A Pilot of Customized Continuous Care Management of Obesity in Pre-Diabetics
Principal Investigator: Jun Ma
Abstract: DESCRIPTION (provided by applicant): Excess body weight is an epidemic in the United States. Obese or overweight individuals with pre-diabetes are at high risk of progression to diabetes. Weight loss is the dominant predictor of reduced diabetes incidence in these individuals. Intensive lifestyle interventions delivered in frequent, face-to-face, individual sessions are effective, at least when delivered in a research setting, in achieving and maintaining clinically significant (=5%) weight loss in pre-diabetic populations. Alternative, more efficient delivery modalities, particularly group therapy and Internet-based lifestyle intervention, have demonstrated efficacy. However, their effectiveness, cost- effectiveness, generalizability, and sustainability in routine primary care settings have not been investigated. This application responds to the call for "Planning Grants for Translational Research for the Prevention and Control of Diabetes and Obesity." We propose pilot testing a Customized Continuous Care Management (CCCM) model with patients who are obese or overweight and have impaired fasting glucose in a primary care setting. The CCCM obesity intervention is based on weight loss and maintenance strategies already proven effective for use in multi-ethnic populations. The 6-month intervention will include 2 distinct stages: a 2-month intensive stage that will involve a group orientation and a 6-week weight loss class and a subsequent maintenance stage that will rely on an Online Disease Management system for ongoing self-monitoring and e-counseling. The online system is fully integrated with a leading, commercially available electronic health record (EHR) system that includes a personal health record and secure patient-clinician messaging capabilities. Our specific aims are to: 1. Conduct a 2-arm pilot trial at the Los Altos Center of the Palo Alto Medical Foundation, a large, community- based, multi-specialty group practice. We will randomize 130 non-diabetic, non-pregnant patients =18 yrs who have a body mass index (BMI) =25 kg/m2 and impaired fasting glucose of 100-125 mg/dL to CCCM or usual care. 2. Evaluate the effectiveness of CCCM in improving patient outcomes, including BMI (primary outcome), waist circumference, clinical and lifestyle risk factors, and quality of life. Our primary hypothesis is that CCCM patients will experience greater reductions in BMI over 6 months than those in usual care. We will examine moderators and mediators of the intervention effects. We will use the estimates of response to the intervention and variation therein to inform a subsequent, full-scale randomized clinical trial (RCT). 3. Evaluate the implementation feasibility and potential sustainability of CCCM using process measures (e.g., feasibility of recruitment and retention, intervention uptake and adherence, participant and provider satisfaction). This information will guide our efforts to evaluate the reach, adoption, implementation, and maintenance of CCCM in the subsequent RCT. If proven successful in the current and subsequent evaluations, the CCCM will be transitioned to a PAMF- wide program and also will have the potential to be widely disseminated to health systems with existing EHRs. PUBLIC HEALTH RELEVANCE: Weight loss in obese or overweight patients with additional risk factors, such as impaired fasting glucose, is of high priority in primary care settings;however, obesity management in these settings has thus far been largely a failure. In this application, we propose pilot-testing a Customized Continuous Care Management (CCCM) program in which evidence-based weight loss and maintenance strategies will be delivered in group sessions for initial, intensive weight loss therapy and via an Online Disease Management system for ongoing maintenance. If proven successful in the current and subsequent evaluations, our CCCM program has the potential to provide a blueprint for instituting customized, continuous care management for obesity and other chronic conditions in a range of primary care settings.
Funding Period: -------------------- - --------------------
more information: NIH RePORT
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1 Palo Alto Medical Foundation Research Institute, Palo Alto, California
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