Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-30 @ 2:37 AM
Study NCT ID:
NCT02677857
Status:
TERMINATED
Last Update Posted:
2018-04-05
First Post:
2016-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing a Healthy Lifestyle in Breast Cancer Survivors
Sponsor:
The University of Tennessee, Knoxville
Organization:
Study Overview
Official Title:
Developing a Healthy Lifestyle in Breast Cancer Survivors
Status:
TERMINATED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment efforts were not effective.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: