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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group-based Intervention | Active Comparator | We randomly assigned 30 individuals to a group-based intervention to promote weight loss through dietary restriction and physical activity. |
|
| Telephone-based Intervention | Active Comparator | We randomly assigned 22 individuals to the telephone-based intervention to promote weight loss through dietary restriction and physical activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group-based Intervention | Behavioral | compared effects of a group-based intervention on weight loss and physical activity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | To examine the effectiveness of using motivational, behavioral interventions aimed at improving physical activity levels and dietary habits to produce weight loss in women with a history of breast cancer. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of recruiting breast cancer survivors | To examine the feasibility of recruiting, administering, and maintaining interventions in a small sample of women with a history of breast cancer in a community health setting for pilot data. | 1 year |
| Examination of health outcomes, breast cancer reoccurrence, and mortality. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy S Church, MD, MPH, PhD | Pennington Biomedica Research Center | Principal Investigator |
| Donna H Ryan, MD | Pennington Biomedical Research Center | Study Director |
| Conrad P Earnest, PhD | Pennington Biomedical Research Center | Study Director |
| Valerie H Myers, PhD | Pennington Biomedical Research Center | Study Director |
| Catherine M Champagne, PhD | Pennington Biomedical Research Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22535636 | Result | Harris MN, Swift DL, Myers VH, Earnest CP, Johannsen NM, Champagne CM, Parker BD, Levy E, Cash KC, Church TS. Cancer survival through lifestyle change (CASTLE): a pilot study of weight loss. Int J Behav Med. 2013 Sep;20(3):403-12. doi: 10.1007/s12529-012-9234-5. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Telephone-based Intervention | Behavioral | compared telephone-based intervention to weight loss and physical activity. |
|
To examine health outcomes, cancer reoccurrence, and mortality in women with a history of breast cancer within the 12 month period via adverse events. Additional procedures include resting ECG, waist circumference, weight, and blood work. |
| 1 year |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |