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

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ClinicalTrials.gov Identifier: NCT03059472
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
Montana State University
Tufts University
Bassett Healthcare
Cornell Cooperative Extension
Information provided by (Responsible Party):
Cornell University

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) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : January 20, 2017
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

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".




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: Baseline to 24 weeks ]

Secondary Outcome Measures :
  1. Changes in body weight [ Time Frame: Baseline to 48 weeks ]
  2. Changes in blood pressure [ Time Frame: Baseline to 24 weeks, 48 weeks ]
  3. Changes in blood lipids [ Time Frame: Baseline to 24 weeks, 48 weeks ]
  4. Changes in c-reactive protein [ Time Frame: Baseline to 24 weeks, 48 weeks ]
  5. Changes in hemoglobin A1C [ Time Frame: Baseline to 24 weeks, 48 weeks ]
  6. Changes in waist circumference [ Time Frame: Baseline to 24 weeks, 48 weeks ]
  7. Changes in hip circumference [ Time Frame: Baseline to 24 weeks, 48 weeks ]
  8. Changes in 7 day accelerometry [ Time Frame: Baseline to 24 weeks, 48 weeks ]
  9. Changes in 7 day dietary recall [ Time Frame: Baseline to 24 weeks, 48 weeks ]
  10. Changes in healthy eating self-efficacy assessed by questionnaire [ Time Frame: Baseline to 24 weeks, 48 weeks ]
  11. Changes in exercise self-efficacy assessed by questionnaire [ Time Frame: Baseline to 24 weeks, 48 weeks ]
  12. Changes in healthy eating attitudes of social network of participants assessed by questionnaire [ Time Frame: Baseline to 24 weeks, 48 weeks ]
  13. Changes in exercise attitudes of social network of participants assessed by questionnaire [ Time Frame: Baseline to 24 weeks, 48 weeks ]
  14. Changes in healthy eating self-efficacy of social network of participants assessed by questionnaire [ Time Frame: Baseline to 24 weeks, 48 weeks ]
  15. Changes in exercise self-efficacy of social network of participants assessed by questionnaire [ Time Frame: Baseline to 24 weeks, 48 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059472


Locations
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United States, New York
Clyde
Clyde, New York, United States, 14433
Cobleskill
Cobleskill, New York, United States, 12043
Cooperstown
Cooperstown, New York, United States, 13326
Dolgeville and Little Falls
Dolgeville, New York, United States, 13329
Hamilton
Hamilton, New York, United States, 13346
Hartwick
Hartwick, New York, United States, 13348
Herkimer, Mohawk and Ilion
Herkimer, New York, United States, 13350
Ithaca
Ithaca, New York, United States, 14853
Seguin Research Lab, Cornell University
Ithaca, New York, United States, 14853
Milford
Milford, New York, United States, 13807
Morrisville
Morrisville, New York, United States, 13408
Newark
Newark, New York, United States, 14513
Sharon Springs
Sharon Springs, New York, United States, 13459
Sponsors and Collaborators
Cornell University
Montana State University
Tufts University
Bassett Healthcare
Cornell Cooperative Extension
Investigators
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Principal Investigator: Rebecca Seguin, PhD Cornell University

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Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT03059472     History of Changes
Other Study ID Numbers: IRB #: 1402004505-2
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cornell University:
physical activity
nutrition
social network
civic engagement
Additional relevant MeSH terms:
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Heart Diseases
Overweight
Cardiovascular Diseases
Body Weight
Signs and Symptoms