Background: Cardiovascular disease is the leading cause of death in the United States; however, women and rural residents face notable health disparities compared with male and urban counterparts. Community-engaged programs hold promise to help address disparities through health behavior change and maintenance, the latter of which is critical to achieving clinical improvements and public health impact. Methods: A cluster-randomized controlled trial of Strong Hearts, Healthy Communities-2.0 conducted in medically underserved rural communities examined health outcomes and maintenance among women aged ≥40 years, who had a body mass index >30 or body mass index 25 to 30 and also sedentary. The multilevel intervention provided 24 weeks of twice-weekly classes with strength training, aerobic exercise, and skill-based nutrition education (individual and social levels), and civic engagement components related to healthy food and physical activity environments (community, environment, and policy levels). The primary outcome was change in weight; additional clinical and functional fitness measures were secondary outcomes. Mixed linear models were used to compare between-group changes at intervention end (24 weeks); subgroup analyses among women aged ≥60 years were also conducted. Following a 24-week no-contact period, data were collected among intervention participants only to evaluate maintenance. Results: Five communities were randomized to the intervention and 6 to the control (87 and 95 women, respectively). Significant improvements were observed for intervention versus controls in body weight (mean difference: −3.15 kg [95% CI, −4.98 to −1.32]; P =0.008) and several secondary clinical (eg, waist circumference: −3.02 cm [−5.31 to −0.73], P =0.010; systolic blood pressure: −6.64 mmHg [−12.67 to −0.62], P =0.031; percent body fat: −2.32% [−3.40 to −1.24]; P <0.001) and functional fitness outcomes; results were similar for women aged ≥60 years. The within-group analysis strongly suggests maintenance or further improvement in outcomes at 48 weeks. Conclusions: This cardiovascular disease prevention intervention demonstrated significant, clinically meaningful improvements and maintenance among rural, at-risk older women. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03059472.
Background Physical inactivity is a risk factor for numerous adverse health conditions and outcomes, including all-cause mortality. Aging rural women are at particular risk for physical inactivity based on environmental, sociocultural, and psychosocial factors. This study reports on changes in physical activity and associated factors from a multicomponent community-engaged intervention trial. Methods Strong Hearts, Healthy Communities 2.0 (SHHC-2.0) was a 24-week cluster (community) randomized controlled trial building on the results from the previous trial of SHHC-1.0. Rural women (n = 182) aged 40 and over living in 11 rural communities in upstate New York were recruited. The intervention consisted of twice-weekly experiential classes focused on exercise, nutrition, and civic engagement. Physical activity outcomes included accelerometry and self-report as well as related psychosocial measures at midpoint (12 weeks) and post-intervention (24 weeks). Data were analyzed using multilevel linear regression models with the community as the random effect. Results Compared to participants from the control communities, participants in the intervention communities showed a significant increase in objectively measured moderate to vigorous intensity physical activity: at 12 weeks (increase of 8.1 min per day, P < 0.001) and at 24 weeks (increase of 6.4 min per day; P = 0.011). Self-reported total MET minutes per week also increased: at 12 weeks (increase of 725.8, P = 0.003) and 24 weeks (increase of 955.9, P = 0.002). Several of the psychosocial variables also showed significant positive changes. Conclusions The SHHC-2.0 intervention successfully increased physical activity level and related outcome measures. Modifications made based upon in-depth process evaluation from SHHC-1.0 appear to have been effective in increasing physical activity in this at-risk population. Trial registration Clinicaltrials.gov: NCT03059472. Registered 23 February 2017.
Little is known about pandemic-related impacts on participant recruitment into community-based health studies during the COVID-19 pandemic. The aim of this report was to summarize lessons learned from principal investigators (PIs) of NIH-funded community-based health behavior studies that were scheduled to recruit during the COVID-19 pandemic. We report on findings from three open-ended questions that were part of a 50-question online survey conducted from December 2022 – January 2023, completed by 52 PIs. Four categories of lessons emerged to optimize recruitment into studies: formalize relationships with community partnerships; focus on study operations; recruitment is a science and an art; and reduce participant burden and increase participant benefit. Taken together, these recommendations will require longer and more complex recruitment plans. To implement these plans, researchers and funders will need to allocate more time, thoughtful attention, and financial resources to support formal community partnerships, additional staff time and training, real-time monitoring and refinement of multiple strategies throughout recruitment, and increased attention to participant benefit.
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