Multilevel Interventions Targeting Obesity: State of the Science and Future Directions.

A seminal report, released in 2001 by the Institute of Medicine, spurred research on the design, implementation, and evaluation of multilevel interventions targeting obesity and related behaviors. By addressing social and environmental factors that support positive health behavior change, interventions that include multiple levels of influence (e.g., individual, social, structural) aim to bolster effectiveness and, ultimately, public health impact. With more than 20 years of multilevel obesity intervention research to draw from, this review was informed by published reviews (n = 51) and identified intervention trials (n = 103), inclusive of all ages and countries, to elucidate key learnings about the state of the science. This review provides a critical appraisal of the scientific literature related to multilevel obesity interventions and includes a description of their effectiveness on adiposity outcomes and prominent characteristics (e.g., population, setting, levels). Key objectives for future research are recommended to advance innovations to improve population health and reduce obesity.

Improvements in dietary intake, behaviors, and psychosocial measures in a community-randomized cardiovascular disease risk reduction intervention: Strong Hearts, Healthy Communities 2.0.

BACKGROUND: Cardiovascular disease (CVD) prevalence has disproportionately risen among midlife and older female adults of rural communities, partly due to poor diet and diet-related behaviors and psychosocial factors that impede healthy eating. OBJECTIVES: This study aimed to evaluate the impact of Strong Hearts Healthy Communities 2.0 (SHHC-2.0) on secondary diet-related outcomes between intervention and control participants that align with the dietary goal and behavioral aims of the SHHC-2.0, a CVD risk reduction program. METHODS: A community-randomized controlled trial was conducted in rural, medically underserved communities. Participants were female adults ≥40 y who were classified as obese or both overweight and sedentary. Communities were randomized to SHHC-2.0 intervention (n = 5 communities; n = 87 participants) or control (with delayed intervention) (n = 6 communities; n = 95 participants). SHHC-2.0 consisted of 24 wk of twice-weekly experiential nutrition education and group-based physical activity classes led by local health educators. Changes between baseline and end point (24 wk) in dietary intake (24-h recalls), dietary behaviors (e.g., Rapid Eating Assessment for Participants-Short Version [REAP-S] scores) and diet-related psychosocial measures (e.g., Three Factor Eating questionnaire) between groups were analyzed using linear mixed-effects multilevel models. RESULTS: At 24 wk, participants from the 5 intervention communities, compared with controls, consumed fewer calories (mean difference [MD]= -211 kcal, 95% CI: -412, -110, P = 0.039), improved overall dietary patterns measured by REAP-S scores (MD: 3.9; 95% CI: 2.26, 5.6; P < 0.001), and improved psychosocial measures (healthy eating attitudes, uncontrolled eating, cognitive restraint, and emotional eating). CONCLUSIONS: SHHC-2.0 has strong potential to improve diet patterns and diet-related psychosocial wellbeing consistent with improved cardiovascular health. This trial was registered at www. CLINICALTRIALS: gov as NCT03059472.

Recruiting experiences of NIH-funded principal investigators for community-based health behavior interventions during the COVID-19 pandemic.

Successful recruitment into randomized trials and interventions is essential to advance scientific knowledge to improve health. This rapid assessment study explored how the COVID-19 pandemic affected participant recruitment overall, identified how it exacerbated existing challenges to recruit hard-to-reach populations, and described how NIH-funded Principal Investigators (PIs) responded to COVID-era recruitment challenges. A cross-sectional survey of NIH-funded PIs conducting interventions and trials related to health behaviors was conducted in 2022. The survey was completed by 52 PIs, most of whom were highly experienced in this type of research. Eighteen PIs reported it was very difficult to recruit participants now (39.1%) compared to before COVID-19 when only one did (2.2%). PIs reported changing recruitment and data collection methods (29.4%), increasing staff dedicated to recruitment (29.4%), and increasing participant compensation (23.5%). Recruitment methods shifted from in-person activities to social media and other electronic communications. Barriers to recruitment included reluctance to participate in research, COVID-19 protocols and precautions, overwhelmed community partners, staff burnout and turnover, and limited access to technology for some populations that were already hard to reach. Facilitators to recruitment consisted of increased access and ability to use remote technologies, use of social media, strong community ties, and wanting to be part of something positive. PIs perceived recruitment as much more difficult after the onset of COVID-19, though research teams were able to pivot to more online and remote options. These tools may have a lasting impact in modernizing recruitment, data collection, and intervention techniques in future trials.

Integrating Civic Engagement Into a Lifestyle Intervention for Rural Women - A Mixed Methods Process Evaluation.

PURPOSE: The present study aimed to evaluate the implementation of a civic engagement curriculum (HEART Club) designed to catalyze positive environmental change in rural communities. DESIGN: The HEART Club curriculum was integrated into a six-month community-based health behavior intervention to reduce cardiovascular disease risk. SETTING: Participants were recruited from eight rural towns in Montana and New York. SUBJECTS: 101 midlife and older women. INTERVENTION: Participants worked to address an issue related to their local food or physical activity environment and establish progress monitoring benchmarks. METHOD: Evaluation components included after-class surveys, program leader interviews (n = 15), participant focus groups (n = 8), and post-intervention surveys. RESULTS: Intervention sites reported high fidelity (78%) to the curriculum. Average attendance was 69% and program classes were rated as highly effective (4.1 out of 5). Despite positive participant feedback, low readiness for civic engagement and insufficient time were implementation challenges. The majority of HEART Club groups had accomplished two or more benchmarks post-intervention. Facilitators of progress included community support, effective leadership, and collective effort. Participants also indicated that trying to affect community change while simultaneously making personal health improvements likely stalled initial progress. CONCLUSION: These findings highlight the potential and challenges associated with civic engagement within the context of rural lifestyle interventions. Future implementation efforts should focus on reframing civic engagement as an approach to support and maintain behavior change.

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.

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.

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.

Physical activity and healthy eating behavior changes among rural women: an exploratory mediation analysis of a randomized multilevel intervention trial.

Rural women experience disproportionately higher levels of obesity in comparison to their non-rural counterparts. The present exploratory mediation analysis sought to identify mechanisms that might have contributed to rural women's physical activity and diet changes after participating in a 6-month multilevel community-randomized trial: Strong Hearts, Healthy Communities (SHHC). SHHC was conducted in 16 rural towns in Montana and New York, between 2015 and 2016; 194 overweight, sedentary midlife, and older women (mean age 59; 26.8% overweight; 73.2% obese) participated. Participants in eight towns received the SHHC intervention (n = 101), which focused on healthy behavior change at the individual level as well as creating supportive social and built environments for physical activity and healthy eating. Participants in the other eight towns received an education-only control intervention (n = 93). We investigated the direct and indirect effects of the SHHC intervention through changes to self-efficacy, social support, and built environment perception, on changes in participants' physical activity and diet. Compared to the controls, SHHC intervention participants increased their social support from friends for physical activity (p = 0.009) and healthy eating (p = 0.032). Participants' improved social support from friends marginally mediated the intervention effects for walking metabolic equivalent minutes per week, explaining 40.5% of the total effect (indirect effect = +45.24, 95% CI: -1.51, +91.99; p = 0.059). Increasing social support from friends appears to be helpful in encouraging rural women to become more active. Further investigations are needed to better understand how multilevel interventions work in rural communities.

Feasibility of a yoga intervention to decrease pain in older women: a randomized controlled pilot study.

BACKGROUND: A significant proportion of older women suffer from chronic pain, which can decrease quality of life. The objective of this pilot randomized study was to evaluate the feasibility of a flow-restorative yoga intervention designed to decrease pain and related outcomes among women aged 60 or older. METHODS: Flow-restorative yoga classes were held twice weekly for 1 hour and led by a certified yoga instructor. Participants randomized to the intervention group attended the yoga classes for 12 weeks and received supplemental materials for at-home practice. Those randomized to the control group were asked to maintain their normal daily routine. Feasibility was evaluated using recruitment and retention rates, class and home practice adherence rates, and participant satisfaction surveys. Outcome measures (self-reported pain, inflammatory markers, functional fitness, quality of life, resilience, and self-reported physical activity) were assessed at baseline and post-intervention. Paired t-tests or Wilcoxon signed-rank tests were used to examine changes in outcome measures within treatment groups. RESULTS: Thirty-eight participants were recruited and randomized. Participants were primarily white, college-educated, and higher functioning, despite experiencing various forms of chronic pain. Attendance and retention rates were high (91 and 97%, respectively) and the majority of participants were satisfied with the yoga program (89%) and would recommend it to others (87%). Intervention participants also experienced reductions in pain interference and improvements in energy and social functioning. CONCLUSIONS: This pilot study provides essential data to inform a full scale randomized trial of flow-restorative yoga for older women with chronic pain. Future studies should emphasize strategies to recruit a more diverse study population, particularly older women at higher risk of disability and functional decline. TRIAL REGISTRATION: Clinicaltrials.gov , NCT03790098 . Registered 31 December 2018 - Retrospectively registered.

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.

Ripple Effects of a Community-Based Randomized Trial for Rural Women: Strong Hearts, Healthy Communities.

OBJECTIVE: This study aimed to examine (1) whether the Strong Hearts, Healthy Communities intervention (SHHC) improved social network members' (SNMs') weight, exercise, and diet and (2) whether SNMs' weight and behavioral changes were modified by their relationship closeness and/or spatial closeness with trial participants. METHODS: Eight towns received the SHHC intervention, which focused on building individual healthy behaviors and creating supportive social and built environments for exercise and healthy eating. Eight towns received an education-only control intervention. SNMs (n = 487) were recruited to complete a questionnaire at baseline and at 6 months that asked about demographics, weight, height, exercise, and eating habits. RESULTS: SHHC's effect on SNMs differed depending on their relationship closeness with trial participants. Among SNMs who had a very close relationship with trial participants, those associated with the intervention group lost more weight and decreased BMI more than those associated with the control group (weight [kilograms] between-group difference: Δ = -1.68; 95% CI: -3.10 to -0.25; P = 0.021; BMI between-group difference: Δ = -0.60; 95% CI: -1.16 to -0.04; P = 0.034). Spatial closeness did not modify any of SHHC's ripple effects. CONCLUSIONS: Relationship closeness, rather than spatial closeness, played an important role in influencing a rural community-based intervention's ripple effects.

Web-Based Dissemination of a Civic Engagement Curriculum to Promote Healthy Eating and Active Living in Rural Towns: The eHEART Study.

Civic engagement interventions aimed at improving food and physical activity environments hold promise in addressing rural health disparities, but ensuring feasible and sustained dissemination remains a challenge. The present study aimed to evaluate the feasibility of a civic engagement curriculum adapted for online dissemination (Healthy Eating and Activity in Rural Towns (eHEART)). The eHEART curriculum and website were developed based on feedback from local health educators and community members. eHEART groups were facilitated by local Extension educators across three rural towns in three U.S. states (Montana, Wisconsin, and Alaska). Implementation feasibility was assessed through monthly project reports and interviews with educators. All eHEART groups successfully completed curriculum activities and met their project goals after nine months (November 2018 to July 2019). Groups ranged in size from 4 to 8 community residents and implemented varied strategies to improve aspects of their local food and/or physical activity environments. Facilitators of implementation included clear guidance on facilitating curriculum activities and the flexible and community-driven nature of eHEART projects. Recommended changes included more guidance on evaluating projects and contacting stakeholders as well as providing online tools and support for project management. Findings from this work have important implications for creating healthier rural environments. Local health educators and other community groups can feasibly use the eHEART curriculum to foster environmental changes that support healthy eating and active living.

Effects of the Strong Hearts, Healthy Communities Intervention on Functional Fitness of Rural Women.

PURPOSE: The purposes of these analyses were to determine whether Strong Hearts, Healthy Communities (SHHC), a multilevel, cardiovascular disease risk reduction program for overweight, sedentary rural women aged 40 or older, led to improved functional fitness, and if changes in fitness accounted for weight loss associated with program participation. METHODS: Sixteen rural communities were randomized to receive the SHHC intervention or a control program. Both programs involved groups of 12-16 participants. The SHHC program met 1 hour twice a week for 24 weeks where participants engaged in aerobic exercise and progressive strength training. Program content addressed diet and social and environmental influences on heart-healthy behavior. The control group met 1 hour each month for 6 months, covering current dietary and physical activity recommendations. Objective measures of functional fitness included the 30-second arm curl, 30-second chair stand, and 2-minute step test. Self-reported functional fitness was measured by the Physical Functioning Subscale of the MOS Short Form-36 (SF-36 PF). FINDINGS: The SHHC program was associated with increased strength and endurance, as represented by greater improvement in the chair stand and step test; and with increased physical function, as represented by the SF-36 PF. Adjustment for change in aerobic endurance, as measured by the step test, accounted for two-thirds of the intervention effect on weight loss at the end of the intervention. CONCLUSIONS: SHHC participants experienced improved performance on objective measures of functional fitness and self-reported measures of physical function, and changes in weight were partially accounted for by changes in aerobic fitness.

Serum carotenoids are strongly associated with dermal carotenoids but not self-reported fruit and vegetable intake among overweight and obese women.

BACKGROUND: Accurate assessment of fruit and vegetable intake (FVI) is essential for public health nutrition research and surveillance. Blood carotenoid concentrations are robust biomarkers of FVI, but collecting blood samples typically is not feasible in population-based studies. Understanding how well non-invasive measures compare to blood estimates is important for advancing surveillance and evaluation. The objective of this study was to examine the associations between serum carotenoids and four non-invasive measures of FVI in overweight and obese women. METHODS: This study utilized baseline data from 157 overweight or obese women (95.5% white, mean age 58.56 years ± 9.49 years) enrolled in the Strong Hearts, Healthy Communities randomized trial, including two direct measures of carotenoids and three self-reported measures of FVI. Participants completed a fasting blood draw, dermal carotenoid scans using resonance Raman spectroscopy (RRS), a two-item FVI screener modeled after the American Heart Association's Life's Simple 7 "My Life Check" tool (modified AHA tool), the National Cancer Institute's All-Day Fruit and Vegetable Screener (FVS), multiple 24-h dietary recalls, physical measurements, and demographic and health behavior questions. We analyzed blood for total carotenoids and derived total FVI estimates from self-report tools. We used multivariate linear regression models to examine associations between each non-invasive tool and serum carotenoids under four scenarios analogous to different research contexts in which varying breadths of participant data are available. We also calculated adjusted Pearson's correlations between serum carotenoids, dermal carotenoids, and the self-reported measures. RESULTS: Dermal carotenoids were strongly correlated with serum carotenoids (0.71, P < 0.00067) and associated with serum carotenoids in all regression models (0.42-0.43, P < 0.002). None of the self-reported FVI measures were significantly associated with serum or dermal carotenoids in adjusted regression models or correlation analyses. CONCLUSIONS: Compared to self-reported FVI, we found dermal carotenoids measured by RRS to be a superior method to approximate serum carotenoids among overweight and obese women. More research is needed to investigate these assessment methods in diverse populations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02499731, registered July 16, 2015.

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.

Associations between frequency of food shopping at different food sources and fruit and vegetable intake among rural residents in upstate New York, USA.

OBJECTIVE: To examine the frequency of shopping at different food sources and the associations between shopping at different food sources and fruit and vegetable (FV) intake among upstate New York rural residents. DESIGN: Cross-sectional study. Descriptive statistics and linear mixed models were used. SETTING: Eighty-two rural communities in upstate New York, USA. PARTICIPANTS: Adults (n 465; 82·3 % female, mean age 51·5 years, mean BMI 31·7 kg/m2). RESULTS: Within one's community, the majority of participants reported often going to supermarkets (73·1 %). Many participants sometimes or occasionally shopped at superstores (48·0 %), convenience stores (57·9 %), small grocery stores or local markets (57·2 %), farmers' markets or FV stores (66·6 %), dollar stores (51·5 %), pharmacies (46·0 %), or farm stands or community-supported agriculture (56·8 %). Most participants had never utilized food banks or food pantries (94·0 %), community gardens (92·7 %) or home food delivery (91·9 %). While frequent visits to farmers' markets or farm stands were associated with higher fruit intake (P < 0·001), frequent visits to food co-ops or food hubs were associated with lower fruit intake (P = 0·004). Frequent visits to convenience stores (P = 0·002) and dollar stores (P = 0·004) were associated with lower vegetable intake. When FV intakes were combined, frequent visits to farmers' markets or farm stands (P < 0·001) were associated with higher FV intake, and frequent visits to convenience stores (P = 0·005) were associated with lower FV intake. CONCLUSIONS: Findings from the present study provide important insight for informing future food environment interventions related to helping rural residents consume adequate FV.

Cost-effectiveness of a community-based cardiovascular disease prevention intervention in medically underserved rural areas.

BACKGROUND: Rural women experience health disparities in terms of cardiovascular disease (CVD) risk compared to urban women. Cost-effective CVD-prevention programs are needed for this population. The objective of this study was to conduct cost analysis and cost-effectiveness analyses (CEAs) of the Strong Hearts, Healthy Communities (SHHC) program compared to a control program in terms of change in CVD risk factors, including body weight and quality-adjusted life years (QALYs). METHODS: Sixteen medically underserved rural towns in Montana and New York were randomly assigned to SHHC, a six-month twice-weekly experiential learning lifestyle program focused predominantly on diet and physical activity behaviors (n = 101), or a monthly healthy lifestyle education-only control program (n = 93). Females who were sedentary, overweight or obese, and aged 40 years or older were enrolled. The cost analysis calculated the total and per participant resource costs as well as participants' costs for the SHHC and control programs. In the intermediate health outcomes CEAs, the incremental costs were compared to the incremental changes in the outcomes. The QALY CEA compares the incremental costs and effectiveness of a national SHHC intervention for a hypothetical cohort of 2.2 million women compared to the status quo alternative. RESULTS: The resource cost of SHHC was $775 per participant. The incremental cost-effectiveness ratios from the payer's perspective was $360 per kg of weight loss. Over a 10-year time horizon, to avert per QALY lost SHHC is estimated to cost $238,271 from the societal perspective, but only $62,646 from the healthcare sector perspective. Probabilistic sensitivity analyses show considerable uncertainty in the estimated incremental cost-effectiveness ratios. CONCLUSIONS: A national SHHC intervention is likely to be cost-effective at willingness-to-pay thresholds based on guidelines for federal regulatory impact analysis, but may not be at commonly used lower threshold values. However, it is possible that program costs in rural areas are higher than previously studied programs in more urban areas, due to a lack of staff and physical activity resources as well as  availability for partnerships with existing organizations. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02499731 , registered on July 16, 2015.

Strong Hearts for New York: A multilevel community-based randomized cardiovascular disease risk reduction intervention for rural women.

BACKGROUND: Rural midlife and older women have high rates of cardiovascular disease (CVD) risk factors and lower access to healthy living resources. The Strong Hearts, Healthy Communities (SHHC) intervention, tailored to the needs of rural women, demonstrated effectiveness on many outcomes. The purpose of the Strong Hearts for New York (SHNY) study is to evaluate the efficacy of an enhanced version of the curriculum (SHHC-2.0). METHODS: SHNY is a randomized controlled efficacy intervention, comparing participants receiving the SHHC-2.0 curriculum with a delayed intervention control group. SHHC, informed by formative research, includes core elements from three evidence-based programs. Changes based on extensive outcome and process evaluation data were made to create SHHC-2.0. Classes will meet twice weekly for 24 weeks and include individual, social, and environmental components. Overweight women age 40 and over will be recruited from 11 rural, medically underserved communities in New York; data will be collected at baseline and 12, 24, 36, and 48 weeks across individual, social, and environmental levels. Primary outcome is body weight. Secondary outcomes include Simple 7 (composite CVD risk score), anthropometric, physiologic, biochemical, physical activity, and dietary intake measures; healthy eating and exercise self-efficacy and attitudes; and self-efficacy of the social network of participants. DISCUSSION: The aims of this study are to evaluate the efficacy of the enhanced SHHC-2.0 program for participants, changes among participants' social networks, and the difference in outcomes when participants are and are not provided with technological tools (Fitbit and body composition scale).

Use of an Online Diet Goal-Setting Tool: Relationships With Gestational Weight Gain.

OBJECTIVES: To describe (1) the use of a diet goal-setting tool in a self-directed online intervention aimed at promoting a healthy lifestyle, and (2) the association of tool use with gestational weight gain (GWG). DESIGN: Cross-sectional analysis of data from the intervention group in a randomized effectiveness trial. SETTING: An urban county in the northeastern US. PARTICIPANTS: A total of 898 healthy pregnant women aged 18-35 years with body mass indexes of (BMI) ≥18.5 and <35; 39.1% were low-income. MAIN OUTCOME MEASURES: Physical, sociodemographic, and psychosocial characteristics; use of tool features; and GWG. ANALYSIS: Frequencies, chi-square tests of independence, and regression analysis. RESULTS: Use of the online dietary tool was 45.1% completed the assessment, 35.3% set a goal, and 22.6% engaged in self-monitoring. Among women with normal BMI, setting ≥2 goals and engaging in self-monitoring were significantly (P < .05) associated with less GWG. Among women with higher BMI, setting ≥2 goals was significantly associated with greater GWG. CONCLUSIONS AND IMPLICATIONS: Although online diet goal setting is a potentially effective weight management tool for pregnant women with normal BMI, findings suggest that it may not be for higher-BMI women. Additional research is needed to explain this finding.