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

Cornell University

Status: Completed

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

Treatments: Behavioral: Group 2 (Delayed intervention); Behavioral: Group 1 (Intervention)

Study type: Interventional

Funder types: Other

Identifiers

NCT03059472

IRB #: 1402004505-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 patients

Sex: Female

Ages: 40 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Group 1 (Intervention)

Experimental group

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.

Treatment:

Behavioral: Group 1 (Intervention)

Group 2 (Delayed intervention)

Experimental group

Description:

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

Treatment:

Behavioral: Group 2 (Delayed intervention)