Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00005693 |
| Other study ID # |
4238 |
| Secondary ID |
R01HL048064 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 25, 2000 |
| Last updated |
March 15, 2016 |
| Start date |
April 1992 |
| Est. completion date |
March 1995 |
Study information
| Verified date |
July 2000 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial 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.
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.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
