Trial reportInternational journal of behavioral medicine2025
Patient Preferences for Lifestyle Management in a Multi-site Randomized Lifestyle Trial for Remission of the Metabolic Syndrome.
Trial report in International journal of behavioral medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
4 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundRandomized behavioral clinical trials are the gold standard for evaluating efficacy of a behavioral treatment. However, because participants are generally unblinded to treatment, preference for a specific treatment option can lead to biased results and/or reduced treatment efficacy. The purpose was to describe the relative frequency and correlates of existence of a preference and patient preference for either an in-person group-based or a remote self-directed, lifestyle treatment prior to randomization to one of these treatments.
methodsThe Enhanced Lifestyles for Metabolic Syndrome (ELM) trial is a multi-site behavioral clinical trial that compares efficacy of a group-based vs. a self-directed approach to lifestyle change on 2-year remission of the metabolic syndrome. Prior to randomization, participants were asked whether they had a preference for a particular treatment and, if so, which approach they preferred. Baseline data were used for a series of logistic regression models to determine behavioral correlates of treatment preference, independent of socioeconomic factors.
resultsOf the 331 participants, 131 (39.6%) had no preference for either treatment. Among the 200 with a preference, 56 (28.0%) preferred the self-directed program. Strength of a pre-existing habit of eating vegetables on most days was an independent correlate of no preference (adjusted OR, 1.27; 95% CI, 1.01-1.61; p = 0.03) and preference for a self-directed program (adjusted OR, 1.55; 95% CI, 1.09-2.22; p = 0.01).
conclusionA pre-existing habit of eating vegetables was associated with no preference and preference for a less intensive lifestyle treatment. Post-treatment follow-up of the trial results will determine if concordance between preference and treatment assignment influences outcomes.
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