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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heather Greenlee, Columbia University
ClinicalTrials.gov Identifier:
NCT00811824
First received: December 18, 2008
Last updated: February 21, 2013
Last verified: February 2013

December 18, 2008
February 21, 2013
July 2007
September 2009   (final data collection date for primary outcome measure)
  • Change in weight [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Intervention adherence [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00811824 on ClinicalTrials.gov Archive Site
  • Barriers to participation [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Predictors of adherence [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Changes in anthropometric measures [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Changes in fitness [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Changes in hormonal biomarkers [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Changes in metabolic markers [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Changes in psychological and quality of life measures [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors
Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Breast Cancer
Behavioral: Physical activity and dietary change
6 months of combined resistance training and aerobic exercise (5 times per week x 30 minutes) plus 6-week nutrition counseling class
  • Active Comparator: 1
    Immediate physical activity and dietary change intervention
    Intervention: Behavioral: Physical activity and dietary change
  • 2
    Delayed physical activity and dietary change intervention
    Intervention: Behavioral: Physical activity and dietary change
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
November 2012
September 2009   (final data collection date for primary outcome measure)

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.
Female
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00811824
AAAB8839
No
Heather Greenlee, Columbia University
Columbia University
Not Provided
Principal Investigator: Heather Greenlee, ND, PhD Columbia University
Columbia University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP