Clinical Trials Directory

Trials / Completed

CompletedNCT00306709

Take HEED (Healthy Eating and Exercise Decisions)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
223 (actual)
Sponsor
Kaiser Permanente · Academic / Other
Sex
Female
Age
40 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALculturally adapted behavior changeBehavior change strategies which have been modified to include spirituality, AA cultural materials and examples woven into the lesson plans, and sustained peer support.

Timeline

Start date
2005-02-01
Primary completion
2007-06-01
Completion
2010-06-01
First posted
2006-03-24
Last updated
2010-09-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00306709. Inclusion in this directory is not an endorsement.