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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Cardiovascular Disease; Overweight; Sedentary Lifestyle; Heart Disease
• Intervention / Treatment: Behavioral: Group 1 (Intervention); Behavioral: Group 2 (Delayed intervention)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Clyde, New York, United States, 14433
      • Clyde
    • Cobleskill, New York, United States, 12043
      • Cobleskill
    • Cooperstown, New York, United States, 13326
      • Cooperstown
    • Dolgeville, New York, United States, 13329
      • Dolgeville and Little Falls
    • Hamilton, New York, United States, 13346
      • Hamilton
    • Hartwick, New York, United States, 13348
      • Hartwick
    • Herkimer, New York, United States, 13350
      • Herkimer, Mohawk and Ilion
    • Ithaca, New York, United States, 14853
      • Ithaca
    • Ithaca, New York, United States, 14853
      • Seguin Research Lab, Cornell University
    • Milford, New York, United States, 13807
      • Milford
    • Morrisville, New York, United States, 13408
      • Morrisville
    • Newark, New York, United States, 14513
      • Newark
    • Sharon Springs, New York, United States, 13459
      • Sharon Springs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (Intervention); 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); 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".
Experimental: Group 2 (Delayed intervention); Delayed intervention participants will participate in the same activities as Group 1 but 6 months after Group 1.	Behavioral: Group 2 (Delayed intervention); 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".

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Cornell University
• Collaborators: Tufts University; Montana State University; Bassett Healthcare; Cornell Cooperative Extension
• Investigators: Principal Investigator: Rebecca Seguin, PhD, Cornell University

Publications and helpful links

General Publications

• Seguin-Fowler RA, Eldridge GD, Rethorst CD, Graham ML, Demment M, Strogatz D, Folta SC, Maddock JE, Nelson ME, Ha S. Improvements and Maintenance of Clinical and Functional Measures Among Rural Women: Strong Hearts, Healthy Communities-2. 0 Cluster Randomized Trial. Circ Cardiovasc Qual Outcomes. 2022 Nov;15(11):e009333. doi: 10.1161/CIRCOUTCOMES.122.009333. Epub 2022 Nov 15.
• Seguin-Fowler RA, Strogatz D, Graham ML, Eldridge GD, Marshall GA, Folta SC, Pullyblank K, Nelson ME, Paul L. The Strong Hearts, Healthy Communities Program 2.0: An RCT Examining Effects on Simple 7. Am J Prev Med. 2020 Jul;59(1):32-40. doi: 10.1016/j.amepre.2020.01.027. Epub 2020 May 7.
• Pullyblank K, Strogatz D, Folta SC, Paul L, Nelson ME, Graham M, Marshall GA, Eldridge G, Parry SA, Mebust S, Seguin RA. Effects of the Strong Hearts, Healthy Communities Intervention on Functional Fitness of Rural Women. J Rural Health. 2020 Jan;36(1):104-110. doi: 10.1111/jrh.12361. Epub 2019 Mar 13.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2017
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; nutrition; social network; civic engagement
• Additional Relevant MeSH Terms: Body Weight; Heart Diseases; Cardiovascular Diseases; Overweight
• Other Study ID Numbers: IRB #: 1402004505-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No