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Background Rural United States communities often experience disproportionate burdens of obesity, cardiovascular disease, diabetes, and premature mortality. Built environment constraints, including limited sidewalks, recreation facilities, and access to nutritious foods, may restrict opportunities for adoption and maintenance of healthy eating and physical activity behaviors. Civic engagement approaches empower residents to assess community needs, develop action plans, and implement policy, systems, and environmental (PSE) strategies. However, few randomized trials have examined implementation of PSE strategies and their impacts in rural adult populations. This study evaluated implementation of Cooperative Extension-led Change Club (CC) community project action plans aimed at facilitating PSE change in six rural and micropolitan Texas and New York intervention communities. Presently, we document implementation outcomes and identify factors that may have influenced implementation using the Consolidated Framework for Implementation Research (CFIR). Methods CCs followed a 24-module curriculum facilitated by trained Extension educators. Approved action plans were provided with seed money to target diet and physical activity PSE changes. Implementation outcomes regarding the action plans were tracked through educator reports, interviews, and proposals. CFIR factors were assessed during the early stages of action plan implementation using interviews with educators and participant residents. Results All six intervention communities implemented action plans, most of which had multiple components. Each prioritized environmental changes and most focused on addressing physical activity. Implementation timing and continuity varied, influenced by external factors such as weather and local approvals. CFIR analysis identified beliefs about feasibility, stakeholder engagement, and group decision-making as key factors influencing implementation. Conclusions Rural CCs successfully launched a variety of built environment initiatives. This implementation evaluation highlights pathways and barriers related to scaling rural civic engagement strategies. Trial registration Clinical Trial #NCT05002660 (August 2021).

Background Strong Hearts, Healthy Communities 2.0 (SHHC-2.0) was a 24-week cardiovascular disease prevention program that was effective in improving physical activity and nutrition behaviors and clinical outcomes among women in 11 rural New York, USA towns. This study evaluated the delivery of SHHC-2.0 to prepare the intervention for further dissemination. Methods This process evaluation was guided by the Medical Research Council recommendations and engaged program leaders and participants (i.e., women over age 40) using quantitative and qualitative methods. The quantitative evaluation included examination of enrollment and retention data, a participant survey, and a fidelity checklist completed after classes. Descriptive and comparative statistics were used to assess implementation measures: program reach, participant attendance, dose delivered, program length, perceived effectiveness, fidelity, and participant satisfaction. The qualitative evaluation included focus groups ( n  = 13) and interviews ( n  = 4) using semi-structured guides; audio was recorded and transcripts were deductively coded and analyzed using directed content analysis and iterative categorization approaches. Comparisons across towns and between intervention and waitlist control groups were explored. Results Average reach within towns was 7.5% of the eligible population (range 0.7-15.7%). Average attendance was 59.8% of sessions (range 42.0-77.4%). Average dose delivered by leaders was 86.4% of curriculum components (range 73.5-95.2%). Average session length was 51.8 ± 4.8 min across 48 sessions. Leaders’ perceived effectiveness rating averaged 4.1 ± 0.3 out of 5. Fidelity to curricular components was 81.8% (range 67.4-93.2%). Participants reported being “more than satisfied” with the overall program (88.8%) and the health benefits they obtained (72.9%). Qualitative analysis revealed that participants: (1) gained new knowledge and enjoyable experiences; (2) perceived improvements in their physical activity, nutrition, and/or health; (3) continued to face some barriers to physical activity and healthy eating, with those relating to social support being reduced; and (4) rated leaders and the group structure highly, with mixed opinions on the research elements. Conclusions SHHC-2.0 had broad reach, was largely delivered as intended, and participants expressed high levels of satisfaction with the program and its health benefits. Our findings expand on best practices for implementing cardiovascular disease prevention programs in rural communities. Clinical trials Registration www.clinicaltrials.gov #NCT03059472.

Background Prior studies demonstrate associations between risk factors for obesity and related chronic diseases (e.g., cardiovascular disease) and features of the built environment. This is particularly true for rural populations, who have higher rates of obesity, cancer, and other chronic diseases than urban residents. There is also evidence linking health behaviors and outcomes to social factors such as social support, opposition, and norms. Thus, overlapping social networks that have a high degree of social capital and community cohesion, such as those found in rural communities, may be effective targets for introducing and maintaining healthy behaviors. Methods This study will evaluate the effectiveness of the Change Club (CC) intervention, a civic engagement intervention for built environment change to improve health behaviors and outcomes for residents of rural communities. The CC intervention provides small groups of community residents (approximately 10–14 people) with nutrition and physical activity lessons and stepwise built environment change planning workshops delivered by trained extension educators via in-person, virtual, or hybrid methods. We will conduct process, multilevel outcome, and cost evaluations of implementation of the CC intervention in a cluster randomized controlled trial in 10 communities across two states using a two-arm parallel design. Change in the primary outcome, American Heart Association’s Life’s Simple 7 composite cardiovascular health score, will be evaluated among CC members, their friends and family members, and other community residents and compared to comparable samples in control communities. We will also evaluate changes at the social/collective level (e.g., social cohesion, social trust) and examine costs as well as barriers and facilitators to implementation. Discussion Our central hypothesis is the CC intervention will improve health behaviors and outcomes among engaged citizens and their family and friends within 24 months. Furthermore, we hypothesize that positive changes will catalyze critical steps in the pathway to improving longer-term health among community residents through improved healthy eating and physical activity opportunities. This study also represents a unique opportunity to evaluate process and cost-related data, which will provide key insights into the viability of this approach for widespread dissemination. Trial registration ClinicalTrials.gov: NCT05002660 , Registered 12 August 2021.

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.

Background Women living in rural areas face unique challenges in achieving a heart-healthy lifestyle that are related to multiple levels of the social-ecological framework. The purpose of this study was to evaluate changes in diet and physical activity, which are secondary outcomes of a community-based, multilevel cardiovascular disease risk reduction intervention designed for women in rural communities. Methods Strong Hearts, Healthy Communities was a six-month, community-randomized trial conducted in 16 rural towns in Montana and New York, USA. Sedentary women aged 40 and older with overweight and obesity were recruited. Intervention participants (eight towns) attended twice weekly exercise and nutrition classes for 24 weeks (48 total). Individual-level components included aerobic exercise, progressive strength training, and healthy eating practices; a civic engagement component was designed to address social and built environment factors to support healthy lifestyles. The control group (eight towns) attended didactic healthy lifestyle classes monthly (six total). Dietary and physical activity data were collected at baseline and post-intervention. Dietary data were collected using automated self-administered 24-h dietary recalls, and physical activity data were collected by accelerometry and self-report. Data were analyzed using multilevel linear regression models with town as a random effect. Results At baseline, both groups fell short of meeting many recommendations for cardiovascular health. Compared to the control group, the intervention group realized significant improvements in intake of fruit and vegetables combined (difference: 0.6 cup equivalents per day, 95% CI 0.1 to 1.1, p  = .026) and in vegetables alone (difference: 0.3 cup equivalents per day, 95% CI 0.1 to 0.6, p  = .016). For physical activity, there were no statistically significant between-group differences based on accelerometry. By self-report, the intervention group experienced a greater increase in walking MET minutes per week (difference: 113.5 MET-minutes per week, 95% CI 12.8 to 214.2, p  = .027). Conclusions Between-group differences in dietary and physical activity behaviors measured in this study were minimal. Future studies should consider how to bolster behavioral outcomes in rural settings and may also continue to explore the value of components designed to enact social and environmental change. Trial registration clinicaltrials.gov Identifier: NCT02499731. Registered 16 July 2015.

This study examined whether civic engagement (CE) and social connectedness (SC) differ by sociodemographic characteristics and social determinants of health (SDOH). Baseline data were drawn from a rural community-randomized controlled trial (n = 2381). Sociodemographic characteristics included sex, age, race/ethnicity, marital status, education, employment, and income. SDOH measures included food insecurity, having a regular healthcare provider, housing instability, utility shutoffs, transportation access, and government assistance. CE measures included attitudes, behaviors, and mobilization, while SC measures included community health investment, social cohesion, and social networks. Bivariate associations were estimated using linear regression to assess relationships between CE and SC measures and sociodemographic and SDOH measures. Being married, college-educated, or employed were positively associated with multiple CE measures. SC measures were consistently higher among participants with greater educational attainment and lower among those experiencing food insecurity. Findings highlight persistent inequities in CE and SC across sociodemographic and SDOH factors within rural communities.

Rural communities are at higher risk for physical inactivity, poor dietary behaviors, and related chronic diseases and obesity. These disparities are largely driven by built environment, socioeconomic, and social factors. A community-based cluster randomized controlled trial of an intervention, the Change Club, aims to address some of these disparities via civic engagement for built environment change. Baseline data collection began in February 2020, only to be paused by the COVID-19 pandemic. In this context, the investigators evaluated multiple approaches for collecting data when the study resumed, focusing on Life’s Simple 7, and additional anthropometric, physiologic, and behavioral outcomes in rural and micropolitan (<50,000 population) communities in Texas and New York. Life’s Simple 7 includes fasting blood glucose, total cholesterol, blood pressure, weight, physical activity, diet, and smoking. Rigor and feasibility were considered across a variety of in-person versus at-home measurement options. After a comprehensive input from participants, partners, staff, researchers, and the funding liaison, the study team chose self-measurement and use of validated questionnaires/surveys to measure the Life’s Simple 7 components. This case provides an example of how a study team might adjust data collection protocol during unexpected and acute events while giving consideration to rigor, feasibility, stakeholder views, and participants’ health and safety.

Rural populations have worse health outcomes than urban populations. Community-based health interventions can help to improve these outcomes, but rural populations are underrepresented in research. The goals of the study were to describe and examine the effectiveness and cost-effectiveness of strategies to recruit into a rural, community-based health intervention study. The Change Club study is a community-based health intervention conducted in medically underserved rural communities in Texas and New York to assess whether a civic engagement program improves health among intervention participants and their communities. The study was promoted online, via mailings, email, educators, flyers/posters, and traditional media, and encouraged referrals from friends and family members. For each recruitment strategy, the resulting number of enrolled participants and costs were compiled. The most effective recruitment strategy was letters, which contributed 37.7% of participants, followed by friends/family (23.2%), postcards (22.3%), social media advertisements (13.3%), and flyers/posters (8.4%). The overall cost per enrolled participant was 12.36). The least cost-effective strategy was local educators' phone calls and texts, which cost $6,803 and yielded no enrollments. Mailing of recruitment letters, word-of-mouth referrals from family and friends, advertisements on social media, and the distribution and posting of flyers/posters were effective and cost-effective strategies and we recommend them for future studies in similar locations. Leveraging the close-knit social ties in rural communities to recommend study participation may be particularly fruitful, but researchers should investigate potential selection bias. Clinicaltrials.gov, NCT05002660 Registered on 04 August 2021.

Background/Objectives: Multilevel interventions have demonstrated efficacy in improving obesity and other related health outcomes. However, heterogeneity in individual responses indicates the need to identify the factors associated with responses and non-responses to multilevel interventions. The objective of this report is to identify the potential sources of heterogeneity through the exploration of the moderation effects of participant characteristics (sociodemographic and baseline physical/mental health) in the Strong Hearts, Healthy Communities-2.0 (SHHC-2.0) intervention. Methods: SHHC-2.0 is a 24-week multilevel intervention to improve people’s diet and physical activity evaluated using a cluster-randomized, controlled trial design conducted with women aged 40 and older living in rural communities with an elevated risk of cardiovascular disease, defined as having a BMI > 30, or a BMI 25–30 plus < 1 weekly occurrence of 30 min of physical activity during leisure time. Linear mixed models were used to compare the between-group changes in the outcomes (weight, systolic blood pressure, hemoglobin A1c [HbA1c], and triglycerides), with an interaction term included for each potential moderator. Results: Within the sociodemographic characteristics, there were no differences in effectiveness by age, income, or baseline BMI status, however the participants with a high school education or less experienced greater weight loss. Among their health history, only a history of hypertension was associated with differential outcomes; those with a history of hypertension demonstrated a greater reduction in systolic blood pressure. The participants with elevated depressive symptoms demonstrated greater weight loss and a greater reduction in the HbA1c level. Conclusions: SHHC-2.0 was effective across a wide range of participants. The identified moderators (i.e., education level) may inform the future tailoring of the SHHC intervention to optimize the outcomes among participant subgroups, while more broadly, our findings can serve to inform the development and dissemination of multilevel interventions.

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