Home-based Prediabetes Care in Acoma Pueblo

The investigators are conducting a prospective, randomized clinical trial of 'Home Base Diabetes Care (HBDC)' versus usual care (delayed HBDC beginning 12 months after enrollment) among 150 Acoma citizens with prediabetes from approximately 60 households. The household will serve as the unit of randomization to prevent cross-contamination of the study groups. The investigators hope to demonstrate that HBDC will result in improved patient activation and adherence, improved health-related quality of life (HRQOL), and ultimately, improved diabetes-related health outcomes. Standard, usual care is an appropriate comparison group because it is widely available in Acoma through IHS and because there are a number of other existing resources in Acoma that participants can access to achieve their healthcare goals if they choose to do so. Improved Patient Activation may drive increased utilization of these existing resources. The study will be non-blinded.

This is a 5-year study with screening and rolling enrollment beginning during the first year. Participants randomized to the HBDC group will receive 16 weeks of the intervention and will subsequently have one additional data collection visit 12 months after the intervention (total participation approximately 16 months). Participants randomized to the usual care group (delayed HBDC) will begin the HBDC intervention at 12 months. The intervention will be 16 weeks and a final data collection visit will be conducted 12 months after the intervention (total participation approximately 28 months). During the HBDC intervention, both groups will receive 8 home visits over 16 weeks (every other week) and 3 text messages per week. Data analysis and dissemination will be conducted during the final year of the study.

The investigators will use community health representatives (CHRs) in collaboration with licensed personnel at the University of New Mexico Health Sciences Center (UNM HSC) to provide a comprehensive home-based intervention to prevent diabetes and improve health through counseling around lifestyle interventions such as diet and exercise. CHRs will make regularly scheduled home visits and they will have a lap top computer with internet access and telemedicine contact with personnel at UNM HSC (Dr. Bouchonville, in his role as Medical Director/Facilitator of the weekly Endo ECHO sessions) for ongoing review of care plans, and management of prediabetes, hypertension, dyslipidemia, and kidney disease according to current American Diabetes Association guidelines. In a collaborative manner, the participant and healthcare team will set appropriately realistic treatment goals. Professional personnel from UNM Clinical and Translational Science Center (e.g., physicians and bio-nutritionists) and HSC (Endo ECHO) will serve as consultants to the primary dyad.

All subjects randomized to the HBDC arm will be visited by a CHR in their home at least every two weeks for the duration of the 16 weeks intervention. All enrolled members of a household unit will attend these visits. Given 25-35 households per study arm (comprising 75 participants each) and two full time CHRs working on the study, each CHR will be responsible for approximately 15 households and up to 30 home visits per month, although this latter estimate is high given that rolling enrollment will occur over a 2-3 year period. Each visit will last one hour and will cover curriculum materials agreed upon by the study team and prioritized by the participants. Other members of the household who do not have prediabetes or who are not enrolled in the study will also be allowed to participate in the sessions if they wish, and all subjects will be encouraged to keep their IHS appointments.

Primary outcome - To demonstrate that prediabetes risk profiles will improve with HBDC as compared to usual care: To evaluate the effectiveness of the HBDC intervention, the investigators will assess between-group changes in the T2D risk profile of study participants using change in Body Mass Index and A1c as our primary outcome parameters. To reproduce real-life community healthcare conditions, A1c will be assessed in both study groups with POC as an indicator of 90 day glucose homeostasis. BMI will be determined using a SECA 876 Floor Scale (SECA Inc., Chino, CA), and height will be assessed using SECA 217 Portable Stadiometer with floor scale adapter. Study participants in the intervention arm will be counseled to lose 5% of their body weight over the course of the 12-month study. This is a reasonable weight-loss goal based on the following: (1) in our previous extended family-based studies, 45.9% were obese, and all of the randomized participants will have BMI >27 kg/m2; (2) in our previous study, participants in the lifestyle intervention successfully met weight goals over a relatively short period of time; and (3) eliminating or expending enough energy to burn 500 calories/day, while making no other changes, will result in a weight loss of up to 0.5 kg per week.