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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Planning Grant (R34)
Project #
5R34DK080878-02
Application #
7755415
Study Section
Special Emphasis Panel (ZDK1-GRB-1 (O1))
Program Officer
Staten, Myrlene A
Project Start
2009-01-10
Project End
2011-12-31
Budget Start
2010-01-01
Budget End
2011-12-31
Support Year
2
Fiscal Year
2010
Total Cost
$235,714
Indirect Cost
Name
Palo Alto Medical Foundation Research Institute
Department
Type
DUNS #
622276137
City
Palo Alto
State
CA
Country
United States
Zip Code
94301
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Rosas, Lisa G; Lv, Nan; Azar, Kristen et al. (2015) Applying the Pragmatic-Explanatory Continuum Indicator Summary Model in a Primary Care-Based Lifestyle Intervention Trial. Am J Prev Med 49:S208-14
Yank, Veronica; Xiao, Lan; Wilson, Sandra R et al. (2014) Short-term weight loss patterns, baseline predictors, and longer-term follow-up within a randomized controlled trial. Obesity (Silver Spring) 22:45-51
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Azar, Kristen M J; Xiao, Lan; Ma, Jun (2013) Baseline obesity status modifies effectiveness of adapted diabetes prevention program lifestyle interventions for weight management in primary care. Biomed Res Int 2013:191209
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Xiao, Lan; Huang, Qiwen; Yank, Veronica et al. (2013) An easily accessible Web-based minimization random allocation system for clinical trials. J Med Internet Res 15:e139
Xiao, L; Yank, V; Wilson, S R et al. (2013) Two-year weight-loss maintenance in primary care-based Diabetes Prevention Program lifestyle interventions. Nutr Diabetes 3:e76
Ma, Jun; Yank, Veronica; Xiao, Lan et al. (2013) Translating the Diabetes Prevention Program lifestyle intervention for weight loss into primary care: a randomized trial. JAMA Intern Med 173:113-21
Yank, Veronica; Stafford, Randall S; Rosas, Lisa Goldman et al. (2013) Baseline reach and adoption characteristics in a randomized controlled trial of two weight loss interventions translated into primary care: a structured report of real-world applicability. Contemp Clin Trials 34:126-35

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