Developing a Healthy Lifestyle in Breast Cancer Survivors

Stopped early · Not applicable

Conditions studied: Breast Cancer, Sedentary Lifestyle

In brief

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.

Key facts

Study ID: NCT02677857
Run by: The University of Tennessee, Knoxville
People needed: 7
Starts: 2016-01-01
Expected to finish: 2016-12-01
Last updated by the study team: 2018-04-05

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

age between 18 and 65 yrs
BMI between 25 and 45 kg/m2
history of breast cancer (stages I [> 1 cm], II, or III) diagnosed within the previous 5 years
completion of initial therapies
engage in > 8 hours a day of SB
engage in < 100 min/wk MVPA.

You may not qualify if…

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)
report being unable to walk for 2 blocks (1/4 mile) without stopping
report major psychiatric diseases or organic brain syndromes
report a serious medical condition in which weight loss is contraindicated
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
have had bariatric surgery or are planning to have bariatric surgery in the next 6 months
are participating in a program to increase physical activity and/or decrease sedentary time
intend to move outside of the metropolitan area within the time frame of the investigation
are pregnant, lactating, < 6 months post-partum, or plan to become pregnant during the investigation
are unwilling to attend sessions and/or unwilling to be randomized to any treatment condition;
do not own a smartphone that will run the app required for the Polar® Loop device;
are unwilling to use MyFitnessPal or the Polar® Loop device app for smartphones; or
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).

Where it is running

Healthy Eating and Activity Laboratory — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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