A Toolbox Approach to Obesity Treatment in Primary Care
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      Obesity is common, causing many medical problems in adults (e.g., diabetes, hypertension,
      high cholesterol, sleep apnea, heart attack, strokes). A range of treatments have shown to be
      effective for treating obesity. Treatments include lifestyle modification, meal replacements,
      and weight loss medication. Most primary care settings do not provide much obesity treatment,
      though, as primary care providers (PCPs) are not well trained and because reimbursement for
      treatments is not consistent.

      Hypothesis: If PCPs have training in weight management and if most costs of treatment are
      reimbursed, we surmise that a "toolbox" of treatments can produce a clinically important
      weight loss amount in a large group of patients.

      Design: We propose to establish a registry of obese patients with at least one common medical
      condition related to their weight. From the registry, we will randomly select 350 people to
      be offered treatments to assist with weight loss. The remainder of the registry's patients
      can still receive obesity treatment but will not be reimbursed. We will conduct the study at
      Denver Health, a large public health care system that treats a low income, ethnically diverse
      population. All 350 patients will be offered some self-monitoring tools for weight management
      and the chance to do a computer assessment to select the right treatment for weight loss.
      Patients who complete this and record their food intake and physical activity for 1 week will
      be offered a "Level 2" treatment for weight loss. Level 2 treatments include: a voucher for a
      commercial weight loss program; intensive group weight loss counseling; meal replacements;
      gym membership; or weight loss medication. Patients will choose which treatment they want,
      with the approval of their PCP. Researchers at Denver Health will help with the computer
      assessment and dispensing the treatments. We are interested in what percentage of patients
      lose at least 5% of their starting weight. We will also explore changes in glucose, blood
      pressure, and cholesterol, and we will look at how much this intervention costs and whether
      patients need less medication for their weight-related conditions at the end of the study.

      Impact: If the study is successful, we plan to take the results to the leaders at Denver
      Health to see if they will make obesity treatment more broadly available for all patients
      there.
    

Detailed description: 
      Background: Obesity is prevalent and is a root cause of many common medical conditions
      affecting U.S. adults. A range of treatment options have demonstrated efficacy in producing
      weight loss and reducing health risks in randomized controlled trials. However, very little
      obesity treatment is currently delivered in most primary care settings. Inadequate
      reimbursement for treatment modalities and a lack of systematic training of primary care
      providers (PCPs) are two of the major barriers to more widespread treatment.

      Hypothesis: If PCPs are given training and support for weight management, and if treatment
      options with proven efficacy are offered to obese adults with weight related co-morbidities
      with the majority of the treatment cost reimbursed, then clinically meaningful weight loss
      will be produced in a significant number of these individuals at a reasonable cost.

      Design: This application proposes a 12 month intervention trial among obese adults cared for
      at 4 primary care clinics affiliated with Denver Health (DH), an integrated health care
      system serving an ethnically diverse medically underserved population. From among a large
      population of patients (~8,000) with obesity and at least one co-morbid condition, 350
      individuals will be randomly selected to be offered a "toolbox" of treatment options. The
      remainder will be assigned to a control condition. The "toolbox" will include: 1) meal
      replacements; 2) group weight loss counseling; 3) membership at recreation centers; 4)
      pharmacotherapy with phentermine; and 5) other options. Patients in the intervention arm will
      undergo an initial evaluation using an "expert systems" computer program. They will then be
      required to self-monitor diet and physical activity before gaining access to the higher cost
      weight management services in the toolbox. Primary care providers will help patients choose
      treatment approaches, encourage adherence, and monitor success. Patient Navigators will
      assist patients in accessing prescribed treatments. The primary outcome will be the fraction
      of patients in each group who achieve a 5% weight loss after 12 months of intervention.
      Secondary outcomes will include uptake and utilization of treatment options, changes in
      cardiovascular disease risk factors, and other health care utilization, in particular
      outpatient medications for diabetes, hypertension, and lipids. While the treatment modalities
      to be used in this trial are not new, an intervention delivering a toolbox of weight
      management services in a safety net clinical setting and examining the effect on health care
      utilization is innovative. The submitted letters of support attest to the need for more data
      so that health care providers and payers can make evidence-based decisions regarding the
      provision of obesity treatment to large patient populations.

      Impact: A positive result would encourage the broader adoption of a toolbox approach to
      weight management in primary care settings. A negative result would strongly suggest that
      even with a "best case scenario" of training and support for obesity treatment, the primary
      care clinic is not an effective route of delivery for weight management. Either result would
      be important in shaping future policy decisions about obesity treatment.
    

Intervention name(s): Commercial weight loss program; Colorado Weigh; Meal replacements; Obesity pharmacotherapy; Recreation center passes
Intervention type(s): Behavioral; Behavioral; Dietary Supplement; Drug; Behavioral
Intervention description(s): vouchers for Weight Watchers; Group behavioral weight loss program; Health Management Resources meal replacement products (shakes and entrees); Phentermine or phentermine-topiramate (Qsymia); 1 year pass to a Denver recreation center
Other intervention name(s): Phentermine or phentermine-topiramate (Qsymia)
Intervention MeSH terms: Topiramate; Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment