Take HEED (Healthy Eating and Exercise Decisions)

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: culturally adapted behavior change

• Registration Number: NCT00306709
• Lead Sponsor: Kaiser Permanente

Brief 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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2006-03-22
• Study First Submitted QC: 2006-03-22
• Study First Posted: 2006-03-24
• Primary Completion: 2007-06
• Study Completion: 2010-06
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-17
• Last Update Posted: 2010-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 223

Inclusion Criteria

• BMI greater than 30
• African American
• 40-46 years old

Exclusion Criteria

• bariatric surgery within the previous 5 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Teaching	culturally adapted behavior change	-

Primary Outcome Measures

Name	Time	Method
Examine the effect of culturally adapted weight loss program in African American (AA) females age 40-65

Trial Locations

Locations (1)

Kaiser Pemanente; 🇺🇸 Cleveland, Ohio, United States