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Cardiovascular DiseasesNCT00005729

CVD Nutrition Education for Low Literacy ESL Students

An observational study of Cardiovascular Diseases and Heart Diseases, run by San Diego State University.

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 promote cardiovascular health through nutritional education in a low literacy population enrolled in English as a Second Language (ESL) courses in the San Diego Community College District. 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
Aug 1992to Dec 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 promote cardiovascular health through nutritional education in a low literacy population enrolled in English as a Second Language (ESL) courses in the San Diego Community College District.

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:

An estimated 1,800 students in 90 different classes were randomly assigned to the special nutritional intervention or an attention-control condition where a certification course in cardiopulmonary resuscitation (CPR) was taught. Specially trained ESL teachers actually led the intervention classes, which were designed in accordance with the NHLBI and American Red Cross guidelines, respectively. Specific educational content for the intervention group included sources of dietary fat and cholesterol nutrients affecting blood pressure, basic shopping skills, food preparation skills , and dealing with special occasions, i.e., potlucks. A booster session was held to monitor progress, provide reinforcement for success or additional problem solving for difficulties, review materials, and plan maintenance. Consistent with a Social Learning (Cognitive) Theory (SLT) framework, all sessions included modeling*, role playing, corrective feedback and social reinforcement, homework, and confidence building activities. With attention to the specific needs of this population which was low in literacy (at least in English), the smallest amount of information necessary was presented, each point was made as vividly as possible, participants restated and otherwise demonstrated their mastery of the material, and frequent repetition was used. A substantial period of formative research emphasized specific adaptations of existing material to make it appropriate for this population.

Measurement occurred at baseline, at three months and at a six months follow-up. Measures included blood pressure, total cholesterol, height/weight, waist and hip circumference, 24-hour dietary recall, SLT-based knowledge, attitude and behavior variables, the Comprehensive Adult Student Assessment System (CASAS) Life Skills Reading Test and Spanish literacy through the Cloze technique. All self-report measurement except the CASAS was conducted in English or Spanish, primarily through oral interview. SLT knowledge, attitude, and behavioral measures of instructors in study and non-study classes were also assessed.

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 startAug 1992
  3. Study completionDec 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
NCT00005729
Sponsor's protocol ID
4938
Other IDs
R01HL046776
Status last verified
Jul 2000
First submitted
25 May 2000
Last updated
12 Jan 2016
Results posted
No

Publications

  • Woodruff SI, Zaslow KA, Candelaria J, Elder JP. Effects of gender and acculturation on nutrition-related factors among limited-English proficient Hispanic adults. Ethn Dis. 1997 Spring-Summer;7(2):121-6.

    PubMed 9386952
  • Frack SA, Woodruff SI, Candelaria J, Elder JP. Correlates of compliance with measurement protocols in a Latino nutrition-intervention study. Am J Prev Med. 1997 Mar-Apr;13(2):131-6.

    PubMed 9088450

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Heart Diseases, run by San Diego State University.

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 12 Jan 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 NCT00005729, which also lists 2 linked publications.

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 12 Jan 2016.

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