 evaluate proof-of-concept prior to advancing to efficacy testing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Survivors | Experimental | Behavioral: Group-based education and discussion, Behavioral: Individual 1:1 counseling, Behavioral: Group based behavioral skills development and cooking demonstrations, Behavioral: BfitBwellCancer 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 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 (34 listed)
- None
- 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
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 |
|---|---|---|
| Group-based education and discussionGroup-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) | Behavioural | Cancer Survivors |
| Individual 1:1 counselingIndividual 1:1 counseling sessions (30 minutes each per month, virtual) with an RD to review progress and address barriers | Behavioural | Cancer Survivors |
| Group based behavioral skills development and cooking demonstrationsGroup-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). | Behavioural | Cancer Survivors |
| BfitBwellThis 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. | Behavioural | Cancer Survivors |
Primary outcome
Determine the research protocol recruitment feasibility of the BfedBwell nutrition intervention
Time frame: 12 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: 12 weeks
Adherence will be assessed as [# sessions attended/# sessions provided]
Determine the research protocol outcome assessment feasibility of the BfedBwell nutrition intervention
Time frame: 12 weeks
Outcome assessment rates will be assessed as [# completing assessments/# enrolled].
Determine the research protocol retention feasibility of the BfedBwell nutrition intervention
Time frame: 12 weeks
Retention will be assessed as [# of participants who complete the 12-week intervention/# of participants enrolled].
Determine the intervention feasibility by program delivery staff using Feasibility of Intervention Measure (FIM)
Time frame: 12 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 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 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 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 >0 indicating good acceptability.
Determine the intervention acceptability by participants and program providers during qualitative interviews
Time frame: 12 weeks
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 secondary outcomes
Assess preliminary efficacy for increased adherence to lifestyle recommendations
Time frame: 12 weeks
Assess preliminary efficacy for weight loss
Time frame: 12 weeks
Assess preliminary efficacy for improvement in body composition
Time frame: 12 weeks
Measure the change in systolic blood pressure to determine improved cardiometabolic health
Time frame: 12 weeks
Measure the change in diastolic blood pressure to determine improved cardiometabolic health
Time frame: 12 weeks
Measure changes in total cholesterol to determine improved cardiometabolic health
Time frame: 12 weeks
Measure changes in LDL cholesterol to determine improved cardiometabolic health
Time frame: 12 weeks
Measure changes in HDL cholesterol to determine improved cardiometabolic health
Time frame: 12 weeks
Measure changes in triglycerides to determine improved cardiometabolic health
Time frame: 12 weeks
Measure changes in glucose to determine improved cardiometabolic health
Time frame: 12 weeks
Measure changes in insulin to determine improved cardiometabolic health
Time frame: 12 weeks
Intervention safety determined by number of adverse events
Time frame: 12 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 Feb 2026.
Related trials for Cancer Survivorship
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Active, not recruiting
Virtual Art Therapy Assisted Re-Integration to Improve Biopsychosocial Outcomes in Adolescent and Young Adult Cancer Survivors, AVATARS Trial
Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
RecruitingObservational study
Pluvicto Real-world Investigation in Survival in Metastatic CRPC
Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis
Recruiting
At-home Breast Oncology Care Delivered With E-health Solutions
Patient Engagement, Patient Activation
Recruiting
Improving Adherence to Chronic Disease Medication Regimens Among Patients With Recently Diagnosed Cancer
Cancer
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 Group-based education and discussion, Individual 1:1 counseling and Group based behavioral skills development and cooking demonstrations in people with Cancer Survivorship and Obesity, 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 20 inclusion and 34 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 Feb 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: 12 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 Feb 2026.