Community Walks: a cluster randomized controlled trial of a multilevel physical activity intervention for low income public housing residents.

BACKGROUND: Physical activity behavioral interventions to change individual-level drivers of activity, like motivation, attitudes, and self-efficacy, are often not sustained beyond the intervention period. Interventions at both environmental and individual levels might facilitate durable change. This community-based study seeks to test a multilevel, multicomponent intervention to increase moderate intensity physical activity among people with low incomes living in U.S. public housing developments, over a 2 year period. METHODS: The study design is a prospective, cluster randomized controlled trial, with housing developments (n=12) as the units of randomization. In a four-group, factorial trial, we will compare an environmental intervention (E) alone (3 developments), an individual intervention (I) alone (3 developments), an environmental plus individual (E+I) intervention (3 developments), against an assessment only control group (3 developments). The environmental only intervention consists of community health workers leading walking groups and indoor activities, a walking advocacy program for residents, and provision of walking maps/signage. The individual only intervention consists of a 12-week automated telephone program to increase physical activity motivation and self-efficacy. All residents are invited to participate in the intervention activities being delivered at their development. The primary outcome is change in moderate intensity physical activity measured via an accelerometer-based device among an evaluation cohort (n=50 individuals at each of the 12 developments) from baseline to 24-month follow up. Mediation (e.g., neighborhood walkability, motivation) and moderation (e.g., neighborhood stress) of our interventions will be assessed. Lastly, we will interview key informants to assess factors from the Consolidated Framework for Implementation Research domains to inform future implementation. DISCUSSION: We hypothesize participants living in developments in any of the three intervention groups (E only, I only, and E+I combined) will increase minutes of moderate intensity physical activity more than participants in control group developments. We expect delivery of an intervention package targeting environmental and social factors to become active, combined with the individual level intervention, will improve overall physical activity levels to recommended guidelines at the development level. If effective, this trial has the potential for implementation through other federal and state housing authorities. TRIAL REGISTRATION: Clinical Trails.gov PRS Protocol Registration and Results System, NCT05147298 . Registered 28 November 2021.

Randomized controlled trial of MyLastDip: a Web-based smokeless tobacco cessation program for chewers ages 14-25.

INTRODUCTION: Use of smokeless tobacco (ST) is a significant public health problem for young adults, many of whom want to quit. We describe the outcome of a Randomized Controlled Trial (RCT) examining the efficacy of two web-based ST cessation interventions targeting young chewers. METHODS: One thousand seven hundred and sixteen ST users wanting to quit were recruited online to the MyLastDip program and randomly assigned to one of two fully automated web-based ST cessation interventions: (a) an Enhanced Condition (N = 857) with tailored treatment recommendations and interactive features, or (b) a Basic Condition (N = 859) that provided an online ST cessation guide in static text. RESULTS: Assessment completion rates at 3 months, 6 months, and for both 3 and 6 months were 73%, 71%, and 65%, respectively. No significant differences were found between conditions. Using complete case analysis for repeated point prevalence (3- and 6-month assessments), all tobacco abstinence was 28.9% for participants in the Enhanced Condition and 25.6% in the Basic Condition. Using intent-to-treat analysis, abstinence rates were 35.2% versus 32.3%. Similar results were obtained for ST abstinence. Participants reported being satisfied with their programs and the Enhanced Condition participants were relatively more engaged. Differences in program engagement were not related to tobacco abstinence at 6 months. CONCLUSIONS: Both web-based ST cessation programs encouraged robust levels of absolute tobacco and ST abstinence at follow-up. The absence of between-group differences was discussed in terms of composition of the control condition and implications for next steps in treatment development and testing.