Evaluating the Effectiveness of an Individualized Nutrition and Physical Activity Counseling Program
Keywords
Abstract
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 04/22/2020 |
| Estimated Enrollment Submitted: | 04/23/2020 |
| First Posted: | 04/27/2020 |
| Last Update Submitted: | 07/01/2020 |
| Last Update Posted: | 07/06/2020 |
| Actual Study Start Date: | 07/14/2020 |
| Estimated Primary Completion Date: | 01/31/2021 |
| Estimated Study Completion Date: | 01/31/2021 |
Condition or disease
Intervention/treatment
Behavioral: Individualized, nutrition and physical activity intervention
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Individualized, nutrition and physical activity intervention Initial in-person consult with a registered dietitian, with further in-person follow-ups and monthly telephone consults | Behavioral: Individualized, nutrition and physical activity intervention 6-month interventional, counseling program based on nutrition and physical activity consisting of:
1. Nutritional counseling by a Registered Dietitian (RD) 2) Implementation of an adequate physical activity program |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - 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] Exclusion Criteria: - 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. |
Outcome
Primary Outcome Measures
1. Percent of participants achieving 10% weight loss [At baseline]
2. Percent of participants achieving 10% weight loss [At 3 months]
3. Percent of participants achieving 10% weight loss [At 6 months]
4. Compliance to the recommended dietary pattern [At 3 months]
5. Compliance to physical activity goal [At 6 months]
Secondary Outcome Measures
1. Body fat percentage [Baseline]
2. Body fat percentage [3 months]
3. Body fat percentage [6 months]
4. Glycemic control as measured by HbA1c [At 3 months]
5. Glycemic control as measured by HbA1c [At 6 months]
6. Cholesterol [At 3 months]
7. Cholesterol [At 6 months]
8. Low density lipoprotein [At 3 months]
9. Low density lipoprotein [At 6 months]
10. high density lipoprotein [At 3 months]
11. high density lipoprotein [At 6 months]
12. Triglycerides [At 3 months]
13. Triglycerides [At 6 months]
14. Serum vitamin D [At 3 months]
15. Serum vitamin D [At 6 months]
16. Serum C-reactive protein (CRP) [At 3 months]
17. Serum C-reactive protein (CRP) [At 6 months]
18. Maximum oxygen uptake as measured by VO2 max [Baseline]
19. Maximum oxygen uptake as measured by VO2 max [At 3 months]
20. Maximum oxygen uptake as measured by VO2 max [At 6 months]
Other Outcome Measures
1. Quality of life as measured by Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) [Baseline, 3 months and 6 months]
2. Quality of life as measured by Brief Pain Inventory (BPI) [Baseline, 3 months and 6 months]
3. Quality of life as measured by Generalized Anxiety Disorder-7 (GAD-7) [Baseline, 3 months and 6 months]
4. Quality of life as measured by Patient Health Questionnaire-9 (PHQ-9) [Baseline, 3 months and 6 months]
5. Quality of life as measured by NCCN Distress Thermometer [Baseline, 3 months and 6 months]
6. Factors associated with adherence to the program [At 6 months]
