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Take HEED (Healthy Eating and Exercise Decisions)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00306709
First Posted: March 24, 2006
Last Update Posted: September 21, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kaiser Permanente
  Purpose
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.

Condition Intervention
Obesity Behavioral: culturally adapted behavior change

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Take HEED (Healthy Eating and Exercise Decisions)

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

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

Enrollment: 223
Study Start Date: February 2005
Study Completion Date: June 2010
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teaching Behavioral: culturally adapted behavior change
Behavior change strategies which have been modified to include spirituality, AA cultural materials and examples woven into the lesson plans, and sustained peer support.

Detailed Description:

Project/study objective(s), 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.

Methods, The 21 month program (6 months active intervention and 15 months maintenance) is provided by a Nurse matched with the study participants for race, age, and gender. Take HEED uses behavior change strategies (Prochaska et al 1992) which have been modified to include spirituality, AA cultural materials and examples woven into the lesson plans, and sustained peer support. The diet has been modified to include calorie reductions, increased fruit/ vegetable and calcium intake, incorporation of AA ethnic recipes. Exercise has been culturally adapted featuring line- dancing, brisk walking and includes socialization time for development of strong interpersonal bonds that will encourage exercise in the participants. The control group receives KP's usual care which is a combination of nutrition classes and web based learning.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI greater than 30
  • African American
  • 40-46 years old

Exclusion Criteria:

- bariatric surgery within the previous 5 years

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306709


Locations
United States, Ohio
Kaiser Pemanente
Cleveland, Ohio, United States, 44146
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Pamala J Murphy, MD Kaiser Permanente
  More Information

Responsible Party: Pamala Murphy, MD, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00306709     History of Changes
Other Study ID Numbers: OH-04PMurp-01
First Submitted: March 22, 2006
First Posted: March 24, 2006
Last Update Posted: September 21, 2010
Last Verified: September 2010

Keywords provided by Kaiser Permanente:
obesity
behavior change
cultural adaptations
weight loss