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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | August 1992 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00005729 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | CVD Nutrition Education for Low Literacy ESL Students |
| Official Title ICMJE | |
| Brief 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. |
| 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 Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Natural History |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | December 1996 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | No eligibility criteria |
| Gender | Male |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00005729 |
| Responsible Party | |
| Study ID Numbers ICMJE | 4938 |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) |
| Verification Date | July 2000 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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