A Toolbox Approach to Obesity Treatment in Urban Safety-Net Primary Care Clinics: a Pragmatic Clinical Trial
There is a need for new strategies to improve the success of obesity treatment within the primary care setting.
To determine if patients offered low out-of-pocket cost weight management tools achieved more weight loss compared to usual care.
Twelve-month pragmatic clinical weight loss trial with a registry-based comparator group performed in primary care clinics of an urban safety-net hospital.
From a large clinical registry, we randomly selected 428 patients to have the opportunity to receive the intervention.
Medical weight management tools—partial meal replacements, recreation center vouchers, pharmacotherapy, commercial weight loss program vouchers, and a group behavioral weight loss program—for $5 or $10 monthly. Patients chose their tools, could switch tools, and could add a second tool at 6 months.
The primary outcome was the proportion of intervention-eligible patients who achieved ≥ 5% weight loss. The main secondary outcome was the proportion of on-treatment patients who achieved ≥ 5% weight loss.
Overall, 71.3% (305 of 428) had available weight measurement data/PCP visit data to observe the primary outcome. At 12 months, 23.3% (71 of 305) of intervention-eligible participants and 15.7% (415 of 2640) of registry-based comparators had achieved 5% weight loss (p < 0.001). Of the on-treatment participants, 34.5% (39 of 113) achieved 5% weight loss. Mean percentage weight loss was − 3.15% ± 6.41% for on-treatment participants and − 0.30% ± 6.10% for comparators (p < 0.001). The initially preferred tools were meal replacements, pharmacotherapy, and recreation center passes.
Access to a variety of low out-of-pocket cost weight management tools within primary care resulted in ≥ 5% body weight loss in approximately one quarter of low-income patients with obesity.
KEY WORDSweight management obesity primary care
The authors thank Denver Health’s patients who participated in this study and the PCPs and staff at intervention clinics. Angie Tong of the Rocky Mountain Poison & Drug Center assisted the design, construction, and support of the REDCap database. Kristin Breslin of Ambulatory Care Services provided support from the DH Data Warehouse.
Research reported in this work was primarily funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (IH-12-11-4571). Support also came from P30 DK048520 and T32 DK007446 (DS, SI). DS was also supported by NIH/NCATS Colorado CTSA Grant Number UL1 TR001082 and the VA Advanced Fellowship Program in Health Services Research and Development. The computer program used for participant education was developed by PHCC LP, Pueblo CO. Phentermine/topiramate ER was provided by Vivus Inc. Mountain View CA.
Compliance with Ethical Standards
DH and University of Colorado institutional review boards approved the trial.
Conflict of Interest
AGT served as a MedIQ consultant. DHB serves on the Data Safety Monitoring Board of Enteromedics, Inc. All remaining authors declare that they do not have a conflict of interest.”
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