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.

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.

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.

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.

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.

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.

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.

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).

Strong Hearts, Healthy Communities: A Community-Based Randomized Trial for Rural Women.

OBJECTIVE: The aim of this study was to evaluate a multilevel cardiovascular disease (CVD) prevention program for rural women. METHODS: This 6-month, community-based, randomized trial enrolled 194 sedentary rural women aged 40 or older with BMI ≥ 25 kg/m2 . Intervention participants attended 6 months of twice-weekly exercise, nutrition, and heart health classes (48 total) that included individual-, social-, and environment-level components. An education-only control program included didactic healthy lifestyle classes once a month (six total). The primary outcome measures were change in BMI and weight. RESULTS: Within-group and between-group multivariate analyses revealed that only intervention participants decreased BMI (-0.85 units; 95% CI: -1.32 to -0.39; P = 0.001) and weight (-2.24 kg; 95% CI: -3.49 to -0.99; P = 0.002). Compared with controls, intervention participants decreased BMI (difference: -0.71 units; 95% CI: -1.35 to -0.08; P = 0.03) and weight (1.85 kg; 95% CI: -3.55 to -0.16; P = 0.03) and improved C-reactive protein (difference: -1.15 mg/L; 95% CI: -2.16 to -0.15; P = 0.03) and Simple 7, a composite CVD risk score (difference: 0.67; 95% CI: 0.14 to 1.21; P = 0.01). Cholesterol decreased among controls but increased in the intervention group (-7.85 vs. 3.92 mg/dL; difference: 11.77; 95% CI: 0.57 to 22.96; P = 0.04). CONCLUSIONS: The multilevel intervention demonstrated modest but superior and meaningful improvements in BMI and other CVD risk factors compared with the control program.

Effects of parent-only childhood obesity prevention programs on BMIz and body image in rural preteens.

This experiment compared body image (BI) and BMI changes resulting from two parent-only obesity prevention interventions aimed at 8-12 year olds. Parents in the experimental intervention attended ten face-to-face educational sessions, while parents in the minimal (control) intervention received similar mailed information. Parent-child dyads (N=150) were semi-randomly assigned to intervention groups. Children were assessed before, after, and 6 months following the interventions; children did not attend experimental intervention sessions. Child BI assessments included weight and size perception, weight management goals, body esteem, and appearance attitudes. Significant effects included small decreases in BMIz scores and overweight dissatisfaction, as well as improvements in aspects of body esteem and appearance attitudes. Some BI effects were gender-specific. Decreases in overweight dissatisfaction were greater following the experimental treatment. Neither treatment reduced body size misperception. Thus, parent-only obesity prevention interventions can reduce body weight and body image concerns among rural preteens.

Strong Hearts, healthy communities: a rural community-based cardiovascular disease prevention program.

BACKGROUND: Cardiovascular disease is the leading cause of death in the United States and places substantial burden on the health care system. Rural populations, especially women, have considerably higher rates of cardiovascular disease, influenced by poverty, environmental factors, access to health care, and social and cultural attitudes and norms. METHODS/DESIGN: This community-based study will be a two-arm randomized controlled efficacy trial comparing a multi-level, community program (Strong Hearts, Healthy Communities) with a minimal intervention control program (Strong Hearts, Healthy Women). Strong Hearts, Healthy Communities was developed by integrating content from three evidence-based programs and was informed by extensive formative research (e.g. community assessments, focus groups, and key informant interviews). Classes will meet twice weekly for one hour for 24 weeks and focus on individual-level skill building and behavior change; social and civic engagement are also core programmatic elements. Strong Hearts, Healthy Women will meet monthly for hour-long sessions over the 24 weeks covering similar content in a general, condensed format. Overweight, sedentary women 40 years of age and older from rural, medically underserved communities (12 in Montana and 4 in New York) will be recruited; sites, pair-matched based on rurality, will be randomized to full or minimal intervention. Data will be collected at baseline, midpoint, intervention completion, and six-month, one-year, and eighteen months post-intervention. The primary outcome is change in body weight; secondary outcomes include physiologic, anthropometric, behavioral, and psychosocial variables. In the full intervention, engagement of participants' friends and family members in partnered activities and community events is an intervention target, hypothesizing that there will be a reciprocal influence of physical activity and diet behavior between participants and their social network. Family members and/or friends will be invited to complete baseline and follow-up questionnaires about their health behaviors and environment, height and weight, and attitudes and beliefs. DISCUSSION: Strong Hearts, Healthy Communities aims to reduce cardiovascular disease morbidity and mortality, improve quality of life, and reduce cardiovascular disease-related health care burden in underserved rural communities. If successful, the long-term goal is for the program to be nationally disseminated, providing a feasible model to reduce cardiovascular disease in rural settings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02499731 Registered on July 1, 2015.

Understanding barriers and facilitators to healthy eating and active living in rural communities.

Objective. Studies demonstrate that people's food and physical activity (PA) environments influence behavior, yet research examining this in rural communities is limited. Methods. Focus groups of 8-15 women were conducted in rural communities in seven US states. Questions were designed to identify factors within residents' food and PA environments they felt helped or hindered them from eating healthfully and being physically active. Results. Participants were aged 30-84 years; mean (SD) = 61 (14) (N = 95). On average, communities had fewer than 5,000 residents. Limited time, social norms, and distances from or lack of exercise facilities were common PA barriers. Facilitators for PA included social support, dog walking, and availability of affordable facilities. Healthy eating barriers included the perception that healthy foods were too expensive; calorically dense large portion sizes served at family meals; and frequency of eating foods away from home, which were perceived as generally unhealthy. Healthy eating supports included culture/value around local food gathering (e.g., hunting and gardening) and preservation (e.g., canning and smoking). Friends and family were frequently identified as key influencers of eating and PA behavior. Conclusions. Targeting both social and built environment factors, particularly those unique to rural locales, may enhance support for healthy eating and PA behavior change interventions.

Strength Training Improves Body Image and Physical Activity Behaviors Among Midlife and Older Rural Women.

The effect of strength training on body image is understudied. The Strong Women Program, a 10-week, twice weekly strength-training program, was provided by Extension agents to 341 older rural women (62±12 years); changes in body image and other psychosocial variables were evaluated. Paired-sample t-test analyses were conducted to assess mean differences pre- to post-program. Strength training was associated with significant improvements in several dimensions of body image, health-related quality of life, and physical activity behaviors, satisfaction, and comfort among rural aging women-an often underserved population that stands to benefit considerably from similar programs.

Childhood obesity prevention in rural settings: background, rationale, and study design of '4-Health,' a parent-only intervention.

BACKGROUND: Childhood obesity in rural communities is a serious but understudied problem. The current experiment aims to assess a wide range of obesity risk factors among rural youth and to offer an 8-month intervention program for parents to reduce obesity risk in their preteen child. METHODS/DESIGN: A two-group, repeated measures design is used to assess the effectiveness of the 4-Health intervention program. Assessments include anthropometric measures, child self-evaluations, parent self-evaluations, and parent evaluations of child. County Extension agents from 21 rural Montana counties recruit approximately 150 parent-child dyads and counties are semi-randomly assigned to the active intervention group (4-Health Educational Program) or a "best-practices" (Healthy Living Information) control group. DISCUSSION: This study will shed light on the effectiveness of this parent-only intervention strategy in reducing obesity risk factors among rural preteens. The 4-Health program is designed to provide information and skills development for busy rural parents that will increase healthy lifestyles of their preteen children and improve the parents' ability to intervene effectively in the lives of their families during this critical developmental period. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT01510587.