NCT00306709

Brief Summary

This is a randomized intervention that examines the effect of culturally adapted weight loss program in African American (AA) females age 40-65. Evidence suggests that AA women are more successful with weight loss programs that are culturally tailored (Karanja, et al, 2002). Take HEED is a combination of 2 interventions, Therapeutic Lifestyle Changes Diet (TLC) from ATP-III and the CHANGE exercise program, which have shown success independently in previous clinical trials with AAs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

Enrollment Period

2.3 years

First QC Date

March 22, 2006

Last Update Submit

September 17, 2010

Conditions

Obesity

Keywords

obesitybehavior changecultural adaptationsweight loss

Outcome Measures

Primary Outcomes (1)

  • Examine the effect of culturally adapted weight loss program in African American (AA) females age 40-65

Study Arms (1)

Teaching

EXPERIMENTAL
Behavioral: culturally adapted behavior change

Interventions

culturally adapted behavior changeBEHAVIORAL

Behavior change strategies which have been modified to include spirituality, AA cultural materials and examples woven into the lesson plans, and sustained peer support.

Teaching

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI greater than 30
  • African American
  • years old

You may not qualify if:

  • \- bariatric surgery within the previous 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Pemanente

Cleveland, Ohio, 44146, United States

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Pamala J Murphy, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 22, 2006

First Posted

March 24, 2006

Study Start

February 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2010

Last Updated

September 21, 2010

Record last verified: 2010-09

Locations

US(1)