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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03059472
Enrollment
182
Registered
2017-02-23
Start date
2017-03-31
Completion date
2019-02-28
Last updated
2022-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Heart Disease, Obesity, Overweight, Sedentary Lifestyle

Keywords

physical activity, nutrition, social network, civic engagement

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.

Interventions

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.

BEHAVIORALGroup 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.

Sponsors

Montana State University
CollaboratorOTHER
Tufts University
CollaboratorOTHER
Bassett Healthcare
CollaboratorOTHER
Cornell Cooperative Extension
CollaboratorUNKNOWN
Cornell University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in body weightBaseline to 24 weeks

Secondary

MeasureTime frame
Changes in blood pressureBaseline to 24 weeks, 48 weeks
Changes in blood lipidsBaseline to 24 weeks, 48 weeks
Changes in c-reactive proteinBaseline to 24 weeks, 48 weeks
Changes in hemoglobin A1CBaseline to 24 weeks, 48 weeks
Changes in waist circumferenceBaseline to 24 weeks, 48 weeks
Changes in hip circumferenceBaseline to 24 weeks, 48 weeks
Changes in 7 day accelerometryBaseline to 24 weeks, 48 weeks
Changes in body weightBaseline to 48 weeks
Changes in healthy eating self-efficacy assessed by questionnaireBaseline to 24 weeks, 48 weeks
Changes in exercise self-efficacy assessed by questionnaireBaseline to 24 weeks, 48 weeks
Changes in healthy eating attitudes of social network of participants assessed by questionnaireBaseline to 24 weeks, 48 weeks
Changes in exercise attitudes of social network of participants assessed by questionnaireBaseline to 24 weeks, 48 weeks
Changes in healthy eating self-efficacy of social network of participants assessed by questionnaireBaseline to 24 weeks, 48 weeks
Changes in exercise self-efficacy of social network of participants assessed by questionnaireBaseline to 24 weeks, 48 weeks
Changes in 7 day dietary recallBaseline to 24 weeks, 48 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026