Cardiovascular DiseasesNCT00005728
Nutrition Education
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- 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.
- First posted26 May 2000 (estimated)
- Study startMay 1992
- Study completionApr 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Education
- ClinicalTrials.gov ID
- NCT00005728
- Acronym / sponsor ID
- 4937
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- May 1992
- Study completion
- Apr 1996 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 10600060Becker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.