Strong Hearts for New York: A Rural Heart Disease Prevention Study

Study Overview
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Brief Summary
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Strong Hearts for New York is a research study which aims to reduce cardiovascular disease (CVD), improve quality of life, and reduce CVD related health care costs in rural communities. Our aim is to better understand how changes in lifestyle can affect the health of rural women and others in their communities.

Detailed Description
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There are notable cardiovascular disease (CVD) disparities among people living in rural settings, particularly medically underserved rural areas. Complex factors such as socioeconomic disadvantage, social and cultural dynamics, geographic distances/barriers, and limited access to healthcare, healthy foods, and/or physical activity opportunities contribute to the issue. The objective of Strong Hearts, Healthy Communities (SHHC) is to reduce rural CVD disparities through civic engagement and implementation of a community-based intervention in 11 underserved New York communities. SHHC builds upon a long-standing collaboration with National Institute of Food and Agriculture cooperative extension educators, who will implement the project. There is limited knowledge about how programs and services can move beyond commonly used individual-level approaches-which have limitations in terms of cost, impact, reach, and sustainability-to effectively reduce rural CVD health disparities using an integrated, multi-level, community-engaged approach. The objective of Strong Hearts, Healthy Communities (SHHC) is to address this gap in knowledge and practice by working with residents, practitioners, health educators, local leadership, and other stakeholders in 11 medically underserved rural communities in New York to test a comprehensive program designed to: a) improve diet and physical activity behaviors, b) promote local built environment resources, and c) shift social norms about active living and healthy eating through civic engagement, capacity building, and community based programming. RANDOMIZED INTERVENTION AND DELAYED INTERVENTION: In the current phase of the project, the efficacy of the SHHC program curriculum will be evaluated in a 24-week delayed intervention trial. The investigators will compare changes in CVD-related anthropometric, physiologic, behavioral, and psychosocial parameters between subjects in 5 intervention and 6 delayed communities in New York State. In addition, changes in behavior, attitudes, and knowledge among SHHC intervention subjects' social network will be evaluated.

Official Title
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Strong Hearts for New York: A Rural Community CVD Prevention Program

Conditions
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Heart Disease, Cardiovascular Disease, Sedentary Lifestyle, Overweight, Obesity

Intervention / Treatment
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* Behavioral: Group 1 (Intervention)
* Behavioral: Group 2 (Delayed intervention)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index (BMI) greater than or equal to 25 If BMI is less than 30, not currently physically active Blood pressure is less than 160/100 mm Hg Heart rate is between 60-100 bpm English-speaking Able and willing to obtain physician's approval to participate in intervention starting either in March 2017 or September 2017 Willing to participate in assessment activities Willing to make a firm commitment to participate in intervention starting either in Spring or Fall 2017 Exclusion Criteria: BMI less than 25 If BMI is less than 30, currently physically active Untreated hypertension Heart rate lower than 60 or higher than 100 bpm Non-English speaking Not able or willing to obtain physician's approval to participate Not interested or willing to participate in assessment activities Not able or willing to make a firm commitment to participate in intervention starting either in Spring or Fall 2017

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (Intervention)<br>Full Intervention participants will meet twice per week for one hour each time, for approximately 6 months. Participants will learn and practice good nutrition and physical activity for improved individual, family and community health. | Behavioral: Group 1 (Intervention)<br>* The investigators will evaluate the efficacy of the SHHC curriculum in a 24-week community-based randomized delayed intervention trial. They will compare changes in CVD-related anthropometric, physiologic, behavioral, and psychosocial parameters between subjects in 5 intervention and 6 delayed intervention communities. In addition, the investigators will evaluate changes in behavior, attitudes, and knowledge among SHHC intervention subjects' social network.<br>|
| Experimental: Group 2 (Delayed intervention)<br>Delayed intervention participants will participate in the same activities as Group 1 but 6 months after Group 1. | Behavioral: Group 2 (Delayed intervention)<br>* The investigators will evaluate the efficacy of the SHHC curriculum in a 24-week community-based randomized delayed intervention trial. They will compare changes in CVD-related anthropometric, physiologic, behavioral, and psychosocial parameters between subjects in 5 intervention and 6 delayed intervention communities. In addition, the investigators will evaluate changes in behavior, attitudes, and knowledge among SHHC intervention subjects' social network.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | Baseline to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight |  | Baseline to 48 weeks | 
| Changes in blood pressure |  | Baseline to 24 weeks, 48 weeks | 
| Changes in blood lipids |  | Baseline to 24 weeks, 48 weeks | 
| Changes in c-reactive protein |  | Baseline to 24 weeks, 48 weeks | 
| Changes in hemoglobin A1C |  | Baseline to 24 weeks, 48 weeks | 
| Changes in waist circumference |  | Baseline to 24 weeks, 48 weeks | 
| Changes in hip circumference |  | Baseline to 24 weeks, 48 weeks | 
| Changes in 7 day accelerometry |  | Baseline to 24 weeks, 48 weeks | 
| Changes in 7 day dietary recall |  | Baseline to 24 weeks, 48 weeks | 
| Changes in healthy eating self-efficacy assessed by questionnaire |  | Baseline to 24 weeks, 48 weeks | 
| Changes in exercise self-efficacy assessed by questionnaire |  | Baseline to 24 weeks, 48 weeks | 
| Changes in healthy eating attitudes of social network of participants assessed by questionnaire |  | Baseline to 24 weeks, 48 weeks | 
| Changes in exercise attitudes of social network of participants assessed by questionnaire |  | Baseline to 24 weeks, 48 weeks | 
| Changes in healthy eating self-efficacy of social network of participants assessed by questionnaire |  | Baseline to 24 weeks, 48 weeks | 
| Changes in exercise self-efficacy of social network of participants assessed by questionnaire |  | Baseline to 24 weeks, 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, nutrition, social network, civic engagement