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OpenTrials
Completed

NCT Number: NCT00872677

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Behavioral

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.

Spiritual counseling

Other

Spiritual counselor weekly in months 6-9, every other week in months 9-12 and monthly thereafter.

Primary outcomes

  1. Weight change

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Barbara Ann Karmanos Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

A Culturally-Tailored Weight Loss Program

Important dates

Study start
2004
Primary completion
2006
Study completion
2008
First posted
Mar 31, 2009
Registry last updated
Apr 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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