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

Breast Cancer Clinical Trial

Official title:

A Culturally-Tailored Weight Loss Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872677
• Other study ID #: CDR0000612147
• Secondary ID: 013003B3E
• Status: Completed
• Phase: N/A
• First received: March 28, 2009
• Last updated: April 25, 2013
• Start date: May 2004
• Est. completion date: November 2008

Study information

• Verified date: April 2013
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00082056

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2008
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Breast Cancer
• Breast Neoplasms
• Obesity
• Weight Changes

Intervention

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.

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change		18 months	No