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

Tracking Information

First Received Date ^ICMJE

March 28, 2009

Last Updated Date

May 9, 2009

Start Date ^ICMJE

May 2004

Estimated Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Weight change [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00872677 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Culturally-Tailored Weight Loss Program

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.

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Open Label, Active Control

Condition ^ICMJE

Breast Cancer
Obesity
Weight Changes

Intervention ^ICMJE

Behavioral: behavioral dietary intervention
Behavioral: exercise intervention
Other: counseling intervention
Other: educational intervention
Procedure: meditation therapy
Procedure: spiritual therapy
Procedure: stress management therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00872677

Responsible Party

Study ID Numbers ^ICMJE

CDR0000612147, NCCAM-013003B3E

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Michael S. Simon, MD, MPH

Barbara Ann Karmanos Cancer Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

March 2009

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