Evaluation of Low Literacy CVD Nutrition Education
|ClinicalTrials.gov Identifier: NCT00005726|
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : February 29, 2016
|First Submitted Date||May 25, 2000|
|First Posted Date||May 26, 2000|
|Last Update Posted Date||February 29, 2016|
|Study Start Date||August 1991|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00005726 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Evaluation of Low Literacy CVD Nutrition Education|
|Official Title||Not Provided|
|Brief Summary||To develop and evaluate a nutrition education program to reduce cardiovascular disease risk in persons with low literacy skills.|
The setting for the study was the Minnesota Extension Service's Expanded Food and Nutrition Education Program (EFNEP), which was a U.S. 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 (30.9 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.
The study developed education strategies using focus groups of both the Minnesota Extension Service's 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 1,842 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 Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Enrollment||Not Provided|
|Actual Study Completion Date||May 1995|
|Primary Completion Date||Not Provided|
|Eligibility Criteria||No eligibility criteria|
|Ages||up to 100 Years (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Not Provided|
|Removed Location Countries|
|Other Study ID Numbers||4935
R01HL046781 ( U.S. NIH Grant/Contract )
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Heart, Lung, and Blood Institute (NHLBI)|
|PRS Account||National Heart, Lung, and Blood Institute (NHLBI)|
|Verification Date||May 2000|