ClinicalTrials.gg
CompletedNCT00005728Updated Feb 18, 2016

Nutrition Education

An observational study in Cardiovascular Diseases and Heart Diseases, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed. Open to male participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2016-02-18.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

Study type
Observational
Ages
Up to 100 Years
Sex
Male
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Study summary

To utilize a community-based approach to nutrition education in an urban African American community.

Read the 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 mg/day 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.

02

Conditions studied

  • Cardiovascular Diseases
  • Heart Diseases
03

In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

Browse Cardiovascular Diseases studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,143 studies on the registry; 72 are open to participants now.

Of its 58 completed or terminated interventional studies of FDA-regulated products, 50 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

No eligibility criteria

05

Study design

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Becker DM, Yanek LR, Koffman DM, Bronner YC. Body image preferences among urban African Americans and whites from low income communities. Ethn Dis. 1999 Autumn;9(3):377-86. PubMed 10600060 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 1992 and a completion of Apr 1996. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 25, 2000
First posted
May 26, 2000
Start
May 1992
CompletionActual
Apr 1996
Last update
Feb 18, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00005728
First posted
May 26, 2000
Start date
May 1992
Completion
Apr 1996
Last update
Feb 18, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2000. You cannot join it, but the record below documents what was studied.

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