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CompletedNCT00811824Updated Feb 22, 2013

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

A Phase 2 interventional study of Physical activity and dietary change in Breast Cancer, sponsored by Columbia University. Completed at 1 site in United States. Open to female participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-02-22.

Sponsored by Columbia University · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Weight loss
  • Physical activity
  • Dietary change
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 42 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.

Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Active comparator
    1

    Immediate physical activity and dietary change intervention

    Behavioral: Physical activity and dietary change

  • Other
    2

    Delayed physical activity and dietary change intervention

    Behavioral: Physical activity and dietary change

Interventions

  • BehavioralPhysical 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

06

What researchers measure

Primary outcomes

  1. Change in weight

    Time frame: 6 months, 12 months

  2. Intervention adherence

    Time frame: 6 months, 12 months

Secondary outcomes

  1. Barriers to participation

    Time frame: 3 months, 6 months, 9 months, 12 months

  2. Predictors of adherence

    Time frame: 3 months, 6 months, 9 months, 12 months

  3. Changes in anthropometric measures

    Time frame: 3 months, 6 months, 9 months, 12 months

  4. Changes in fitness

    Time frame: 3 months, 6 months, 9 months, 12 months

  5. Changes in hormonal biomarkers

    Time frame: 3 months, 6 months, 9 months, 12 months

  6. Changes in metabolic markers

    Time frame: 3 months, 6 months, 9 months, 12 months

  7. Changes in psychological and quality of life measures

    Time frame: 3 months, 6 months, 9 months, 12 months

07

Study locations

1 site
  • Columbia University
    New York, New York 10032, United States
08

References and documents

Publications

  • Delgado-Cruzata L, Zhang W, McDonald JA, Tsai WY, Valdovinos C, Falci L, Wang Q, Crew KD, Santella RM, Hershman DL, Greenlee H. Dietary modifications, weight loss, and changes in metabolic markers affect global DNA methylation in Hispanic, African American, and Afro-Caribbean breast cancer survivors. J Nutr. 2015 Apr;145(4):783-90. doi: 10.3945/jn.114.202853. Epub 2015 Feb 4. PubMed 25833781 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00811824
Lead sponsor
Columbia University
Responsible party
Heather Greenlee (Assistant Professor, Department of Epidemiology, Columbia University) — Principal investigator
First posted
Dec 19, 2008
Start date
Jul 2007
Primary completion
Sep 2009
Completion
Nov 2012
Last update
Feb 22, 2013

Study contacts

Heather Greenlee, ND, PhD
principal investigator · Columbia University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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