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

Sponsor

Barbara Ann Karmanos Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00872677

Collaborator

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

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

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 1, 2004

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Weight change [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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