BfedBwell Optimization Pilot

Study Overview
=================
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.

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 12-week 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.

Official Title
-----------------
BfedBwell: Multiphase Optimization Strategy Pilot Trial of a Nutrition Intervention for Cancer Survivors With Overweight and Obesity

Conditions
-----------------
Survivorship, Cancer

Intervention / Treatment
-----------------
* Behavioral: BfedBwell - Core Curriculum
* Behavioral: BfedBwell - 1:1 Counseling
* Behavioral: BfedBwell - Behavioral Skills
* Behavioral: BfedBwell - Group Support
* Behavioral: Program delivery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 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 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 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 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] Exclusion Criteria: 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 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 ACSM guidelines Are cognitively unable to consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cluster 1<br>Participants will receive core curriculum | Behavioral: BfedBwell - Core Curriculum<br>* 12-week core nutrition education curriculum<br>|
| Experimental: Cluster 2<br>Participants will receive core curriculum and group support | Behavioral: BfedBwell - Core Curriculum<br>* 12-week core nutrition education curriculum<br>Behavioral: BfedBwell - Group Support<br>* Structured group support sessions<br>|
| Experimental: Cluster 3<br>Participants will receive core curriculum and behavioral skills | Behavioral: BfedBwell - Core Curriculum<br>* 12-week core nutrition education curriculum<br>Behavioral: BfedBwell - Behavioral Skills<br>* Group-based behavioral skills development sessions<br>|
| Experimental: Cluster 4<br>Participants will receive core curriculum, behavioral skills, and group support | Behavioral: BfedBwell - Core Curriculum<br>* 12-week core nutrition education curriculum<br>Behavioral: BfedBwell - Behavioral Skills<br>* Group-based behavioral skills development sessions<br>Behavioral: BfedBwell - Group Support<br>* Structured group support sessions<br>|
| Experimental: Cluster 5<br>Participants will receive core curriculum and 1:1 counseling | Behavioral: BfedBwell - Core Curriculum<br>* 12-week core nutrition education curriculum<br>Behavioral: BfedBwell - 1:1 Counseling<br>* Individual 1:1 counseling sessions with a registered dietitian<br>|
| Experimental: Cluster 6<br>Participants will receive core curriculum, 1:1 counseling, and group support | Behavioral: BfedBwell - Core Curriculum<br>* 12-week core nutrition education curriculum<br>Behavioral: BfedBwell - 1:1 Counseling<br>* Individual 1:1 counseling sessions with a registered dietitian<br>Behavioral: BfedBwell - Group Support<br>* Structured group support sessions<br>|
| Experimental: Cluster 7<br>Participants will receive core curriculum, 1:1 counseling, and behavioral skills | Behavioral: BfedBwell - Core Curriculum<br>* 12-week core nutrition education curriculum<br>Behavioral: BfedBwell - 1:1 Counseling<br>* Individual 1:1 counseling sessions with a registered dietitian<br>Behavioral: BfedBwell - Behavioral Skills<br>* Group-based behavioral skills development sessions<br>|
| Experimental: Cluster 8<br>Participants will receive core curriculum, 1:1 counseling, behavioral skills, and group support | Behavioral: BfedBwell - Core Curriculum<br>* 12-week core nutrition education curriculum<br>Behavioral: BfedBwell - 1:1 Counseling<br>* Individual 1:1 counseling sessions with a registered dietitian<br>Behavioral: BfedBwell - Behavioral Skills<br>* Group-based behavioral skills development sessions<br>Behavioral: BfedBwell - Group Support<br>* Structured group support sessions<br>|
| Experimental: Program Provider<br>Providers will deliver and evaluate one or more components of the diet or exercise interventions | Behavioral: Program delivery<br>* Delivery and evaluation of one or more intervention components<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] for each BfedBwell component. | 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 randomized]. | 12 weeks | 
| Determine the intervention feasibility by program delivery staff using FIM | Upon completion of the intervention, program delivery staff will be asked to complete the Feasibility of Intervention Measure (FIM). | 12 weeks | 
| Determine the intervention acceptability by program delivery staff using AIM | Upon completion of the intervention, program delivery staff will be asked to complete the Acceptability of Intervention Measure (AIM). | 12 weeks | 
| Determine the intervention acceptability by program delivery staff using IAM | Upon completion of the intervention, program delivery staff will be asked to complete the Intervention Appropriateness Measure (IAM). | 12 weeks | 
| Determine the intervention acceptability by participants using the NPS | Participants will be asked to complete weekly ratings using the Net Promoter Score (NPS). | 12 weeks | 
| Determine the intervention acceptability by participants during focus groups | Participants will be asked to participate in a 60-minute focus group to provide qualitative feedback regarding their experience and satisfaction with the intervention. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 
| Identify a set of components that demonstrate patterns of efficacy for weight loss | Determine the change in weight as measured by digital scale | 12 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) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overweight, Obese