People with intellectual and developmental disabilities (IDD) experience poor nutrition, obesity, and other serious health problems at significantly higher rates than those in the general public. The incidence of obesity among people with IDD is 50%, almost double the rate exhibited by mainstream Americans. Similar discontinuities exist with diseases such as diabetes and hypertension within this population. There are genetic, metabolic, and pharmacological reasons for these elevated rates and previous attempts to improve the health of people with IDD, employing exercise routines and education, have been neither efficacious nor sustainable. Recent programmatic interventions focusing on diet and the nutritional intake of people with IDD have been much more successful in improving their quality of life and dietary patterns, as well as reducing the rate of serious secondary medical conditions. A Phase I study at a social service agency that residentially supports people with IDD, found that caregivers in group homes experienced significant increases in their knowledge, attitudes and behaviors towards nutrition and healthy eating. And through using these web-based interventions and the documentation from the Mainstay nutrition program, the people with IDD supported by the caregivers have experienced material improvements in Healthy Eating Indexes, Body Mass Indices, health status indicators, as well as more cost-effective, diverse meals and menus. The Phase II randomized trial will occur over a larger sample size that is more geographically dispersed. It will test the differing impact of a range of revised interventions on the knowledge, attitudes and behaviors of the staff that support people with IDD, along with measuring the nutrition, health and operating parameters mentioned above among the individuals with IDD. In this way, we will determine the tradeoff among efficacy, cost and implementation outcomes for various intervention alternatives. The results of the larger trial will have significance to the quality of life and quality of health for the five million people with IDD in the nation. In addition the outcomes will influence policy for the organizations as well as the state and federal government entities providing services and funding to this population. OBJECTIVES: The Mainstay Phase I trial produced statistically significant, meaningful results across a range of outcomes - knowledge, attitudinal and behavioral, particularly the menus designed, food ingredients procured, and meals prepared and consumed by people with intellectual or developmental disabilities (IDD). To expand the availability of these supports to more customers, and in order to understand the uptake and efficacy of multiple variations of our current or proposed interventions, we will conduct research over a statistically representative number of group homes in multiple states. Four objectives will be achieved during the Phase II, multi-outcomes research. 1), the scope of the original online intervention package will be revised and expanded. Additional curricula content will be created. The ease of use of the Pinpoint Menu Guide (PMG) software will be enhanced by simplifying the interface and developing an online tutorial. System documentation to supplement staff and people with IDD developing nutritious, cost-effective, flavorful meals and menus will increase. Ongoing staff interaction will be provided via email with the Mainstay chef on food shopping, menu-planning and cooking topics for the Online Services version of this project. 2), the web-based instructional materials and the online recipe planning software will be enhanced to enable delivery via DVD and facsimile, to enable their use within group homes that do not have current access to computers. a), the revised text, image, video, and menu-development materials will be ported to DVD format for use in a second set of group homes that do not have computers but where the DVD plus Facsimile technologies are available; b), the printed recipe content, the pictorial recipes, and the Pinpoint Menu Guide will be converted for delivery to a third set of houses that do not have computers or DVD players but do have onsite fax machines in the Facsimile Only condition. 3) Group homes from a large provider of services to IDD persons living in community-based settings around the United States, will be assigned to the three Intervention conditions (Internet Services, DVD plus Facsimile, and Facsimile Only) and to the non-treated Control Group. The individual houses in each condition in this non-equivalent control group study design will be matched on characteristics of the staff (such as educational level, years of experience working in group homes) and on resident characteristics (e.g., age, gender, Functional Quotient level) during at the start-up of this project. 4), a range of process and outcome variables will be collected from house staff, group home residents, and program administrators at baseline, during the course of the study, and at the end of the study period. Our research team and statistical staff will examine the impact of the interventions on the above outcomes and we will conduct between-group analyses of nutritional intake patterns, health and program costs for the four sets of group homes. This qualitative information will help interpret the quantitative research findings and to improve the effectiveness and the efficiency of later Mainstay service offerings. APPROACH: A quasi experimental, non-equivalent control group, pre-test - post-test, stepped intensity design will be used to assess the impact of the Internet Services, DVD plus Facsimile, and the Facsimile Only program interventions vis-a-vis the non-treated Control condition. Four sets of group homes will be included in the study, with thirty-five houses and approximately 175 residents assigned to each condition. Within the three sets of intervention houses, content and interactivity will be limited by the computers, DVD and facsimile equipment in the house. Staff in Control group homes will not receive any nutrition education, health information, menu-planning, or food preparation instruction during the project period. Given that computers and broadband communications are available in many but not all of the group home sites, randomization of group homes to conditions will not be feasible. This is the reason that we have elected to use a non-equivalent control group design. In selecting locations for the study we will identify group homes with approximately equal numbers of staff with equivalent levels of educational attainment and experience working with I/DD persons. We will also screen on the number of residents, and on their demographic characteristics, functional quotients (similar to an IQ but including skills and behavior) and health status in selecting sites for the study. The control group will be selected at random from the screened population of group homes and used by itself, rather than in conjunction with the intervention groups, in estimates of study parameters. Program impact will be assessed on a pre-post and continuing basis at the staff level, the resident level, and the group home/organizational level. The primary outcome measures for staff will include changes in their knowledge of nutrition and health information, and self-efficacy ratings for menu-planning, food-shopping and meal-preparation activities. The impact of the program on resident health status will be evaluated using both objective and subjective indicators. In addition to the staff collected measures of resident height, weight, percent body fat, Waist-Hip Ratio, and BMI, the PCS and MCS dimensions from the SF-8 survey will be used to assess the health related quality of life of the subjects in the four conditions. Organizational impact data, such as operational efficiency, will be gathered. Mainstay research staff will work with dieticians and biostatistics staff from the Feinberg School of Medicine at Northwestern in programming the study database, managing data collection and conducting the analyses of study data. We will work with a health economics consultant in conducting cost-effectiveness analyses. Specifically, we will measure the input costs of each intervention (viz., time and material costs associated with developing the program materials and food costs) so we can ascertain cost differences between each condition and compared with the Control condition. We will also assess the incremental cost-effectiveness of the interventions relative to each other and to the Control condition using the change in BMI as the measure of effectiveness
