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.
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.
- 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 startAug 1992
- Study completionDec 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 San Diego State UniversityThe 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
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
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 9386952Frack 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CVD Nutrition Education for Low Literacy ESL Students
- ClinicalTrials.gov ID
- NCT00005729
- Acronym / sponsor ID
- 4938
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 1992
- Study completion
- Dec 1996
- 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 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.
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.
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 12 Jan 2016.
- Background: PubMed 9386952Woodruff 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.
- Background: PubMed 9088450Frack 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.
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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 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.