Testing the effectiveness of community-engaged citizen science to promote physical activity, foster healthier neighborhood environments, and advance health equity in vulnerable communities: The Steps for Change randomized controlled trial design and methods.

While low-income midlife and older adults are disproportionately affected by non-communicable diseases that can be alleviated by regular physical activity, few physical activity programs have been developed specifically with their needs in mind. Those programs that are available typically do not address the recognized local environmental factors that can impact physical activity. The specific aim of the Steps for Change cluster-randomized controlled trial is to compare systematically the initial (one-year) and sustained (two-year) multi-level impacts of an evidence-based person-level physical activity intervention (Active Living Every Day [ALED] and age-relevant health education information), versus the ALED program in combination with a novel neighborhood-level citizen science intervention called Our Voice. The study sample (N = 300) consists of insufficiently active adults ages 40 years and over living in or around affordable senior public housing settings. Major study assessments occur at baseline, 12, and 24 months. The primary outcome is 12-month change in walking, and secondary outcomes include other forms of physical activity, assessed via validated self-report measures supported by accelerometry, and physical function and well-being variables. Additional intervention impacts are assessed at 24 months. Potential mediators and moderators of intervention success will be explored to better determine which subgroups do best with which type of intervention. Here we present the study design and methods, including recruitment strategies and yields. TRIAL REGISTRATION: clinicaltrial.gov Identifier = NCT03041415.

Effects of Counseling by Peer Human Advisors vs Computers to Increase Walking in Underserved Populations: The COMPASS Randomized Clinical Trial.

Importance: Effective and practical treatments are needed to increase physical activity among those at heightened risk from inactivity. Walking represents a popular physical activity that can produce a range of desirable health effects, particularly as people age. Objective: To test the hypothesis that counseling by a computer-based virtual advisor is no worse than (ie, noninferior to) counseling by trained human advisors for increasing 12-month walking levels among inactive adults. Design, Setting, and Participants: A cluster-randomized, noninferiority parallel trial enrolled 245 adults between July 21, 2014, and July 29, 2016, with follow-up through September 15, 2017. Data analysis was performed from March 15 to December 20, 2018. The evidence-derived noninferiority margin was 30 minutes of walking per week. Participants included inactive adults aged 50 years and older, primarily of Latin American descent and capable of walking without significant limitations, from 10 community centers in Santa Clara and San Mateo counties, California. Interventions: All participants received similar evidence-based, 12-month physical activity counseling at their local community center, with the 10 centers randomized to a computerized virtual advisor program (virtual) or a previously validated peer advisor program (human). Main Outcomes and Measures: The primary outcome was change in walking minutes per week over 12 months using validated interview assessment corroborated with accelerometry. Both per-protocol and intention-to-treat analysis was performed. Results: Among the 245 participants randomized, 193 were women (78.8%) and 241 participants (98.4%) were Latino. Mean (SD) age was 62.3 (8.4) years (range, 50-87 years), 107 individuals (43.7%) had high school or less educational level, mean BMI was 32.8 (6.8), and mean years residence in the US was 47.4 (17.0) years. A total of 231 participants (94.3%) completed the study. Mean 12-month change in walking was 153.9 min/wk (95% CI, 126.3 min/wk to infinity) for the virtual cohort (n = 123) and 131.9 min/wk (95% CI, 101.4 min/wk to infinity) for the human cohort (n = 122) (difference, 22.0, with lower limit of 1-sided 95% CI, -20.6 to infinity; P = .02); this finding supports noninferiority. Improvements emerged in both arms for relevant clinical risk factors, sedentary behavior, and well-being measures. Conclusions and Relevance: The findings of this study indicate that a virtual advisor using evidence-based strategies produces significant 12-month walking increases for older, lower-income Latino adults that are no worse than the significant improvements achieved by human advisors. Changes produced by both programs are commensurate with those reported in previous investigations of these behavioral interventions and provide support for broadening the range of light-touch physical activity programs that can be offered to a diverse population. Trial Registration: ClinicalTrials.gov Identifier: NCT02111213.

Testing the comparative effects of physical activity advice by humans vs. computers in underserved populations: The COMPASS trial design, methods, and baseline characteristics.

While physical inactivity is a key risk factor for a range of chronic diseases and conditions associated with aging, a significant proportion of midlife and older adults remain insufficiently active. This is particularly true for ethnic minority populations such as Latino adults for whom few culturally adapted programs have been developed and tested. The major objective of this 12-month cluster-randomized controlled trial is to test the comparative effectiveness of two linguistically and culturally adapted, community-based physical activity interventions with the potential for broad reach and translation. Ten local community centers serving a sizable number of Latino residents were randomized to receive one of two physical activity interventions. The Virtual Advisor program employs a computer-based embodied conversational agent named "Carmen" to deliver interactive, individually tailored physical activity advice and support. A similar intervention program is delivered by trained Peer Advisors. The target population consists of generally healthy, insufficiently active Latino adults ages 50years and older living within proximity to a designated community center. The major outcomes are changes in walking and other forms of physical activity measured via self-report and accelerometry. Secondary outcomes include physical function and well-being variables. In addition to these outcome analyses, comparative cost analysis of the two programs, potential mediators of intervention success, and baseline moderators of intervention effects will be explored to better determine which subgroups do best with which type of intervention. Here we present the study design and methods, including recruitment strategies and yield as well as study baseline characteristics. TRIAL REGISTRATION: clinicaltrial.gov Identifier=NCT02111213.