Take HEED (Healthy Eating and Exercise Decisions)
|ClinicalTrials.gov Identifier: NCT00306709|
Recruitment Status : Completed
First Posted : March 24, 2006
Last Update Posted : September 21, 2010
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: culturally adapted behavior change||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||223 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Take HEED (Healthy Eating and Exercise Decisions)|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2010|
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.
- Examine the effect of culturally adapted weight loss program in African American (AA) females age 40-65
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306709
|United States, Ohio|
|Cleveland, Ohio, United States, 44146|
|Principal Investigator:||Pamala J Murphy, MD||Kaiser Permanente|