Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005726
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2000-05-25
Brief Title:
Evaluation of Low Literacy CVD Nutrition Education
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-05
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:
To develop and evaluate a nutrition education program to reduce cardiovascular disease risk in persons with low literacy skills
Detailed Description:
BACKGROUND
The setting for the study was the Minnesota Extension Services Expanded Food and Nutrition Education Program EFNEP which was a US Department of Agriculture-funded program to improve the nutrition knowledge and behavior of low-income individuals who were responsible for food preparation The emphasis of EFNEP was on obtaining adequate and nutritious foods and not on dietary behaviors for the prevention of chronic disease Because a large proportion of this population had no more than an 8th grade education 309 percent nationally EFNEP provided access to individuals with low literacy skills and a need for nutrition education for disease prevention For example a pilot study indicated that 34 of 42 respondents had never had their blood cholesterol level checked
The study was part of an NHLBI initiative on CVD Nutrition Education for Low Literacy Skills The initiative originated within the Prevention and Demonstration Branch of the DECA was approved by the September 1988 National Heart Lung and Blood Advisory Council and released in July 1990
DESIGN NARRATIVE
The study developed education strategies using focus groups of both the Minnesota Extension Services Expanded Food and Nutrition Education Program EFNEP program participants and the EFNEP paraprofessionals who delivered the program The intent of the focus groups was to identify concerns interests barriers and perceived needs for nutrition education for cardiovascular disease prevention This information was used to develop effective education strategies that addressed the needs of the study participants while accomplishing the study goal of effecting dietary change specifically decrease in dietary fat and cholesterol intake for cardiovascular disease risk reduction
The effectiveness of the nutrition education program was evaluated in a randomized trial with pre- and post-intervention measures of dietary fat intake and plasma total and HDL cholesterol as outcome measures The study was conducted in Hennepin Ramsey and Dakota Counties which had a total adult EFNEP enrollment of about 1842 people Because EFNEP enrollment was predominantly female 94 percent this study was limited to adult women age 18 or older All 22 EFNEP paraprofessionals in these counties were randomized to intervention and control group Randomization was at the level of paraprofessional to simplify program delivery and to minimize contamination between intervention and control groups The differential changes in fat intake and plasma cholesterol level between the intervention and control groups were estimated using analysis of covariance adjusting for within paraprofessional correlation and other potential confounders
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
The setting for the study was the Minnesota Extension Services Expanded Food and Nutrition Education Program EFNEP which was a US Department of Agriculture-funded program to improve the nutrition knowledge and behavior of low-income individuals who were responsible for food preparation The emphasis of EFNEP was on obtaining adequate and nutritious foods and not on dietary behaviors for the prevention of chronic disease Because a large proportion of this population had no more than an 8th grade education 309 percent nationally EFNEP provided access to individuals with low literacy skills and a need for nutrition education for disease prevention For example a pilot study indicated that 34 of 42 respondents had never had their blood cholesterol level checked
The study was part of an NHLBI initiative on CVD Nutrition Education for Low Literacy Skills The initiative originated within the Prevention and Demonstration Branch of the DECA was approved by the September 1988 National Heart Lung and Blood Advisory Council and released in July 1990
DESIGN NARRATIVE
The study developed education strategies using focus groups of both the Minnesota Extension Services Expanded Food and Nutrition Education Program EFNEP program participants and the EFNEP paraprofessionals who delivered the program The intent of the focus groups was to identify concerns interests barriers and perceived needs for nutrition education for cardiovascular disease prevention This information was used to develop effective education strategies that addressed the needs of the study participants while accomplishing the study goal of effecting dietary change specifically decrease in dietary fat and cholesterol intake for cardiovascular disease risk reduction
The effectiveness of the nutrition education program was evaluated in a randomized trial with pre- and post-intervention measures of dietary fat intake and plasma total and HDL cholesterol as outcome measures The study was conducted in Hennepin Ramsey and Dakota Counties which had a total adult EFNEP enrollment of about 1842 people Because EFNEP enrollment was predominantly female 94 percent this study was limited to adult women age 18 or older All 22 EFNEP paraprofessionals in these counties were randomized to intervention and control group Randomization was at the level of paraprofessional to simplify program delivery and to minimize contamination between intervention and control groups The differential changes in fat intake and plasma cholesterol level between the intervention and control groups were estimated using analysis of covariance adjusting for within paraprofessional correlation and other potential confounders
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL046781 | NIH | None | httpsreporternihgovquickSearchR01HL046781 |