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Baton Rouge, Louisiana 70808


Purpose:

To test the effectiveness and feasibility of intensive motivational, behavior modifying intervention aimed at improving physical activity and dietary habits to produce at least 7% weight loss in women with a history of breast cancer in a community health setting.


Study summary:

This study will be divided into two phases (Phase I and II) that will differ by the intensity of motivational intervention. In Phase I, participants will receive 6 months of intensive weekly group-based or telephone-based motivational, behavior modifying intervention aimed at improving physical activity levels and dietary habits. Phase II will be an additional 6 months of monthly individualized motivational intervention in order to attain and maintain at least 7% body weight loss. All participants will attend an orientation, 2 run-in sessions, and a baseline assessment prior to the intervention. Participants will then be assigned to either the group based intervention or telephone intervention. The first 30 participants will enter into the group-based intervention and the second 30 will enter into the telephone-based intervention. Follow-up visits will be completed at the end of Phase I (week 25) and Phase II (week 50). Up to 60 women with a previous history of breast cancer will participate in this study.


Criteria:

Inclusion Criteria: - Women between the ages of 30 and 75. - Positive history of breast cancer treatment completed at least 2 months but no longer than 36 months prior to randomization. - BMI ≥ 25 kg/m2 and ≤ 45 kg/m2 - Not involved in regular physical activity or weight loss management programs. - Stage I, II or IIIa breast cancer with good prognosis. Exclusion Criteria: - Presence of any co-morbidities including cardiovascular disease or diabetes - Fasting triglycerides > 500 mg/dl. - Consume more than 14 alcoholic beverages per week. - A history of drug abuse, or excess alcohol consumption (40g/day)6. - Currently dieting or engaging in any activity with the goal of losing weight. - Significant intentional weight loss in the past year (> 50 lbs in the past year) or current use of weight loss medications. - History of gastrointestinal bypass or other bariatric surgery in the last 3 years. - Pregnant or plan on becoming pregnant in the next 12 months. - Factors that may limit adherence to intervention or affect conduct of the trial. - Unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment. - Failure to complete run-in and baseline testing. - Lack support from health care provider or family members. - Other temporary intervening event, such as sick spouse, bereavement, or recent move. - Any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise. - Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder. - Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study.


NCT ID:

NCT01217216


Primary Contact:

Principal Investigator
Timothy S Church, MD, MPH, PhD
Pennington Biomedica Research Center


Backup Contact:

N/A


Location Contact:

Baton Rouge, Louisiana 70808
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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