Clinical trial NCT03059472: Strong Hearts for New York: A Rural Heart Disease Prevention Study
Official title: Strong Hearts for New York: A Rural Community CVD Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Disease
Cardiovascular Disease
Sedentary Lifestyle
Overweight
Obesity
Keywords: physical activity
nutrition
social network
civic engagement
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: Montana State University
name: Tufts University
name: Bassett Healthcare
name: Cornell Cooperative Extension
First posted: 2017-02-23
Enrollment: 182
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline to 24 weeks
Secondary outcomes:
measure: Changes in body weight
timeFrame: Baseline to 48 weeks
measure: Changes in blood pressure
timeFrame: Baseline to 24 weeks, 48 weeks
measure: Changes in blood lipids
timeFrame: Baseline to 24 weeks, 48 weeks
measure: Changes in c-reactive protein
timeFrame: Baseline to 24 weeks, 48 weeks
measure: Changes in hemoglobin A1C
timeFrame: Baseline to 24 weeks, 48 weeks
measure: Changes in waist circumference
timeFrame: Baseline to 24 weeks, 48 weeks
measure: Changes in hip circumference
timeFrame: Baseline to 24 weeks, 48 weeks
measure: Changes in 7 day accelerometry
timeFrame: Baseline to 24 weeks, 48 weeks
measure: Changes in 7 day dietary recall
timeFrame: Baseline to 24 weeks, 48 weeks
measure: Changes in healthy eating self-efficacy assessed by questionnaire
timeFrame: Baseline to 24 weeks, 48 weeks
measure: Changes in exercise self-efficacy assessed by questionnaire
timeFrame: Baseline to 24 weeks, 48 weeks
measure: Changes in healthy eating attitudes of social network of participants assessed by questionnaire
timeFrame: Baseline to 24 weeks, 48 weeks
measure: Changes in exercise attitudes of social network of participants assessed by questionnaire
timeFrame: Baseline to 24 weeks, 48 weeks
measure: Changes in healthy eating self-efficacy of social network of participants assessed by questionnaire
timeFrame: Baseline to 24 weeks, 48 weeks
measure: Changes in exercise self-efficacy of social network of participants assessed by questionnaire
timeFrame: Baseline to 24 weeks, 48 weeks
Other outcomes:
Locations:
city: Clyde
country: United States
facility: Clyde
state: New York
city: Cobleskill
country: United States
facility: Cobleskill
state: New York
city: Cooperstown
country: United States
facility: Cooperstown
state: New York
city: Dolgeville
country: United States
facility: Dolgeville and Little Falls
state: New York
city: Hamilton
country: United States
facility: Hamilton
state: New York
city: Hartwick
country: United States
facility: Hartwick
state: New York
city: Herkimer
country: United States
facility: Herkimer, Mohawk and Ilion
state: New York
city: Ithaca
country: United States
facility: Ithaca
state: New York
city: Ithaca
country: United States
facility: Seguin Research Lab, Cornell University
state: New York
city: Milford
country: United States
facility: Milford
state: New York
city: Morrisville
country: United States
facility: Morrisville
state: New York
city: Newark
country: United States
facility: Newark
state: New York
city: Sharon Springs
country: United States
facility: Sharon Springs
state: New York
Study officials:
affiliation: Cornell University
name: Rebecca Seguin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.