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Sponsors and Collaborators: |
Kaiser Permanente Garfield Memorial Foundation |
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Information provided by: | Kaiser Permanente |
ClinicalTrials.gov Identifier: | NCT00306709 |
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 |
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Obesity |
Behavioral: culturally adapted behavior change |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Take HEED (Healthy Eating and Exercise Decisions) |
Estimated Enrollment: | 200 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | March 2007 |
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.
Ages Eligible for Study: | 40 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
Kaiser Pemanente | |
Cleveland, Ohio, United States, 44146 |
Principal Investigator: | Pamala J Murphy, MD | Kaiser Permanente |
Study ID Numbers: | OH-04PMurp-01 |
Study First Received: | March 22, 2006 |
Last Updated: | March 22, 2006 |
ClinicalTrials.gov Identifier: | NCT00306709 History of Changes |
Health Authority: | United States: Institutional Review Board |
obesity behavior change cultural adaptations weight loss |
Body Weight Signs and Symptoms Obesity Weight Loss |
Nutrition Disorders Overweight Overnutrition Healthy |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |