Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT02677857
Eligibility Criteria:
Inclusion Criteria:
1. age between 18 and 65 yrs
2. BMI between 25 and 45 kg/m2
3. history of breast cancer (stages I \[\> 1 cm\], II, or III) diagnosed within the previous 5 years
4. completion of initial therapies
5. engage in \> 8 hours a day of SB
6. engage in \< 100 min/wk MVPA.
Exclusion Criteria:
1. report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q)25 (The Health Screening Questionnaire will also be used to identify individuals with joint problems, prescription medication usage, or other medical conditions that could limit exercise, and these individuals will be required to obtain written physician consent to participate - the two questionnaires are found in questions 4-11 in the phone screen in Appendix B)
2. report being unable to walk for 2 blocks (1/4 mile) without stopping
3. report major psychiatric diseases or organic brain syndromes
4. report a serious medical condition in which weight loss is contraindicated
5. are currently participating in a weight loss program and/or taking weight loss medication or lost \> 5% of body weight during the past 6 months
6. have had bariatric surgery or are planning to have bariatric surgery in the next 6 months
7. are participating in a program to increase physical activity and/or decrease sedentary time
8. intend to move outside of the metropolitan area within the time frame of the investigation
9. are pregnant, lactating, \< 6 months post-partum, or plan to become pregnant during the investigation
10. are unwilling to attend sessions and/or unwilling to be randomized to any treatment condition;
11. do not own a smartphone that will run the app required for the Polar® Loop device;
12. are unwilling to use MyFitnessPal or the Polar® Loop device app for smartphones; or
13. have a metal allergy or are not able to wear anything on an upper arm (which would prevent the ability of participant to wear the SenseWear® armband from BodyMedia® used in the proposed study).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02677857
Study Brief:
Protocol Section:
NCT02677857