Take HEED (Healthy Eating and Exercise Decisions)
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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 Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Take HEED (Healthy Eating and Exercise Decisions) |
- 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| Ages Eligible for Study: | 40 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- BMI greater than 30
- African American
- 40-46 years old
Exclusion Criteria:
- bariatric surgery within the previous 5 years
Contacts and Locations More Information
No publications provided
| Responsible Party: | Pamala Murphy, MD, Kaiser Permanente |
| ClinicalTrials.gov Identifier: | NCT00306709 History of Changes |
| Other Study ID Numbers: | OH-04PMurp-01 |
| Study First Received: | March 22, 2006 |
| Last Updated: | September 17, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Kaiser Permanente:
|
obesity behavior change cultural adaptations weight loss |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013