{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T14:45:52Z","timestamp":1787496352549,"version":"build-2736575974"},"reference-count":21,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2016,10,21]],"date-time":"2016-10-21T00:00:00Z","timestamp":1477008000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Am J Health Promot"],"published-print":{"date-parts":[[2018,3]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose:<\/jats:title>\n                    <jats:p>To examine the effect of an opt-out default recruitment strategy compared to a conventional opt-in strategy on enrollment and adherence to a behavioral intervention for poorly controlled diabetic patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>Randomized controlled trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting:<\/jats:title>\n                    <jats:p>University of Pennsylvania primary care practices.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants:<\/jats:title>\n                    <jats:p>Participants of this trial included those with (1) age 18 to 80 years; (2) diabetes diagnosis; and (3) a measured hemoglobin A1c (HbA1c) greater than 8% in the past 12 months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention:<\/jats:title>\n                    <jats:p>We randomized eligible patients into opt-in and opt-out arms prior to enrollment. Those in the opt-out arm received a letter stating that they were enrolled into a diabetes research study with the option to opt out, and those in the opt-in arm received a standard recruitment letter.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Measures:<\/jats:title>\n                    <jats:p>Main end points include enrollment rate, defined as the proportion of participants who attended the baseline visit, and adherence to daily glycemic monitoring.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Analysis:<\/jats:title>\n                    <jats:p>We powered our study to detect a 20% difference in adherence to device usage between arms and account for a 10% attrition rate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Of the 569 eligible participants who received a recruitment letter, 496 were randomized to the opt-in arm and 73 to the opt-out arm. Enrollment rates were 38% in the opt-out arm and 13% in the opt-in arm ( P &lt; .001).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Opt-out defaults, where clinically appropriate, could be a useful approach for increasing the generalizability of low-risk trials testing behavioral interventions in clinical settings.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/0890117116671673","type":"journal-article","created":{"date-parts":[[2016,10,22]],"date-time":"2016-10-22T00:17:18Z","timestamp":1477095438000},"page":"745-752","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":30,"title":["A Randomized Controlled Trial of Opt-In Versus Opt-Out Enrollment Into a Diabetes Behavioral Intervention"],"prefix":"10.1177","volume":"32","author":[{"given":"Jaya","family":"Aysola","sequence":"first","affiliation":[{"name":"Division of General Internal Medicine, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA"},{"name":"Center for Health Incentives and Behavioral Economics (CHIBE) at the Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emin","family":"Tahirovic","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics (CCEB), University of Pennsylvania, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea B.","family":"Troxel","sequence":"additional","affiliation":[{"name":"Center for Health Incentives and Behavioral Economics (CHIBE) at the Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA"},{"name":"Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics (CCEB), University of Pennsylvania, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A.","family":"Asch","sequence":"additional","affiliation":[{"name":"Division of General Internal Medicine, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA"},{"name":"Center for Health Incentives and Behavioral Economics (CHIBE) at the Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA"},{"name":"Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, USA"},{"name":"Center for Health Equity Research and Promotion, Philadelphia VA Medical Center, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelsey","family":"Gangemi","sequence":"additional","affiliation":[{"name":"Center for Health Incentives and Behavioral Economics (CHIBE) at the Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda T.","family":"Hodlofski","sequence":"additional","affiliation":[{"name":"Center for Health Incentives and Behavioral Economics (CHIBE) at the Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingsan","family":"Zhu","sequence":"additional","affiliation":[{"name":"Center for Health Incentives and Behavioral Economics (CHIBE) at the Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Volpp","sequence":"additional","affiliation":[{"name":"Division of General Internal Medicine, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA"},{"name":"Center for Health Incentives and Behavioral Economics (CHIBE) at the Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA"},{"name":"Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, USA"},{"name":"Center for Health Equity Research and Promotion, Philadelphia VA Medical Center, Philadelphia, PA, USA"},{"name":"University of Pennsylvania Prevention Research Center, Philadelphia, PA, 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