Clinical trial NCT02677857: Developing a Healthy Lifestyle in Breast Cancer Survivors
Official title: Developing a Healthy Lifestyle in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Sedentary Lifestyle
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At this time, no study has examined the effect of a lifestyle intervention with a reduced Sedentary Behavior (SB) prescription on overall physical activity, weight loss, metabolic dysfunction, and inflammation in breast cancer survivors. Thus, in collaboration with University of Tennessee Medical Center's (UTMC) Cancer Institute, investigators propose to randomize 30 female breast cancer survivors (history of breast cancer stages I \[\> 1 cm\], II, or III) with a body mass index (BMI) between 25 and 45 kg/m2 who are sedentary (engage in \> 8 hours a day of SB) and inactive (engage in \< 100 min/wk MVPA) to one of three, 3-month conditions:

1. lifestyle intervention (Lifestyle) (increase MVPA to \> 200 min/wk);
2. lifestyle intervention with a reduced SB prescription (Lifestyle+SB) (increase MVPA to \> 200 min/wk and reduce SB by 2 hrs/day); or
3. weight management education materials provided via mailed newsletter (Newsletter).

Lifestyle and Lifestyle+SB will receive a standard dietary (low-calorie \[1200-1500 kcal/day\], low-fat \[\<30% calories from fat\]) prescription that emphasizes intake of fruits, vegetables, and whole grains, and a cognitive behavioral intervention to assist with meeting activity and diet goals. Dependent variables, measured at 0 and 3 months, include objectively measured SB, LPA, MVPA, and total activity via accelerometry; self-reported SB; percent weight loss; insulin and glucose, and leptin and C-reactive protein (CRP) (biomarkers of cancer prognosis that have been found to be positively related to SB and/or adiposity); diet; body composition; and fitness.


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).

Primary outcomes:
measure: Measures of activity by Armband
timeFrame: change from baseline to 12 weeks
measure: Weight
timeFrame: change from baseline to 12 weeks
measure: Measures of diet
timeFrame: change from baseline to 12 weeks
measure: Fitness (The 6 Minute Walk Test (6MWT))
timeFrame: change from baseline to 12 weeks
measure: Physical activity by Questionnaire
timeFrame: change from baseline to 12 weeks
measure: Insulin
timeFrame: change from baseline to 12 weeks
measure: Glucose
timeFrame: change from baseline to 12 weeks
measure: Leptin
timeFrame: change from baseline to 12 weeks
measure: C-Reactive Protein
timeFrame: change from baseline to 12 weeks
measure: Height
timeFrame: baseline
measure: BMI
timeFrame: change from baseline to 12 weeks
measure: Waist circumference
timeFrame: change from baseline to 12 weeks
measure: Percent body fat
timeFrame: change from baseline to 12 weeks
Secondary outcomes:
measure: Completion of self-monitoring records
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: Healthy Eating and Activity Laboratory
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Hollie Raynor
role: PRINCIPAL_INVESTIGATOR
References: