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Cardiovascular DiseasesNCT00005728

Nutrition Education

An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To utilize a community-based approach to nutrition education in an urban African American community. Read more about this study

Who is it for?
Ages Up to 100 years, men only
Conditions the study is for
Cardiovascular Diseases, Heart Diseases
How many people
Not given
Where
No sites listed yet
Study dates
May 1992to Apr 1996
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 100 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

No eligibility criteria

About this study

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.

Medical subject headings
Cardiovascular Diseases, Heart Diseases

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startMay 1992
  3. Study completionApr 1996

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005728
Sponsor's protocol ID
4937
Other IDs
R01HL046757
Status last verified
Jul 2000
First submitted
25 May 2000
Last updated
18 Feb 2016
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005728, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.

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