Computer Assisted Instruction Weight Management for Low Literacy Populations

NCT ID: NCT00005693

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

1992-04-30

Study Completion Date

1995-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases Heart Diseases Obesity

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

No eligibility criteria
Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01HL048064

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4238

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Piloting a Patient Navigator Program for Weight Loss
NCT06972381 ACTIVE_NOT_RECRUITING NA