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NCT02677857 · ClinicalTrials.gov registry record · NA
Developing a Healthy Lifestyle in Breast Cancer Survivors
A NA study, sponsored by The University of Tennessee, Knoxville.
- Terminated
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT02677857 is a NA study that was terminated before completion, run by The University of Tennessee, Knoxville. The registered enrollment target is 7 participants.
The verdict
NCT02677857, a NA study, was terminated before completion, sponsored by The University of Tennessee, Knoxville.
- TERMINATED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Common intervention components for Lifestyle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2016-01 |
| Est. Completion | 2016-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02677857
The ClinicalTrials.gov registry entry for NCT02677857 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Tennessee, Knoxville, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Common intervention components for Lifestyle is the first listed.
NCT02677857 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02677857 about?
NCT02677857 is a clinical study titled "Developing a Healthy Lifestyle in Breast Cancer Survivors". 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 Ce...
What is the current status of trial NCT02677857?
This trial is currently terminated. It is a NA study. The enrollment target is 7 participants. The study started on 2016-01. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02677857?
The interventions under investigation include: Common intervention components for Lifestyle (BEHAVIORAL).
Who is sponsoring clinical trial NCT02677857?
This trial is sponsored by The University of Tennessee, Knoxville, which has 81 total clinical trials registered on ClinicalTrials.gov.
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