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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059472
• Other study ID #: IRB #: 1402004505-2
• Status: Completed
• Phase: N/A
• Start date: March 31, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: January 2022
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Heart Disease
• Heart Diseases
• Obesity
• Overweight
• Sedentary Lifestyle

Intervention

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".
• 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".

Locations

Country	Name	City	State
United States	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

Sponsors (5)

Lead Sponsor	Collaborator
Cornell University	Bassett Healthcare, Cornell Cooperative Extension, Montana State University, Tufts University

Country where clinical trial is conducted

United States, 

Outcome

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