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

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ClinicalTrials.gov Identifier: NCT00872677
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : April 29, 2013
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Brief Summary:

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 or disease Intervention/treatment
Breast Cancer Obesity Weight Changes Behavioral: Diet Other: Spiritual counseling

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.

Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Culturally-Tailored Weight Loss Program
Study Start Date : May 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Weight change [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Integrative Health (NCCIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Michael S. Simon, MD, MPH Barbara Ann Karmanos Cancer Institute

Publications of Results:
Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00872677     History of Changes
Obsolete Identifiers: NCT00082056
Other Study ID Numbers: CDR0000612147
013003B3E ( Other Identifier: Wayne State University - Human Investigation Committee )
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: April 29, 2013
Last Verified: April 2013

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:
Breast Neoplasms
Body Weight
Weight Loss
Body Weight Changes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms