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

Sponsor

Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT03059472

Collaborator

Montana State University (Other), Tufts University (Other), Bassett Healthcare (Other), Cornell Cooperative Extension (Other)

182

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Disease Cardiovascular Disease Sedentary Lifestyle Overweight Obesity	Behavioral: Group 1 (Intervention) Behavioral: Group 2 (Delayed intervention)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

182 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 31, 2017

Actual Primary Completion Date :

Feb 28, 2019

Actual Study Completion Date :

Feb 28, 2019

Arms and Interventions

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".

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)

Outcome Measures

Primary Outcome Measures

Change in body weight [Baseline to 24 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clyde	Clyde	New York	United States	14433
2	Cobleskill	Cobleskill	New York	United States	12043
3	Cooperstown	Cooperstown	New York	United States	13326
4	Dolgeville and Little Falls	Dolgeville	New York	United States	13329
5	Hamilton	Hamilton	New York	United States	13346
6	Hartwick	Hartwick	New York	United States	13348
7	Herkimer, Mohawk and Ilion	Herkimer	New York	United States	13350
8	Ithaca	Ithaca	New York	United States	14853
9	Seguin Research Lab, Cornell University	Ithaca	New York	United States	14853
10	Milford	Milford	New York	United States	13807
11	Morrisville	Morrisville	New York	United States	13408
12	Newark	Newark	New York	United States	14513
13	Sharon Springs	Sharon Springs	New York	United States	13459