Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005724
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2000-05-25
Brief Title:
CVD Nutrition Modules Tailored to Low Literacy Skills
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
CVD Nutrition Modules Tailored to Low Literacy Skills
Status:
COMPLETED
Status Verified Date:
2017-04
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 cardiovascular disease nutrition modules tailored to subjects with low literacy skills
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
The study had three phases The goal of Phase I was to develop two innovative care modules that used demographic psycho-social nutritional and behavioral information to individually tailor nutrition treatment programs for southern patients with less than ninth grade reading skills Counselor Directed innovative care consisted of a structured assessment and intervention package of simply written graphically-oriented printed materials to guide the patient and health counselor nutritionist health educator nurse or physician Computer Assisted innovative care used a user-friendly interactive computer assisted program permitting more sophisticated tailoring to individual needs conveying nutrition information in a vivid understandable format and extending the services of the health counselor The investigators used focus groups of patients with low literacy skills to aid in concept development and refinement of intervention delivery strategies Reliable and valid assessments of readability and comprehension helped further refine the materials
In Phase II a randomized trial was conducted to determine if the innovative modules produced a meaningful reduction in cholesterol and overall cardiovascular risk compared to standard care Subjects with high cholesterol and low literacy skills served by four community health centers were randomly assigned to one of four groups Innovative Care-Counselor Directed Innovative Care-Computer Assisted Standard Care and Usual Care for dietary treatment of cholesterol obesity and hypertension Standard Care involved the same amount of time and health counselor exposure as Innovative Care but used currently available materials Usual Care patients were referred to their usual provider for treatment After four months and again at one year changes in lipids blood pressure and weight were assessed
Phase Ill consisted of a feasibility study to test the ability of both innovative care modules to reach low literacy adults through county health departments worksites and churches Results of the feasibility assessment helped refine a dissemination strategy using the state health department as a centralized coordinating agency and county health departments to implement the interventions at the community level
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 had three phases The goal of Phase I was to develop two innovative care modules that used demographic psycho-social nutritional and behavioral information to individually tailor nutrition treatment programs for southern patients with less than ninth grade reading skills Counselor Directed innovative care consisted of a structured assessment and intervention package of simply written graphically-oriented printed materials to guide the patient and health counselor nutritionist health educator nurse or physician Computer Assisted innovative care used a user-friendly interactive computer assisted program permitting more sophisticated tailoring to individual needs conveying nutrition information in a vivid understandable format and extending the services of the health counselor The investigators used focus groups of patients with low literacy skills to aid in concept development and refinement of intervention delivery strategies Reliable and valid assessments of readability and comprehension helped further refine the materials
In Phase II a randomized trial was conducted to determine if the innovative modules produced a meaningful reduction in cholesterol and overall cardiovascular risk compared to standard care Subjects with high cholesterol and low literacy skills served by four community health centers were randomly assigned to one of four groups Innovative Care-Counselor Directed Innovative Care-Computer Assisted Standard Care and Usual Care for dietary treatment of cholesterol obesity and hypertension Standard Care involved the same amount of time and health counselor exposure as Innovative Care but used currently available materials Usual Care patients were referred to their usual provider for treatment After four months and again at one year changes in lipids blood pressure and weight were assessed
Phase Ill consisted of a feasibility study to test the ability of both innovative care modules to reach low literacy adults through county health departments worksites and churches Results of the feasibility assessment helped refine a dissemination strategy using the state health department as a centralized coordinating agency and county health departments to implement the interventions at the community level
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL046775 | NIH | None | httpsreporternihgovquickSearchR01HL046775 |