Changes in physical activity outcomes in the Strong Hearts, Healthy Communities (SHHC-2.0) community-based randomized trial.

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.

Evaluation of a civic engagement approach to catalyze built environment change and promote healthy eating and physical activity among rural residents: a cluster (community) randomized controlled trial.

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.

Changes in diet and physical activity resulting from the Strong Hearts, Healthy Communities randomized cardiovascular disease risk reduction multilevel intervention trial.

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.

COVID-19 Related Protocol Considerations and Modifications within a Rural, Community-Engaged Health Promotion Randomized Trial.

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.

Improvements and Maintenance of Clinical and Functional Measures Among Rural Women: Strong Hearts, Healthy Communities-2. 0 Cluster Randomized Trial.

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.

The Strong Hearts, Healthy Communities Program 2.0: An RCT Examining Effects on Simple 7.

INTRODUCTION: Rural women have higher rates of cardiovascular disease than their nonrural counterparts, partially because of their social and environmental contexts. The study objective is to test a refined version of the multilevel Strong Hearts, Healthy Communities intervention, which used extensive process and outcome evaluation data from the original randomized trial to optimize effectiveness as measured by improved Simple 7 score, a composite measure of cardiovascular disease risk. STUDY DESIGN: The intervention was implemented in a 6-month, delayed intervention, community-randomized trial; control participants received the program following 24-week outcome assessment. The study was conducted in 2017-2018; data analysis occurred in 2018-2019. SETTING/PARTICIPANTS: The study was conducted in 11 rural, medically underserved towns in New York. Participants were women aged ≥40 years who were either (1) obese or (2) overweight and sedentary. INTERVENTION: The intervention group received 24 weeks of hour-long, twice-weekly classes including strength training, aerobic exercise, and skill-based nutrition- and health-related education, as well as civic engagement activities focused on healthy food and physical activity environments. MAIN OUTCOME MEASURES: Measures included weight and height; blood pressure; blood cholesterol; blood glucose; and self-reported smoking, diet, and physical activity behaviors. Individual Simple 7 components were examined, and mixed linear regression analyses were used to examine change in Simple 7 score. RESULTS: A total of 182 participants were randomized. Compared with control participants, the intervention group had greater improvements in Simple 7 score (difference=1.03, 95% CI=0.44, 1.61, p<0.001) and 3 of the Simple 7 components (physical activity, healthy diet score, and BMI). CONCLUSIONS: These findings highlight the importance of rigorously evaluating programs in real-world community settings and, when appropriate, revising and retesting interventions to optimize dissemination potential. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT03059472.