Strong Hearts for New York: A Rural Heart Disease Prevention Study
Primary Purpose
Heart Disease, Cardiovascular Disease, Sedentary Lifestyle
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group 1 (Intervention)
Group 2 (Delayed intervention)
Sponsored by

About this trial
This is an interventional prevention trial for Heart Disease focused on measuring physical activity, nutrition, social network, civic engagement
Eligibility Criteria
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
Sites / Locations
- Clyde
- Cobleskill
- Cooperstown
- Dolgeville and Little Falls
- Hamilton
- Hartwick
- Herkimer, Mohawk and Ilion
- Ithaca
- Seguin Research Lab, Cornell University
- Milford
- Morrisville
- Newark
- Sharon Springs
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1 (Intervention)
Group 2 (Delayed intervention)
Arm Description
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.
Delayed intervention participants will participate in the same activities as Group 1 but 6 months after Group 1.
Outcomes
Primary Outcome Measures
Change in body weight
Secondary Outcome Measures
Changes in body weight
Changes in blood pressure
Changes in blood lipids
Changes in c-reactive protein
Changes in hemoglobin A1C
Changes in waist circumference
Changes in hip circumference
Changes in 7 day accelerometry
Changes in 7 day dietary recall
Changes in healthy eating self-efficacy assessed by questionnaire
Changes in exercise self-efficacy assessed by questionnaire
Changes in healthy eating attitudes of social network of participants assessed by questionnaire
Changes in exercise attitudes of social network of participants assessed by questionnaire
Changes in healthy eating self-efficacy of social network of participants assessed by questionnaire
Changes in exercise self-efficacy of social network of participants assessed by questionnaire
Full Information
NCT ID
NCT03059472
First Posted
February 13, 2017
Last Updated
January 3, 2022
Sponsor
Cornell University
Collaborators
Montana State University, Tufts University, Bassett Healthcare, Cornell Cooperative Extension
1. Study Identification
Unique Protocol Identification Number
NCT03059472
Brief Title
Strong Hearts for New York: A Rural Heart Disease Prevention Study
Official Title
Strong Hearts for New York: A Rural Community CVD Prevention Program
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 31, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornell University
Collaborators
Montana State University, Tufts University, Bassett Healthcare, Cornell Cooperative Extension
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease, Cardiovascular Disease, Sedentary Lifestyle, Overweight, Obesity
Keywords
physical activity, nutrition, social network, civic engagement
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (Intervention)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2 (Delayed intervention)
Arm Type
Experimental
Arm Description
Delayed intervention participants will participate in the same activities as Group 1 but 6 months after Group 1.
Intervention Type
Behavioral
Intervention Name(s)
Group 1 (Intervention)
Intervention Description
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".
Intervention Type
Behavioral
Intervention Name(s)
Group 2 (Delayed intervention)
Intervention Description
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".
Primary Outcome Measure Information:
Title
Change in body weight
Time Frame
Baseline to 24 weeks
Secondary Outcome Measure Information:
Title
Changes in body weight
Time Frame
Baseline to 48 weeks
Title
Changes in blood pressure
Time Frame
Baseline to 24 weeks, 48 weeks
Title
Changes in blood lipids
Time Frame
Baseline to 24 weeks, 48 weeks
Title
Changes in c-reactive protein
Time Frame
Baseline to 24 weeks, 48 weeks
Title
Changes in hemoglobin A1C
Time Frame
Baseline to 24 weeks, 48 weeks
Title
Changes in waist circumference
Time Frame
Baseline to 24 weeks, 48 weeks
Title
Changes in hip circumference
Time Frame
Baseline to 24 weeks, 48 weeks
Title
Changes in 7 day accelerometry
Time Frame
Baseline to 24 weeks, 48 weeks
Title
Changes in 7 day dietary recall
Time Frame
Baseline to 24 weeks, 48 weeks
Title
Changes in healthy eating self-efficacy assessed by questionnaire
Time Frame
Baseline to 24 weeks, 48 weeks
Title
Changes in exercise self-efficacy assessed by questionnaire
Time Frame
Baseline to 24 weeks, 48 weeks
Title
Changes in healthy eating attitudes of social network of participants assessed by questionnaire
Time Frame
Baseline to 24 weeks, 48 weeks
Title
Changes in exercise attitudes of social network of participants assessed by questionnaire
Time Frame
Baseline to 24 weeks, 48 weeks
Title
Changes in healthy eating self-efficacy of social network of participants assessed by questionnaire
Time Frame
Baseline to 24 weeks, 48 weeks
Title
Changes in exercise self-efficacy of social network of participants assessed by questionnaire
Time Frame
Baseline to 24 weeks, 48 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Seguin, PhD
Organizational Affiliation
Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clyde
City
Clyde
State/Province
New York
ZIP/Postal Code
14433
Country
United States
Facility Name
Cobleskill
City
Cobleskill
State/Province
New York
ZIP/Postal Code
12043
Country
United States
Facility Name
Cooperstown
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
Facility Name
Dolgeville and Little Falls
City
Dolgeville
State/Province
New York
ZIP/Postal Code
13329
Country
United States
Facility Name
Hamilton
City
Hamilton
State/Province
New York
ZIP/Postal Code
13346
Country
United States
Facility Name
Hartwick
City
Hartwick
State/Province
New York
ZIP/Postal Code
13348
Country
United States
Facility Name
Herkimer, Mohawk and Ilion
City
Herkimer
State/Province
New York
ZIP/Postal Code
13350
Country
United States
Facility Name
Ithaca
City
Ithaca
State/Province
New York
ZIP/Postal Code
14853
Country
United States
Facility Name
Seguin Research Lab, Cornell University
City
Ithaca
State/Province
New York
ZIP/Postal Code
14853
Country
United States
Facility Name
Milford
City
Milford
State/Province
New York
ZIP/Postal Code
13807
Country
United States
Facility Name
Morrisville
City
Morrisville
State/Province
New York
ZIP/Postal Code
13408
Country
United States
Facility Name
Newark
City
Newark
State/Province
New York
ZIP/Postal Code
14513
Country
United States
Facility Name
Sharon Springs
City
Sharon Springs
State/Province
New York
ZIP/Postal Code
13459
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36378768
Citation
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.
Results Reference
derived
PubMed Identifier
32389532
Citation
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.
Results Reference
derived
PubMed Identifier
30865324
Citation
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.
Results Reference
derived
Learn more about this trial
Strong Hearts for New York: A Rural Heart Disease Prevention Study
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