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

NCT ID: NCT03059472

Last Updated: 2022-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-31
• Study Completion Date: 2019-02-28

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.

Conditions

Heart Disease; Cardiovascular Disease; Sedentary Lifestyle; Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Group 1 (Intervention)

Intervention Type: BEHAVIORAL

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".

Group 2 (Delayed intervention)

Delayed intervention participants will participate in the same activities as Group 1 but 6 months after Group 1.

Group Type: EXPERIMENTAL

Group 2 (Delayed intervention)

Intervention Type: BEHAVIORAL

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".

Interventions

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".

Intervention Type: 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".

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Montana State University

OTHER

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: collaborator

Bassett Healthcare

OTHER

Sponsor Role: collaborator

Cornell Cooperative Extension

UNKNOWN

Sponsor Role: collaborator

Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Seguin, PhD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Locations

Clyde

Clyde, New York, United States

Cobleskill

Cobleskill, New York, United States

Cooperstown

Cooperstown, New York, United States

Dolgeville and Little Falls

Dolgeville, New York, United States

Hamilton

Hamilton, New York, United States

Hartwick

Hartwick, New York, United States

Herkimer, Mohawk and Ilion

Herkimer, New York, United States

Ithaca

Ithaca, New York, United States

Seguin Research Lab, Cornell University

Ithaca, New York, United States

Milford

Milford, New York, United States

Morrisville

Morrisville, New York, United States

Newark

Newark, New York, United States

Sharon Springs

Sharon Springs, New York, United States

Countries

United States

References

Andreyeva E, Graham ML, Eldridge GD, Folta SC, Nelson ME, Strogatz D, Seguin-Fowler RA. Cost-Effectiveness of Two Iterations of a Community-Based Cardiovascular Disease Prevention Intervention. Obesity (Silver Spring). 2025 Oct 16. doi: 10.1002/oby.70050. Online ahead of print.

Reference Type: DERIVED

PMID: 41102867 (View on PubMed)

Szeszulski J, Rolke LJ, Ayine P, Bailey R, Demment M, Eldridge GD, Folta SC, Graham ML, MacMillan Uribe AL, McNeely A, Nelson ME, Pullyblank K, Rethorst C, Strogatz D, Seguin-Fowler RA. Process evaluation findings from Strong Hearts, Healthy Communities 2.0: a cardiovascular disease prevention intervention for rural women. Int J Behav Nutr Phys Act. 2024 Oct 22;21(1):122. doi: 10.1186/s12966-024-01670-y.

Reference Type: DERIVED

PMID: 39438920 (View on PubMed)

MacMillan Uribe AL, Demment M, Graham ML, Szeszulski J, Rethorst CD, Githinji P, Nelson ME, Strogatz D, Folta SC, Bailey RL, Davis JN, Seguin-Fowler RA. Improvements in dietary intake, behaviors, and psychosocial measures in a community-randomized cardiovascular disease risk reduction intervention: Strong Hearts, Healthy Communities 2.0. Am J Clin Nutr. 2023 Nov;118(5):1055-1066. doi: 10.1016/j.ajcnut.2023.09.003. Epub 2023 Sep 17.

Reference Type: DERIVED

PMID: 37717638 (View on PubMed)

Maddock JE, Demment M, Graham M, Folta S, Strogatz D, Nelson M, Ha SY, Eldridge GD, Seguin-Fowler RA. Changes in physical activity outcomes in the Strong Hearts, Healthy Communities (SHHC-2.0) community-based randomized trial. Int J Behav Nutr Phys Act. 2022 Dec 28;19(1):159. doi: 10.1186/s12966-022-01401-1.

Reference Type: DERIVED

PMID: 36578002 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36378768 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32389532 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30865324 (View on PubMed)

Other Identifiers

IRB #: 1402004505-2

Identifier Type: -

Identifier Source: org_study_id