Take HEED (Healthy Eating and Exercise Decisions)
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.
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.
Status: Active, not recruiting (N/A). Started on February 1st, 2005. Ended on March 1st, 2007.
Enrollment: 200 subjects
Study Type: Interventional
Study Design:
- Prevention
- Randomized
- Open Label
- Active Control
- Single Group Assignment
- Efficacy Study
Conditions:
Interventions:
- Behavioral: culturally adapted behavior change
Eligibility
Inclusion Criteria:
BMI greater than 30
African American
40-46 years old
Exclusion Criteria:
- bariatric surgery within the previous 5 years
- Gender
Female
- Mininum Age
40 Years
- Maximum Age
65 Years
- Healthy Volunteers
No
Resources
Source: Kaiser Permanente
Authority: United States: Institutional Review Board
Locations
-
Kaiser Pemanente
Cleveland
Ohio
44146
United States
Officials
Pamala J Murphy, MD (Principal Investigator, Kaiser Permanente)
Sponsors
Kaiser Permanente (Lead Sponsor)
Garfield Memorial Foundation (Collaborator)
References
None.
Links
None.
- Date Verified
- March 1st, 2006
- First Received
- March 22nd, 2006
- Last Changed
- March 22nd, 2006
Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.
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