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Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Physical activity and dietary change

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Weight loss, Physical activity, Dietary change

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

21-70 yrs
Stage 0-IIIa breast cancer
No evidence of recurrent/metastatic disease
Hispanic or African descent (African-American or Caribbean)
BMI > 25kg/m2
Sedentary
Completed surgery, chemotherapy, and radiation therapy ≥ 6 months
Blood pressure < 140/90
HgbA1C < 8
LDL cholesterol < 150
No uncontrolled comorbidities
VO2 max normal EKG changes
Non-smoker

Exclusion Criteria:

Evidence of recurrent or metastatic breast cancer
Uncontrolled co-morbid illness including, but not limited to, type I diabetes mellitus, type II diabetes mellitus, hypertension, symptomatic congestive heart failure, unstable angina pectoris, claudication, cardiac arrhythmia; active pulmonary disease; hypercholesterolemia, neurological condition, ischemic heart disease, cardiac disease, kidney disease, respiration problems, asthma, shortness of breath, physical limitations, abnormal thyroid function, active malignancy, except for squamous or basal cell carcinoma of the skin; receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements
Currently taking Herceptin therapy, or abnormal echo or MUGA post-Herceptin therapy
Active tobacco use
Currently active in an exercise and/or dietary change weight loss program
If a participant develops a breast cancer recurrence or metastasis during the 12-month study period, her participation in the study will be terminated.

Sites / Locations

Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Arm Description

Immediate physical activity and dietary change intervention

Delayed physical activity and dietary change intervention

Outcomes

Primary Outcome Measures

Change in weight

Intervention adherence

Secondary Outcome Measures

Barriers to participation

Predictors of adherence

Changes in anthropometric measures

Changes in fitness

Changes in hormonal biomarkers

Changes in metabolic markers

Changes in psychological and quality of life measures

Full Information

NCT ID

NCT00811824

First Posted

December 18, 2008

Last Updated

February 21, 2013

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT00811824

Brief Title

Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors

Official Title

Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is testing the effects of exercise and dietary change on weight reduction and biological markers associated with breast cancer risk in breast cancer survivors of Hispanic or African descent (n=45). This is a randomized, crossover pilot and feasibility study to test the effects of a 30-minute circuit-based exercise program that combines resistance training with aerobic exercise in conjunction with a low-fat calorie reduced diet. Participants will be randomized to either an immediate 6-months of exercise and dietary change, or a delayed group who will begin their exercise and dietary change program 6-months after the study begins. Participants in the immediate group will be followed for an additional 6-months in order to evaluate adherence to the exercise and dietary change recommendations. Participants in both groups will exercise at a neighborhood Curves® facility at least 5 times per week for six months and will participate in a series of nutrition education classes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Weight loss, Physical activity, Dietary change

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Immediate physical activity and dietary change intervention

Arm Title

Arm Type

Other

Arm Description

Delayed physical activity and dietary change intervention

Intervention Type

Behavioral

Intervention Name(s)

Physical activity and dietary change

Intervention Description

6 months of combined resistance training and aerobic exercise (5 times per week x 30 minutes) plus 6-week nutrition counseling class

Primary Outcome Measure Information:

Title

Change in weight

Time Frame

6 months, 12 months

Title

Intervention adherence

Time Frame

6 months, 12 months

Secondary Outcome Measure Information:

Title

Barriers to participation

Time Frame