Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Nutrition and physical activity counseling program
- Registration Number
- NCT04365569
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
More than 65% of breast cancer survivors are overweight and less than one-third participate in recommended levels of physical exercise. Obese breast cancer survivors have been found to have greater than a two-fold increase in mortality compared to women with normal body mass index (BMI). The current standard for weight loss interventions involves in-person counseling. However, this incurs costs related to travel for counseling sessions, potentially limiting program participation, compliance and sustainability.This is a pilot study of an individualized in-person and telephone-based nutrition and exercise counseling program.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- Breast cancer diagnosis (stage 0-III)
- Body mass index of 25mg/k2 or greater
- Actively being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center
- Able and willing to participate in nutrition counseling at Maroone Cancer Center
- Able (cleared by participant's primary oncologist) and willing to perform cardiopulmonary exercise testing
- Participants must have the ability to understand and the willingness to sign a written informed consent document
- Performance status 0 or 1 as per ECOG scale [see Appendix IV]
- Body mass index below 25kg/m2
- No prior history of breast cancer
- History of metastatic disease
- Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center
- Unable or unwilling to participate in nutrition counseling at Maroone Cancer Center
- Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Participants actively undergoing chemotherapy, immunotherapy or radiation treatment. However, participants currently taking hormonal therapy, such as selective estrogen receptor modulators (SERMS), or aromatase inhibitors, may be included in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Individualized, nutrition and physical activity intervention Nutrition and physical activity counseling program Initial in-person consult with a registered dietitian, with further in-person follow-ups and monthly telephone consults
- Primary Outcome Measures
Name Time Method Percent of participants achieving 10% weight loss At 6 months Efficacy of intervention as assessed by percent of participants achieving 10% weight loss
Compliance to physical activity goal At 6 months Percent of participants complying with proposed activity goal of 150 minutes of moderate intensity physical activity or 75 minutes of vigerous intensity physical activity (or a combination of both) per week over six months
Compliance to the recommended dietary pattern At 3 months Assess compliance to the recommended dietary pattern, diet quality scores will be calculated by the RD after monthly telephone consults or in-person at 3 months and 6 months into the intervention. Each of the 3 elements will be scored from 0-3, resulting in a total score range from 0-9
- Secondary Outcome Measures
Name Time Method Maximum oxygen uptake as measured by VO2 max At 6 months Maximum oxygen uptake as measured by VO2 max
Glycemic control as measured by HbA1c At 6 months Glycemic control as measured by HbA1c
high density lipoprotein At 6 months Effect of the intervention on lipid profile as measured by high density lipoprotein levels
Serum C-reactive protein (CRP) At 6 months Effect of the intervention on CRP
Cholesterol At 6 months Effect of the intervention on lipid profile as measured by high density cholesterol levels
Low density lipoprotein At 6 months Effect of the intervention on lipid profile as measured by low density lipoprotein levels
Triglycerides At 6 months Effect of the intervention on lipid profile as measured by triglyceride levels
Serum vitamin D At 6 months Effect of the intervention on serum vitamin D
Body fat percentage 6 months Body fat percentage measured by the registered dietitian (RD) using bioelectrical impedance analysis
Trial Locations
- Locations (1)
Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center
🇺🇸Weston, Florida, United States