Breast Cancer
Conditions
Keywords
Overweight, Obese
Brief summary
This is a 3 month single arm pilot and feasibility study designed to examine the impact of an intermittent fasting lifestyle weight loss intervention on pre-specified clinical milestones (change in body weight, adherence to the fasting program, and moderate-to vigorous physical activity, MVPA) in adults with overweight and obesity and breast cancer after they have completed their cancer treatment. The investigators will also evaluate feasibility of recruitment and retention of study participants, safety of the intervention, and obtain feedback from participants to improve the program. Participants will receive a 3 month lifestyle weight loss program focusing on a 4:3 intermittent fasting paradigm (3 modified fast days per week) and support to increase physical activity to 150 minutes per week. Outcome measures will be assessed at the end of the 3 month intervention (primary endpoint) and after a 3 month weight maintenance follow up phase.
Interventions
BEHAVIORALWeight Loss
Participants are instructed to perform a modified fast (\~500 kcal) on 3 days/week with ad libitum intake the other 4 days/week. Group-based behavioral support sessions will be held by an experienced Registered Dietician. Participants will attend BfitBwell exercise sessions in person and virtually to receive individualized support to progress to 150 min/wk of moderate-intensity physical activity
Sponsors
University of Colorado, Denver
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Age 18-65 years * Body Mass Index 25-45 kg/m2 * Diagnosis of stage 1-3 breast cancer within the past 10 years with completion of standard of care definitive surgery, adjuvant chemotherapy, radiation, immunotherapy and/or targeted therapy as appropriate prior to the intervention start date. Completion of definitive surgery must be ≥ 3 months prior to the intervention start date, other therapies must be completed ≥ 1 month prior to the intervention start date (however exceptions to this 1-month 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 treatment prior to the intervention start date). Current/ongoing use of anti-endocrine directed therapy for breast cancer (including ovarian suppression, tamoxifen, aromatase inhibitors, selective estrogen degraders) is acceptable as long as participants have been on therapy for ≥3 months prior to the intervention start date. * 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). * Capable and willing to give informed consent and understand
Exclusion criteria
, willing to attend weekly small group sessions held by a registered dietitian, and attend one in person BfitBwell exercise sessions per week. * Have a primary care provider (PCP) (or are willing to establish care with a PCP prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions. * Obtain a signed medical clearance from their medical provider for participation in the 4:3 IMF dietary intervention and BfitBwell clinical exercise oncology program. * Own or willing to purchase a smart phone or computer to join Zoom meetings, complete questionnaires, and access/download the True Coach virtual exercise coaching sessions. All interested individuals will complete a brief online eligibility screener through REDCap to confirm initial eligibility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | 3 months | Measured using digital scale accurate to =/-0.1 kg, in the morning in a fasted state |
| Adherence to 4:3 Intermittent Fasting Dietary Paradigm as Measured by Food Records | 3 months | Dietary energy intake assessed using written food records for 7 consecutive days |
| Physical Activity | 3 months | Moderate to Vigorous Physical Activity (MVPA) (min/wk) measured with the activPALv4 activity monitor for 7 consecutive days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Enrollment | at recruitment | Number of participants enrolled per month during the recruitment phase. |
| Percent of Participants Completing Outcome Measures | 3 months | Retention of participants in the 3-month intervention assessed by percent of enrolled participants that complete outcome measures. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVictoria Catenacci, MD
University of Colorado, Denver
Outcome results
None listed