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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | April 1992 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00005693 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Computer Assisted Instruction Weight Management for Low Literacy Populations |
| Official Title ICMJE | |
| Brief Summary | To develop and evaluate a computer assisted instruction (CAI) weight management program in an adult population with low literacy at Sheehan Memorial Hospital's Family Care Center (FCC), an outpatient clinic serving the inner city of Buffalo, New York. |
| Detailed Description | BACKGROUND: This was the first study in patient care informatics in which nutrient analysis methodology was used on a day-to-day basis to motivate low literate individuals to improve their food choice behavior and physical activity. The deliverables of this investigation included revised and enhanced software, professional documentation, and a participant workbook. These materials were designed so that they could be integrated into any risk factor reduction program for low literacy populations. DESIGN NARRATIVE: The CAI featured voice recognition, giant cursor movement, and a graphics-based environment using pictures to facilitate an exceptionally easy to use and understand software program and booklet. The voice recognition technology was linked with compact disk read only memory (CD ROM) to visually display food choices and physical activities for ease of recording data by the individual. The software was formatted so that health professionals could select preference levels which corresponded to the motivational level of the individual. The four-session CAI intervention had two planned maintenance sessions. The output was personalized and in color. It was designed to identify problematic foods in the diet, improve food selections, and increase physical activity. Stars were printed for adherence to individual goals. One hundred and fifty (150) men and 150 women, between age 20 and age 44, with a reading level of 8th grade or less, who were between 20 percent and 40 percent over their ideal body weight, were randomly assigned to three groups. The design compared a control group without the intervention, a group experiencing the CAI intervention and hands-on computer use, and a group experiencing the intervention but not the CAI component or computer use. All groups were pretested, posttested, and follow-up tested at six months and twelve months following baseline. The primary outcome measures were weight loss, nutrient intake, and physical activity. Data were analyzed using a two-way analysis of covariance and appropriate t-tests. |
| 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 | March 1995 |
| 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 | NCT00005693 |
| Responsible Party | |
| Study ID Numbers ICMJE | 4238 |
| 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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