Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005728
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
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:
2000-07
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 utilize a community-based approach to nutrition education in an urban African American community
Detailed Description:
BACKGROUND
The investigator originally applied for the grant in response to 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 However the grant was not awarded as part of the RFA
DESIGN NARRATIVE
The overall goal was to achieve a significant increase in the proportion of African Americans consuming a low fat low salt prudent diet and to increase the proportion with optimal levels of blood pressure and total blood cholesterol The specific aims were to 1 assess the eating patterns and attendant nutrition literacy issues in urban African Americans 2 determine the effectiveness of a lay volunteer-mediated multimodal culturally-specific church-based intervention compared with a strategy using solely written and visual self-help materials 3 determine the impact of an intensive culturally-specific nutrition education intervention on the selection of prudent low fat low salt alternatives when compared with the usual approaches to influencing food selection in major markets and fast-food restaurants and 4 develop a process module which allowed generalization of this community-based technique to other low literacy high cultural-specificity groups
The study had three phases and utilized a social-marketing approach Phase I the first year of the study was a community diagnosis consisting of a population-based random-digit-dialing survey and a series of focus groups to define eating patterns and nutrient intake in their social context in the African American population Community focus groups were conducted to design culturally-specific nutrition education modules to be used in two subsequent randomized trials Phase I also consisted of the adaptation of existing instruments to determine nutrition literacy levels comprehension and the readability specifically in this population
Phase II in years two three and the first six months of year four of the study was comprised of a randomized trial of a nutrition education module administered through trained lay nutrition counselors in East Baltimore churches compared with churches which received only self-help materials designed for the literacy level Outcomes included assessment of total calories from fat from saturated fat cholesterol in mgday and blood pressure and blood cholesterol levels measured one six and 12 months after the intervention
Phase III conducted in year four consisted of a randomized trial of an intensive nutrition intervention which was designed for the culture and was compared with usual advertising and food-selection influence techniques in eight fast food restaurants and four large food markets in East Baltimore Outcomes included the shift in sales from high to low fat and salt alternatives as determined by computerized sales and inventory data during the intervention and two weeks following the intervention All interventions in Phase II and III evolved from the focus groups and survey work performed in Phase I
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 investigator originally applied for the grant in response to 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 However the grant was not awarded as part of the RFA
DESIGN NARRATIVE
The overall goal was to achieve a significant increase in the proportion of African Americans consuming a low fat low salt prudent diet and to increase the proportion with optimal levels of blood pressure and total blood cholesterol The specific aims were to 1 assess the eating patterns and attendant nutrition literacy issues in urban African Americans 2 determine the effectiveness of a lay volunteer-mediated multimodal culturally-specific church-based intervention compared with a strategy using solely written and visual self-help materials 3 determine the impact of an intensive culturally-specific nutrition education intervention on the selection of prudent low fat low salt alternatives when compared with the usual approaches to influencing food selection in major markets and fast-food restaurants and 4 develop a process module which allowed generalization of this community-based technique to other low literacy high cultural-specificity groups
The study had three phases and utilized a social-marketing approach Phase I the first year of the study was a community diagnosis consisting of a population-based random-digit-dialing survey and a series of focus groups to define eating patterns and nutrient intake in their social context in the African American population Community focus groups were conducted to design culturally-specific nutrition education modules to be used in two subsequent randomized trials Phase I also consisted of the adaptation of existing instruments to determine nutrition literacy levels comprehension and the readability specifically in this population
Phase II in years two three and the first six months of year four of the study was comprised of a randomized trial of a nutrition education module administered through trained lay nutrition counselors in East Baltimore churches compared with churches which received only self-help materials designed for the literacy level Outcomes included assessment of total calories from fat from saturated fat cholesterol in mgday and blood pressure and blood cholesterol levels measured one six and 12 months after the intervention
Phase III conducted in year four consisted of a randomized trial of an intensive nutrition intervention which was designed for the culture and was compared with usual advertising and food-selection influence techniques in eight fast food restaurants and four large food markets in East Baltimore Outcomes included the shift in sales from high to low fat and salt alternatives as determined by computerized sales and inventory data during the intervention and two weeks following the intervention All interventions in Phase II and III evolved from the focus groups and survey work performed in Phase I
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 |
|---|---|---|---|
| R01HL046757 | NIH | None | httpsreporternihgovquickSearchR01HL046757 |