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CompletedNCT00306709Updated Sep 21, 2010

Take HEED (Healthy Eating and Exercise Decisions)

An interventional study of culturally adapted behavior change in Obesity, sponsored by Kaiser Permanente. Completed at 1 site in United States. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-09-21.

Sponsored by Kaiser Permanente · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
223
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity

Keywords

  • obesity
  • behavior change
  • cultural adaptations
  • weight loss
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 223 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Kaiser Permanente is the lead sponsor of 392 studies on the registry; 42 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

- bariatric surgery within the previous 5 years

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
223 participants (actual)

Study arms

  • Experimental
    Teaching

    Behavioral: culturally adapted behavior change

Interventions

  • Behavioralculturally 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.

06

What researchers measure

Primary outcomes

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

07

Study locations

1 site
  • Kaiser Pemanente
    Cleveland, Ohio 44146, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00306709
Lead sponsor
Kaiser Permanente
First posted
Mar 24, 2006
Start date
Feb 2005
Primary completion
Jun 2007
Completion
Jun 2010
Last update
Sep 21, 2010

Study contacts

Pamala J Murphy, MD
principal investigator · Kaiser Permanente

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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