Abstract

Background/Objectives: This pilot randomized controlled trial aimed to help people with metabolic syndrome increase physical activity and well-being. Intervening on lifestyle behaviors such as physical activity, can improve metabolic syndrome outcomes. Methods: Primary care patients with metabolic syndrome were recruited from clinics across our hospital system. Eligibility criteria were: <150 minutes/week of moderate-vigorous physical activity (MVPA), having ≥2 of 5 metabolic syndrome criteria, and not having cardiovascular disease or diabetes, as this was a prevention study. The multilevel intervention (MAPP) included 8-weekly 60-minute group sessions, physical activity self-monitoring/goal setting using Fitbits, physical activity/motivational interviewing (MI) topics, positive psychology (PP) topics, a weekly group walk prior to COVID, and neighborhood walkability assessments. Participants were randomized to an immediate or waitlist control group. They wore an Actigraph GT3X+ accelerometer for one week before beginning and after the last session (8-weeks). We obtained pre-post weight measurements. Mean baseline to 8-week individual difference results were compared between groups using t-tests with unequal variances. Results: Sixty-four participants enrolled, with 32 randomized to each arm; 51 provided complete follow-up data, and 63% (10/16) of the groups were conducted virtually (post-COVID). Most (92%; 59/64) were non-Hispanic White, 69% (44/64) were female, and mean age was 60. Average daily physical activity did not increase significantly by objective measures. The estimated change in mean difference for sedentary time decreased for the intervention group compared to the control group by 46.8 minutes/day (CI: -47.5-141.1; d= 0.28). Light physical activity increased by an average of 21.0 minutes/day (CI: -13.9-55.9; d= 0.34), steps/day increased by 376.6 (CI: -949.6-1702.9; d =0.16), and moderate-vigorous physical activity increased by 4.1 minutes/day (CI: -4.5-12.8; d=0.27). The estimated change in mean weight was significant: 8.4 pounds lost for the intervention group compared to the control group (CI: -13.5-3.2; p =.002; d =0.92). Discussion: This 8-week randomized controlled trial of a multilevel physical activity PP-MI intervention was associated with small to medium effect sizes for changes in physical activity, and a significant decrease in weight, despite weight not being an intervention target. Changes of this magnitude are associated with reduced cardiovascular disease risk and mortality. These findings are all in expected directions, producing signals even amidst different modalities and COVID-19-related disruptions. We plan to test this in a larger efficacy trial with broader reach and implementation.

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