Cancer Survival Through Weight Loss and Exercise

NCT ID: NCT01217216

Last Updated: 2022-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-10-31

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 with a history of breast cancer in a community health setting.

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-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.

Conditions

Breast Cancer Survivors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group-based Intervention

We randomly assigned 30 individuals to a group-based intervention to promote weight loss through dietary restriction and physical activity.

Group Type: ACTIVE_COMPARATOR

Group-based Intervention

Intervention Type: BEHAVIORAL

compared effects of a group-based intervention on weight loss and physical activity.

Telephone-based Intervention

We randomly assigned 22 individuals to the telephone-based intervention to promote weight loss through dietary restriction and physical activity.

Group Type: ACTIVE_COMPARATOR

Telephone-based Intervention

Intervention Type: BEHAVIORAL

compared telephone-based intervention to weight loss and physical activity.

Interventions

Group-based Intervention

compared effects of a group-based intervention on weight loss and physical activity.

Intervention Type: BEHAVIORAL

Telephone-based Intervention

compared telephone-based intervention to weight loss and physical activity.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy S Church, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedica Research Center

Donna H Ryan, MD

Role: STUDY_DIRECTOR

Pennington Biomedical Research Center

Conrad P Earnest, PhD

Role: STUDY_DIRECTOR

Pennington Biomedical Research Center

Valerie H Myers, PhD

Role: STUDY_DIRECTOR

Pennington Biomedical Research Center

Catherine M Champagne, PhD

Role: STUDY_DIRECTOR

Pennington Biomedical Research Center

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22535636 (View on PubMed)

Other Identifiers

PBRC 28036

Identifier Type: -

Identifier Source: org_study_id