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

This study has been completed.
Sponsor:
Collaborators:
National Center for Complementary and Alternative Medicine (NCCAM)
National Cancer Institute (NCI)
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
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
Obesity
Weight Changes
 Behavioral: Diet
Other: Spiritual counseling

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Culturally-Tailored Weight Loss Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Weight change [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: May 2004
Study Completion Date: November 2008
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
 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.
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.
 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.

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872677

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Center for Complementary and Alternative Medicine (NCCAM)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Michael S. Simon, MD, MPH Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00872677     History of Changes
Obsolete Identifiers: NCT00082056
Other Study ID Numbers: CDR0000612147, 013003B3E
Study First Received: March 28, 2009
Last Updated: April 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
weight changes
obesity
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Body Weight Changes
Breast Neoplasms
Obesity
Weight Loss
Body Weight
Signs and Symptoms
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases
Overnutrition
Nutrition Disorders
Overweight

ClinicalTrials.gov processed this record on May 16, 2013