NCT00872677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
Last Updated

April 29, 2013

Status Verified

April 1, 2013

Enrollment Period

2.4 years

First QC Date

March 28, 2009

Last Update Submit

April 25, 2013

Conditions

Breast CancerObesityWeight Changes

Keywords

weight changesobesitystage I breast cancerstage II breast cancerstage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

  • Weight change

    18 months

Study Arms (2)

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

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: DietOther: Spiritual counseling

Interventions

DietBEHAVIORAL

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 CounselingDietitian-led counseling and Weight Watchers
Spiritual counselingOTHER

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

Dietitian & Weight Watchers + Spirituality Counseling

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Related 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. doi: 10.1016/s0027-9684(15)30940-8.

    PMID: 19585923RESULT

MeSH Terms

Conditions

Breast NeoplasmsObesityBody Weight Changes

Interventions

Diet

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Michael S. Simon, MD, MPH

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2009

First Posted

March 31, 2009

Study Start

May 1, 2004

Primary Completion

October 1, 2006

Study Completion

November 1, 2008

Last Updated

April 29, 2013

Record last verified: 2013-04

Locations

US(1)