Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306709
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2006-03-22
Brief Title:
Take HEED Healthy Eating and Exercise Decisions
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Take HEED Healthy Eating and Exercise Decisions
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
Projectstudy objectives 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 KPs usual care which is a combination of nutrition classes and web based learning
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 KPs usual care which is a combination of nutrition classes and web based learning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None