David R Saxon1,2, Erin L Chaussee3,4, Elizabeth Juarez-Colunga3,4, Adam G Tsai5, Sean J Iwamoto6,7, Rebecca B Speer8, Hilde Heyn8, Elizabeth H Kealey9, Daniel H Bessesen6,8,9. 1. Division of Endocrinology, Metabolism and Diabetes, University of Colorado School of Medicine, Aurora, CO, USA. david.saxon@ucdenver.edu. 2. Denver/Seattle Center of Innovation for Veteran-Centered and Values Driven Care, VA Eastern Colorado Health Care System, Denver, CO, USA. david.saxon@ucdenver.edu. 3. Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO, USA. 4. Adult and Child Consortium for Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine, Aurora, CO, USA. 5. Kaiser Permanente, Denver, CO, USA. 6. Division of Endocrinology, Metabolism and Diabetes, University of Colorado School of Medicine, Aurora, CO, USA. 7. Division of Endocrinology, Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, CO, USA. 8. Denver Health Medical Center, Denver, CO, USA. 9. Anschutz Health and Wellness Center, University of Colorado School of Medicine, Aurora, CO, USA.
Abstract
BACKGROUND: There is a need for new strategies to improve the success of obesity treatment within the primary care setting. OBJECTIVE: To determine if patients offered low out-of-pocket cost weight management tools achieved more weight loss compared to usual care. DESIGN: Twelve-month pragmatic clinical weight loss trial with a registry-based comparator group performed in primary care clinics of an urban safety-net hospital. PARTICIPANTS: From a large clinical registry, we randomly selected 428 patients to have the opportunity to receive the intervention. INTERVENTIONS: 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. MAIN MEASURES: 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. KEY RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01922934.
RCT Entities:
BACKGROUND: There is a need for new strategies to improve the success of obesity treatment within the primary care setting. OBJECTIVE: To determine if patients offered low out-of-pocket cost weight management tools achieved more weight loss compared to usual care. DESIGN: Twelve-month pragmatic clinical weight loss trial with a registry-based comparator group performed in primary care clinics of an urban safety-net hospital. PARTICIPANTS: From a large clinical registry, we randomly selected 428 patients to have the opportunity to receive the intervention. INTERVENTIONS: 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. MAIN MEASURES: 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. KEY RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01922934.
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