Status:
COMPLETED
Cancer Survival Through Weight Loss and Exercise
Lead Sponsor:
Pennington Biomedical Research Center
Conditions:
Breast Cancer Survivors
Eligibility:
FEMALE
30-75 years
Phase:
NA
Brief Summary
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...
Detailed Description
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-bas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01217216
Start Date
May 1 2009
End Date
October 1 2010
Last Update
September 15 2022
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808