Thank you for your interest in our research study! This study will test a new nutrition program for people with a history of cancer, called BfedBwell. This study will look at how the BfedBwell program affects people's dietary patterns and other factors like weight, heart health, and quality of life. We are also interested in how this program fits in with the existing BfitBwell clinical exercise oncology program offered at the Anschutz Health and Wellness Center. Findings from this study will inform other nutrition programs for people with a history of cancer. The nutrition program lasts for 24 weeks (6 months) and your participation will last for about 8 months.
If you choose to participate, you will be randomized to one of eight versions of the BfedBwell nutrition program. Each version involves weekly online group nutrition sessions that last for 1 hour. For the first 3 months, some versions also have other activities that may include one or more of the following: 30-minute weekly online group support sessions, 45-minute monthly one-on-one online counseling with a registered dietitian, and/or 90-120 minute monthly in-person cooking demos. All versions of the program have 60-minute online group nutrition sessions every other week during month 4, and once per month during months 5 and 6.
You will also be enrolled in the BfitBwell program, which includes weekly in-person supervised exercise at the Anschutz Health and Wellness Center and online exercise sessions through the True Coach app. Training sessions will be 45-60 minutes in length and will focus on aerobic, resistance, and flexibility exercises. You will be asked to gradually progress your physical activity level to at least 150 minutes per week of moderate intensity exercise.
We will ask you to provide feedback on these programs through weekly surveys. We will hold in-person visits to measure changes in your diet, physical activity, and health at four time points during the study. These visits will last 2-3 hours. We will also hold a 90-minute focus group over Zoom videoconferencing at the end of the program to ask you more about your experience. Our goal is to assess your satisfaction with the program and identify opportunities to improve it in future versions.
Before you commit to participating in the study, it would be helpful to see if you are likely to qualify to be in the study. To do this, we would like to ask you some eligibility questions, which will include questions about your health history, including questions about your mental health and drug and alcohol use. It should take you about 15-20 minutes to go through these questions. Some of the questions may make you uncomfortable; you do not have to answer any question that you would not like to answer, but without answers to these questions, you will not be eligible to participate in the study. We will use an identification code (rather than your name) on the form used to record your answers. If you do not enroll in this study, we will keep the information we collect during this pre-screening secure. We are also required to give you the number of COMIRB, the Ethics Board that oversees our research: it is 303-724-1055, in case you have any questions or concerns about them.
First, we would like to collect information in order to be able to follow up with you about your participation.
What is your first name?
* must provide value
What is your last name?
* must provide value
What is your mailing address?
Street Address 1 Street Address 2 City State Zip
Home Street Address 1
* must provide value
house number and street
enter apt or unit # here, if applicable
State
* must provide value
Zip Code
* must provide value
What is your preferred email address?
* must provide value
enter 999@9.com if not applicable
What is your preferred phone number?
Phone Number (with area code) Cell, Home, or Work?
Phone number
* must provide value
inlcude area code
Phone type
* must provide value
Cell
Home (landline)
Work
Can you receive text messages to your preferred phone number?
* must provide value
No
Yes
What is your preferred contact method?
* must provide value
Phone
Email
Text
How did you hear about this study?
* must provide value
Which community setting?
* must provide value
Which other email?
* must provide value
Which other method?
* must provide value
Next, please complete the following questions about your background. Your responses are confidential and will only be used in aggregate as required for reporting of characteristics of participants who enroll in our study.
What is today's date?
* must provide value
Today M-D-Y
What is your date of birth?
* must provide value
Today M-D-Y
Calculated age (years)
* must provide value
View equation
Please provide your height in feet and inches (for example 5 feet 8 inches) and weight in pounds (for example 200 pounds).
Height feet inches Weight lbs
Height (feet)
* must provide value
feet
Height (inches)
* must provide value
inches
Weight (lbs)
* must provide value
lbs
View equation
What was your biological sex assigned at birth?
* must provide value
Male
Female
Intersex
None of these describe me
Prefer not to answer
Please describe:
* must provide value
What is your gender identity?
* must provide value
Man
Woman
Non-binary
Transgender
None of these describe me
Prefer not to answer
Please describe:
* must provide value
Which of the following best represents how you think of yourself?
* must provide value
Gay
Lesbian
Straight (not gay or lesbian)
Bisexual
None of these describe me
Prefer not to answer
Are any of these a closer description of how you think of yourself?
* must provide value
Queer
Polysexual, omnisexual, sapiosexual, or pansexual
Asexual
Two-spirit
Have not figured out or are in the process of figuring out your sexuality
Mostly straight, but sometimes attracted to people of your own sex
Do not think of yourself as having sexuality
Do not use labels to identity yourself
No, I mean something else
Don't know/not sure
Please describe:
* must provide value
What race or races do you consider yourself to be? Please select one or more.
* must provide value
Which races do you consider yourself to be?
* must provide value
Please describe:
* must provide value
Do you consider yourself to be Hispanic, Latino, or of Spanish origin?
* must provide value
Please select the highest level of education that you have completed:
* must provide value
Never attended/kindergarten only
Some schooling (elementary/secondary)
High school graduate/GED
Vocational/technical/occupational program
Some college, no degree
Associate degree
Bachelor's degree (example: BA, BS)
Master's degree (example: MA, MS, MEd, MBA, MPH)
Professional school degree (example: MD, DDS, DVM, JD)
Doctoral degree (PhD, EdD, ScD)
Don't know/not sure
Prefer not to answer
Please select your annual household income from all sources:
* must provide value
Less than $25,000
$25,000 to $34,999
$35,000 to $44,999
$45,000 to $54,999
$55,000 to $64,999
$65,000 to $74,999
$75,000 to $99,999
More than $100,000
Don't know/not sure
Prefer not to answer
We would like to know about what you do for your occupation. Please select what applies to you:
* must provide value
Working now
Temporarily out of work (laid off, sick leave, maternity leave)
Looking for work or unemployed
Retired
Disabled, permanently or temporarily
Keeping house
Student
Other
Don't know/not sure
Prefer not to answer
Please describe your occupational title:
* must provide value
Please provide the name of your employer or school:
* must provide value
Please select your current marital status:
* must provide value
Married
Divorced
Widowed
Separated
Never married
A member of an unmarried couple
Don't know/not sure
Prefer not to answer
Please select the response that best describes your living situation:
* must provide value
Alone
With family member(s)
With non-family member(s)
Prefer not to answer
Next, we would like to ask you some questions to determine if you are a good fit for our study. Please answer honestly and to the best of your ability. You do not have to answer any question that you would not like to answer, but without answers to these questions, you will not be eligible to participate in the study. There is no wrong answer.
Have you been previously diagnosed with cancer of any type?
* must provide value
No
Yes
What was your primary cancer diagnosis (type/site: for example, breast, prostate)?
* must provide value
What stage was your cancer, if known?
* must provide value
When was your cancer diagnosed?
* must provide value
Today M-D-Y
What treatment(s) have you received for your cancer? Choose all that apply.
* must provide value
What type of treatment?
* must provide value
Date of surgery or date range of treatment:
* must provide value
Are you currently receiving any therapy or treatment for your cancer?
* must provide value
No
Yes
Please describe:
* must provide value
Do you have an oncologist you currently see for treatment/follow up for your cancer?
* must provide value
No
Yes
Oncologist Name:
* must provide value
Oncologist Location:
* must provide value
Do you have a primary care provider (PCP) 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?
* must provide value
No
Yes
PCP Name:
* must provide value
PCP Location:
* must provide value
Are you willing to establish care with a primary care provider prior to study enrollment?
* must provide value
No
Yes
Select your performance status from the scale below:
* must provide value
0. Fully active, able to carry on all pre-disease performance without restriction
1. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light and sedentary nature (e.g. light house work, office work)
2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
4. Completely disabled, cannot carry on any self-care. Totally confined to bed or chair
Are you a current or former nicotine or tobacco user?
* must provide value
Current
Former
Have never used tobacco
When did you quit?
* must provide value
Today M-D-Y
Have you had any major surgery within the past 3 months, including mastectomy?
* must provide value
No
Yes
What type of surgery?
* must provide value
When?
* must provide value
Today M-D-Y
Do you anticipate needing surgery or any other procedures in the next 8 months?
* must provide value
No
Yes
What type of surgery or procedure?
* must provide value
When?
* must provide value
Today M-D-Y
Have you started cholesterol, blood pressure, or blood sugar medication in past 3 months?
* must provide value
No
Yes
What type of medication?
* must provide value
Are you currently using or have you used oral steroids (i.e., prednisone) in the past 6 months?
* must provide value
No
Yes
Please describe:
* must provide value
Have you completed any treatment that significantly impacts digestion, metabolism, and/or food intake (e.g. surgical loss of esophagus, stomach, colon)?
* must provide value
No
Yes
Please describe:
* must provide value
Are you currently using or have you used prescription or over-the-counter medications that impact your appetite or weight (e.g., appetite suppressants, stimulants, anti-psychotics, tricyclic antidepressants) in the past 6 months?
* must provide value
No
Yes
Please describe:
* must provide value
In the past 6 months, have you had an acute coronary event, unstable angina, coronary revascularization, stroke, or pulmonary embolism?
* must provide value
No
Yes
Please describe:
* must provide value
Do you have symptoms that might suggest a heart problem (e.g., chest pain, shortness of breath at rest or with mild exertion, lightheadedness, passing out)?
* must provide value
No
Yes
Please describe:
* must provide value
Do you have uncontrolled hypertension (high blood pressure), defined as diastolic blood pressure >100 mmHg, systolic blood pressure >160 mmHg, or resting heart rate >100 bpm?
* must provide value
No
Yes
Do you have diabetes (Type 1 or 2)?
* must provide value
No
Yes
Type 1 or Type 2?
* must provide value
Type 1
Type 2
Is your diabetes well-controlled on metformin or a similar medication with A1c <8%?
* must provide value
No
Yes
Do you have a history of uncontrolled thyroid disorder?
* must provide value
No
Yes
Please describe:
* must provide value
Do you have a history of chronic health problems that might impact your ability to safely participate in a diet and exercise program, such as cardiac arrhythmias (irregular heart rhythm) or cardiac valvular disease or significant gastrointestinal (digestive), pulmonary (lung), renal (kidney), musculoskeletal (bone, joint, or muscle), neurologic (brain), hematologic (blood), or psychiatric (mental health) disease?
* must provide value
No
Yes
Please describe:
* must provide value
Do you have current severe depression or history of severe depression within the previous year?
* must provide value
No
Yes
Please describe:
* must provide value
Do you have a history of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which would interfere with ability to adhere to diet and exercise program?
* must provide value
No
Yes
Please describe:
* must provide value
Do you have medical or physical limitations to engaging in physical activity (e.g., paralysis)?
* must provide value
No
Yes
Please describe:
* must provide value
Do you have a history of clinically diagnosed eating disorders including anorexia nervosa, bulimia, or binge eating disorder?
* must provide value
No
Yes
Please describe:
* must provide value
Do you have problems with current or past alcohol or drug abuse?
* must provide value
No
Yes
Please describe:
* must provide value
Are you currently pregnant or lactating?
* must provide value
No
Yes
Were you pregnant within the past 6 months?
* must provide value
No
Yes
Are you currently breastfeeding?
* must provide value
No
Yes
Are you planning to become pregnant in the next 9 months?
* must provide value
No
Yes
Do you (or are you willing to) use a reliable method of birth control for the duration of the study?
* must provide value
No
Yes
Weight and Exercise History
Have you had previous obesity treatment with surgery or weight loss device?
* must provide value
No
Yes
What type?
* must provide value
When?
* must provide value
Today M-D-Y
Have you used prescription weight loss medications or over the counter weight loss supplements in the past 6 months?
* must provide value
No
Yes
What medication(s)?
* must provide value
When did you start taking it/them?
* must provide value
Today M-D-Y
Are you still currently taking it/them?
* must provide value
No
Yes
When did you stop taking it/them?
* must provide value
Today M-D-Y
Have you participated in any formal nutrition, weight loss, or physical activity programs or research studies in the past 6 months? Examples include but are not limited to: BfedBwell, BfitBwell, Time2Bwell, Colorado Weigh, State of Slim, My New Weigh, the BEEF Wise Study, The Beverage Study, the Exercise Timing Study, DRIFT - the intermittent fasting vs. daily caloric restriction study, WeightLoss4Life, Noom®, WW® (formally known as Weight Watchers), PreventT2 (formerly known as Diabetes Prevention Program), Taking Off Pounds Sensibly (TOPS), Jenny Craig®, MOVE, Time2Eat, the TRF study
* must provide value
No
Yes
Please describe:
* must provide value
Are you currently or planning to participate in any other formal nutrition, weight loss, or physical activity programs or research studies in the next 6 months?
* must provide value
No
Yes
Please describe:
* must provide value
Have you participated in the BfitBwell cancer exercise program?
* must provide value
No
Yes
When did you complete the BfitBwell program?
* must provide value
Today M-D-Y
Do you speak English?
* must provide value
No
Yes
Do you live or work within 30 miles of the CU Anschutz Health and Wellness Center? (12348 E Montview Blvd Aurora, CO 80045)
* must provide value
No
Yes
Are you willing to attend weekly small group nutrition education sessions and some, none, or all of the following: monthly in-person cooking demos, weekly online group support, and/or monthly online 1-on-1 counseling held by a registered dietitian?
* must provide value
No
Yes
Group classes will be held in-person and/or virtually via Zoom on a weekday evening. Classes will be held on the same weekday for the duration of the 6-month intervention. Classes will be held weekly during months 0-3, every other week during month 4, and monthly during months 5-6. Other components may or may not be offered depending on which version of the program you are assigned to.
Are you willing to participate in a supervised exercise program and attend weekly in-person exercise sessions at the CU Anschutz Health and Wellness Center with additional online exercise support?
* must provide value
No
Yes
BfitBwell exercise sessions will be held between 8AM and 4PM at the Anschutz Health and Wellness Center weekly during months 0-3 and monthly during months 4-6.
Are you willing to complete in-person study visits at the CU Anschutz Campus for this study?
* must provide value
No
Yes
The study involves 1 weekday in-person screening visit before beginning the study, and 4 weekday in-person visits at weeks 0, 6, 12, and 24 to assess your body weight, body composition, laboratory values, and diet and exercise behaviors.
Do you have access to a computer or smart phone and Internet and are you willing to join Zoom meetings, complete questionnaires, and access/download the True Coach virtual exercise coaching from your smartphone or computer for this study?
* must provide value
No
Yes
Do you have plans to travel for >2 consecutive weeks within the next 6 months?
* must provide value
No
Yes
Do you have plans to relocate/move out of the Denver area within the next 6 months?
* must provide value
No
Yes
Will you refrain from use of all over the counter or prescription weight loss medications for the duration of the study?
* must provide value
No
Yes
Will you refrain from use of all nutritional supplements aside from those prescribed by a physician for the duration of the study?
* must provide value
No
Yes
Are you willing to abstain from participating in any other nutrition, weight loss, or physical activity programs or research studies during the entire duration of the study? This includes visits with a weight management medical provider and/or visits with a registered dietitian (nutritionist) for the purpose of weight loss.
* must provide value
No
Yes