A Pilot of Customized Continuous Care Management of Obesity in Pre-Diabetics

Summary

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

Top Publications

  1. ncbi Algorithm for balancing both continuous and categorical covariates in randomized controlled trials
    Lan Xiao
    Department of Health Services Research, Palo Alto Medical Foundation Research Institute, 795 El Camino Real, Ames Building, Palo Alto, CA, United States
    Comput Methods Programs Biomed 108:1185-90. 2012
  2. pmc 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
    Veronica Yank
    Division of General Medical Disciplines, Stanford University School of Medicine, Medical School Office Building, 1265 Welch Road, Mail Code 5411, Stanford, CA 94305 5411, USA
    Contemp Clin Trials 34:126-35. 2013
  3. pmc Translating the Diabetes Prevention Program lifestyle intervention for weight loss into primary care: a randomized trial
    Jun Ma
    Department of Health Services Research, Palo Alto Medical Foundation Research Institute, Palo Alto, CA 94301, USA
    JAMA Intern Med 173:113-21. 2013
  4. pmc Translating an evidence-based lifestyle intervention program into primary care: lessons learned
    Andrea C Blonstein
    Palo Alto Medical Foundation Research Institute, Palo Alto, CA 94301, USA
    Health Promot Pract 14:491-7. 2013
  5. pmc Short-term weight loss patterns, baseline predictors, and longer-term follow-up within a randomized controlled trial
    Veronica Yank
    Department of Medicine, Stanford University School of Medicine, California, USA Department of Health Services Research, Palo Alto Medical Foundation Research Institute, California, USA
    Obesity (Silver Spring) 22:45-51. 2014
  6. pmc An easily accessible Web-based minimization random allocation system for clinical trials
    Lan Xiao
    Research Institute, Palo Alto Medical Foundation, Palo Alto, CA, United States
    J Med Internet Res 15:e139. 2013
  7. pmc Measurement of self-monitoring web technology acceptance and use in an e-health weight-loss trial
    Jun Ma
    1 Palo Alto Medical Foundation Research Institute, Palo Alto, California
    Telemed J E Health 19:739-45. 2013
  8. pmc Baseline obesity status modifies effectiveness of adapted diabetes prevention program lifestyle interventions for weight management in primary care
    Kristen M J Azar
    Palo Alto Medical Foundation Research Institute, 795 El Camino Real, Ames Building, Palo Alto, CA 94301, USA
    Biomed Res Int 2013:191209. 2013
  9. pmc Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE): a randomized controlled trial
    Jun Ma
    Palo Alto Medical Foundation Research Institute, Palo Alto, CA, USA
    BMC Fam Pract 10:71. 2009

Scientific Experts

  • J Ma
  • Veronica Yank
  • Lan Xiao
  • Randall S Stafford
  • Lisa Goldman Rosas
  • Sandra R Wilson
  • Kristen M J Azar
  • Andrea C Blonstein
  • Qiwen Huang

Detail Information

Publications9

  1. ncbi Algorithm for balancing both continuous and categorical covariates in randomized controlled trials
    Lan Xiao
    Department of Health Services Research, Palo Alto Medical Foundation Research Institute, 795 El Camino Real, Ames Building, Palo Alto, CA, United States
    Comput Methods Programs Biomed 108:1185-90. 2012
    ..All of the continuous and categorical covariates were well balanced, and the results were comparable to the comparison method...
  2. pmc 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
    Veronica Yank
    Division of General Medical Disciplines, Stanford University School of Medicine, Medical School Office Building, 1265 Welch Road, Mail Code 5411, Stanford, CA 94305 5411, USA
    Contemp Clin Trials 34:126-35. 2013
    ....
  3. pmc Translating the Diabetes Prevention Program lifestyle intervention for weight loss into primary care: a randomized trial
    Jun Ma
    Department of Health Services Research, Palo Alto Medical Foundation Research Institute, Palo Alto, CA 94301, USA
    JAMA Intern Med 173:113-21. 2013
    ..However, it has not been adequately translated into primary care...
  4. pmc Translating an evidence-based lifestyle intervention program into primary care: lessons learned
    Andrea C Blonstein
    Palo Alto Medical Foundation Research Institute, Palo Alto, CA 94301, USA
    Health Promot Pract 14:491-7. 2013
    ..Challenges remain, and we offer possible solutions to overcome them...
  5. pmc Short-term weight loss patterns, baseline predictors, and longer-term follow-up within a randomized controlled trial
    Veronica Yank
    Department of Medicine, Stanford University School of Medicine, California, USA Department of Health Services Research, Palo Alto Medical Foundation Research Institute, California, USA
    Obesity (Silver Spring) 22:45-51. 2014
    ..To examine weight loss patterns and predictors among participants in a primary care-based translation study of the Diabetes Prevention Program lifestyle intervention...
  6. pmc An easily accessible Web-based minimization random allocation system for clinical trials
    Lan Xiao
    Research Institute, Palo Alto Medical Foundation, Palo Alto, CA, United States
    J Med Internet Res 15:e139. 2013
    ..Minimization as an adaptive allocation technique has been recommended in the literature for use in randomized clinical trials. However, it remains uncommonly used due in part to a lack of easily accessible implementation tools...
  7. pmc Measurement of self-monitoring web technology acceptance and use in an e-health weight-loss trial
    Jun Ma
    1 Palo Alto Medical Foundation Research Institute, Palo Alto, California
    Telemed J E Health 19:739-45. 2013
    ..Using data from a randomized controlled trial of two e-health interventions, we evaluated the acceptance and use of a self-monitoring Web site for weight loss...
  8. pmc Baseline obesity status modifies effectiveness of adapted diabetes prevention program lifestyle interventions for weight management in primary care
    Kristen M J Azar
    Palo Alto Medical Foundation Research Institute, 795 El Camino Real, Ames Building, Palo Alto, CA 94301, USA
    Biomed Res Int 2013:191209. 2013
    ..To examine whether baseline obesity severity modifies the effects of two different, primary care-based, technology-enhanced lifestyle interventions among overweight or obese adults with prediabetes and/or metabolic syndrome...
  9. pmc Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE): a randomized controlled trial
    Jun Ma
    Palo Alto Medical Foundation Research Institute, Palo Alto, CA, USA
    BMC Fam Pract 10:71. 2009
    ..Translational research is needed to test real-world models of lifestyle interventions in primary care settings...