Proposed Data Collections Submitted for Public Comment and Recommendations

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Proposed Project: Project DIRECT: Phase 2 Evaluation of Impact of Multilevel Community Interventions—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Prevention and Control (CDC). Project DIRECT (Diabetes Intervention Reaching and Educating Communities Together) is the first comprehensive community based project in the United States to address the growing burden of diabetes in African Americans. The goal of the project is to use existing knowledge of diabetes risk factors and complications to implement community level interventions to reduce the prevalence and severity of diabetes in communities with large African American populations. A community in Raleigh, North Carolina was selected as the demonstration site for the project. An area in Greensboro, North Carolina was identified as a suitable comparison community. CDC, Division of Diabetes Translation (DDT) is collaborating with the state of North Carolina to implement and evaluate public health strategies for reducing the burden of diabetes in this predominantly African American community.

Project DIRECT has three distinct intervention components—Health Promotion, Outreach, and Diabetes Care. The goals of all three interventions are to reduce or prevent diabetes and its complications, but each has a different but complimentary approach. In 1996-1997, Project DIRECT implemented a baseline population-based survey. Interventions have been employed since then and continue to the present. A follow-up study is now required to evaluate the impact of the multilevel approach to diabetes prevention and control. Data from this project will be critical to CDC on-going efforts to reduce the burden of diabetes, and to determine whether a similar program could be implemented successfully in other communities. A pre-post design was selected for the evaluation to determine if any changes observed from these outcomes might be attributed to the interventions used in Project DIRECT by comparing changes in the intervention and comparison communities. The baseline study for the pre-post evaluation was conducted during 1996-1997.

In Phase 2, households in the Raleigh and Greensboro communities will be selected at random using mailing lists. An interviewer will verify the address and do an initial screening for eligible participants in the household. Eligible participants will be asked to participate in the study and will have to complete a consent form. All participants will be asked to complete an interview on their health status and lifestyle and will be measured for height and weight. Participants who self-report a history of diabetes will be asked additional questions (diabetes module) about their management of diabetes and its complications and other related health conditions.

All participants who self-report a history of diabetes and a sub-sample of those without diabetes will be invited to participate in a household examination that will include blood pressure and waist circumference measurement and a blood draw for laboratory analysis including glucose and lipids concentrations. For quality control purposes, a small sample of participants will be asked to do a short telephone interview to verify information collected during the general interview. The estimated annualized burden for this data collection is 3,946 hours.