Clinical trial NCT00872677: Weight Loss Counseling for African American Women Who Are Breast Cancer Survivors
Official title: A Culturally-Tailored Weight Loss Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Obesity
Weight Changes
Keywords: weight changes
obesity
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: National Cancer Institute (NCI)
First posted: 2009-03-31
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Weight change
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Michael S. Simon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/s0027-9684(15)30940-8.