Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005725
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Low Literacy CVD Diet Education for Blacks
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 demonstrate the efficacy of a set of original cardiovascular CVD nutrition education materials designed to reduce intake of sodium Na fat and cholesterol and which would be appropriate for urban Black adults with 5th to 8th grade reading levels
Detailed Description:
BACKGROUND
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
Materials were designed to accomplish the objectives of conventional nutrition educationbehavior change programs but avoiding the usual dependency of traditional programs on strategies that required a high level of reading and arithmetic Guiding principles were the need to identify the food related conceptual cultural and social frameworks of members of the target audience and develop a program that built upon already-developed alternative communication and coping skills The core of the system was a a protocol for office-based patient assessment and follow up b an educationalmotivational videotape viewed in the clinical setting c scripts and supporting materials for a 4-week minicourse led by a clinic staff member or volunteer and d a package of audiocassettes and supporting printed materials to facilitate self-directed learning over an extended time period Printed materials emphasized the use of cards hence the acronym CARDES that delivered single concepts about nutrition or behavior change and that permitted manipulation selection and reorganization of information
CARDES was developed and evaluated in cooperation with Howard University Hospital in Washington DC Using a randomized two-group design and a 12-24 month follow up serum cholesterol and blood pressure levels of persons counseled with the CARDES program were compared with values for a control group receiving usual care Process measures described adherence outcomes and determinants Secondary outcomes related to CVD risk factor status were also evaluated Prior to the evaluation a pilot study determined the best sequence for delivering the information related to dietary change ie Na first fatcholesterol first or concurrent Subsequent to the evaluation and prior to development of the final system and dissemination plan an assessment was made of the potential utility of CARDES with other black populations with low literacy skills
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 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
Materials were designed to accomplish the objectives of conventional nutrition educationbehavior change programs but avoiding the usual dependency of traditional programs on strategies that required a high level of reading and arithmetic Guiding principles were the need to identify the food related conceptual cultural and social frameworks of members of the target audience and develop a program that built upon already-developed alternative communication and coping skills The core of the system was a a protocol for office-based patient assessment and follow up b an educationalmotivational videotape viewed in the clinical setting c scripts and supporting materials for a 4-week minicourse led by a clinic staff member or volunteer and d a package of audiocassettes and supporting printed materials to facilitate self-directed learning over an extended time period Printed materials emphasized the use of cards hence the acronym CARDES that delivered single concepts about nutrition or behavior change and that permitted manipulation selection and reorganization of information
CARDES was developed and evaluated in cooperation with Howard University Hospital in Washington DC Using a randomized two-group design and a 12-24 month follow up serum cholesterol and blood pressure levels of persons counseled with the CARDES program were compared with values for a control group receiving usual care Process measures described adherence outcomes and determinants Secondary outcomes related to CVD risk factor status were also evaluated Prior to the evaluation a pilot study determined the best sequence for delivering the information related to dietary change ie Na first fatcholesterol first or concurrent Subsequent to the evaluation and prior to development of the final system and dissemination plan an assessment was made of the potential utility of CARDES with other black populations with low literacy skills
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 |
|---|---|---|---|
| R01HL046778 | NIH | None | httpsreporternihgovquickSearchR01HL046778 |