A Toolbox Approach to Obesity Treatment in Primary Care
Condition: Obesity
MeSH terms: Obesity
Intervention: Commercial weight loss program; Colorado Weigh; Meal replacements; Obesity pharmacotherapy; Recreation center passes
Intervention description: 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
Intervention MeSH terms: Topiramate; Phentermine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4730.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. BMI > 30 kg/m2 and < 45 kg/m2

          2. Any one of the following (weight-related) diagnoses: type 2 diabetes or pre-diabetes,
             including those treated with glucose lowering medications; hypertension, including
             patients treated with anti-hypertensive medications; hyperlipidemia, including those
             treated with lipid lowering agents; atherosclerotic cardiovascular disease, including
             coronary heart disease, cerebrovascular disease, or peripheral vascular disease;
             obstructive sleep apnea

          3. Visited their primary care provider (PCP) at least twice during the past 12 months,
             including once in the last 6 months

        Exclusion Criteria:

        Heart attack or stroke within the past 6 months; cancer treated within the past 5 years,
        except for non-melanoma skin cancer or localized prostate cancer; other medical
        contraindications to weight loss (e.g., end-stage renal disease, cirrhosis); active
        substance abuse; current treatment for bipolar disorder or schizophrenia; discretion of PCP
        (see below)