Weight Loss Counseling for African American Women Who Are Breast Cancer Survivors

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00872677
First received: March 28, 2009
Last updated: April 25, 2013
Last verified: April 2013

March 28, 2009
April 25, 2013
May 2004
October 2006   (final data collection date for primary outcome measure)
Weight change [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Weight change [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00872677 on ClinicalTrials.gov Archive Site
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Weight Loss Counseling for African American Women Who Are Breast Cancer Survivors
A Culturally-Tailored Weight Loss Program

RATIONALE: A culturally sensitive weight loss program for obese African American breast cancer survivors may be more effective than a standard weight loss program in helping women lose weight.

PURPOSE: This randomized clinical trial is studying personalized weight loss counseling to see how well it works in African American women who are breast cancer survivors.

OBJECTIVES:

  • To develop a weight loss intervention for obese African American women who are breast cancer survivors.

OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 intervention groups.

  • Group 1: Participants receive traditional individual dietary and exercise counseling in combination with the Weight Watchers weight loss program for 18 months.
  • Group 2: Participants receive individual dietary and exercise counseling in combination with the Weight Watchers weight loss program as in group 1. They also receive spiritual counseling that incorporates meditation, readings, and the recording of thoughts into a long-term weight management program. The program addresses coping with stress, setting priorities, dealing with emotional issues that trigger old behavior patterns, and developing accountability for following desired diet and exercise patterns.
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Two groups to participate:

Group 1: Dietitian led counseling and Weight Watchers groups for 18 months Group 2: Dietitian led counseling and Weight Watchers groups for 18 months with Spirituality counseling from 6 to 18 months.

  • Breast Cancer
  • Obesity
  • Weight Changes
  • Behavioral: Diet
    Talk to study dietitian (eight in person or by phone) weekly for the first 3 months, every other week for the next 3 months and monthly thereafter.
  • Other: Spiritual counseling
    Spiritual counselor weekly in months 6-9, every other week in months 9-12 and monthly thereafter.
  • Dietitian-led counseling and Weight Watchers
    Talk to study dietitian (eight in person or by phone) weekly for the first 3 months, every other week for the next 3 months and monthly thereafter.
    Intervention: Behavioral: Diet
  • Dietitian & Weight Watchers + Spirituality Counseling
    Dietitian wkly for the 1st-3 months, every other week for the next 3 months and monthly thereafter; Spiritual counselor weekly in months 6-9, every other week in months 9-12 and monthly thereafter.
    Interventions:
    • Behavioral: Diet
    • Other: Spiritual counseling
Djuric Z, Mirasolo J, Kimbrough L, Brown DR, Heilbrun LK, Canar L, Venkatranamamoorthy R, Simon MS. A pilot trial of spirituality counseling for weight loss maintenance in African American breast cancer survivors. J Natl Med Assoc. 2009 Jun;101(6):552-64.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
November 2008
October 2006   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer within the past 5 years

    • Stage I-IIIA disease
    • No recurrence of cancer
  • Identified as African American
  • Body Mass Index 30-40
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • Stable body weight
  • Not currently following a special diet
  • No uncontrolled congestive heart failure, untreated hypertension, disabling osteoarthritis, drug or alcohol abuse, or psychiatric conditions that may interfere with counseling

PRIOR CONCURRENT THERAPY:

  • More than 3 months since prior chemotherapy or radiotherapy
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00872677
CDR0000612147, 013003B3E
No
Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
  • National Center for Complementary and Alternative Medicine (NCCAM)
  • National Cancer Institute (NCI)
Principal Investigator: Michael S. Simon, MD, MPH Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
April 2013

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