- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00306709
Take HEED (Healthy Eating and Exercise Decisions)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
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Cleveland, Ohio, United States, 44146
- Kaiser Pemanente
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI greater than 30
- African American
- 40-46 years old
Exclusion Criteria:
- bariatric surgery within the previous 5 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Teaching
|
Behavior change strategies which have been modified to include spirituality, AA cultural materials and examples woven into the lesson plans, and sustained peer support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Examine the effect of culturally adapted weight loss program in African American (AA) females age 40-65
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pamala J Murphy, MD, Kaiser Permanente
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OH-04PMurp-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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