Strong Hearts: Rural CVD Prevention

April 15, 2020 updated by: Cornell University

Strong Hearts, Healthy Communities: A Rural Community CVD Prevention Program

Strong Hearts, Healthy Communities 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.

The investigators' aim is to better understand how changes in lifestyle can affect the health of rural women and others in their communities.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 16 underserved rural towns. In Montana, SHHC builds upon a long-standing collaboration with National Institute of Food and Agriculture cooperative extension educators, who will implement the project. SHHC in New York will work with a health care system to 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 16 medically underserved rural towns to develop and 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.

FORMATIVE RESEARCH (STAGE1: Completed) The investigators conducted community audits, focus groups, and key informant interviews with members of the above key groups to gather in-depth data about a number of topics related to CVD awareness and risk factors. These topics included: economic, healthcare, and social/cultural factors, as well as, barriers and facilitators to healthy eating and active living. The community audit and qualitative data gathered during the formative research, as well as, feedback from extension educators and the National Advisory Board has informed and been incorporated in the development and refinement of the SHHC curriculum.

RANDOMIZED CONTROLLED INTERVENTION (STAGE 2) In the second phase of the project, the investigators will evaluate the efficacy of the SHHC curriculum in a 24-week community based randomized controlled intervention trial. The investigators will compare changes in CVD-related anthropometric, physiologic, behavioral, and psychosocial parameters between subjects in 8 intervention and 8 control communities. In addition, the investigators will evaluate changes in behavior, attitudes, and knowledge among SHHC intervention subjects' "social network".

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
194

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Broadus, Montana, United States, 59317
        • Broadus
      • Chinook, Montana, United States, 59523
        • Chinook
      • Choteau, Montana, United States, 59422
        • Choteau
      • Columbus, Montana, United States, 59019
        • Columbus
      • Forsyth, Montana, United States, 59327
        • Forsyth
      • Glasgow, Montana, United States, 59230
        • Glasgow
      • Harlowton, Montana, United States, 59036
        • Harlowton
      • Hinsdale, Montana, United States, 59241
        • Hinsdale
      • Lewistown, Montana, United States, 59457
        • Lewistown
      • Plentywood, Montana, United States, 59254
        • Plentywood
      • Shelby, Montana, United States, 59474
        • Shelby
      • Thompson Falls, Montana, United States, 59873
        • Thompson Falls
    • New York
      • Cherry Valley, New York, United States, 13320
        • Cherry Valley
      • Little Falls, New York, United States, 13365
        • Little Falls
      • Saint Johnsville, New York, United States, 13452
        • St. Johnsville
      • Sidney, New York, United States, 13838
        • Sidney

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Not currently physically active
  • BMI greater than or equal to 25
  • 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 either intervention
  • Willing to participate in assessment activities
  • Willing to make a firm commitment to participate in either intervention

Exclusion Criteria:

  • Currently physically active
  • Body Mass Index less than 25
  • 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 either intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Strong Hearts, Healthy Communities
Full Intervention participants will meet twice per week for one hour each time, for approximately 6 months plus monthly community meetings and events. Participants will learn and practice good nutrition and physical activity for improved individual, family and community health.
Behavioral: Strong Hearts, Healthy Communities
We will evaluate the efficacy of the SHHC curriculum in a 24-week community-based randomized controlled intervention trial. We will compare changes in CVD-related anthropometric, physiologic, behavioral, and psychosocial parameters between subjects in 8 intervention and 8 control communities. In addition, we will evaluate changes in behavior, attitudes, and knowledge among SHHC intervention subjects' "social network".
Other Names:
  • Strong Hearts for Montana
  • Full intervention
Experimental: Strong Hearts, Healthy Women
Strong Hearts, Healthy Women minimum intervention participants meet once per month for an hour each time for 6 months. Participants will learn and discuss techniques and strategies to improve personal health.
Behavioral: Strong Hearts, Healthy Women

The Strong Hearts, Healthy Women (minimal intervention) will meet once per month for an hour each time for 6 months.

Participants will learn and discuss techniques and strategies to improve personal health.

Other Names:
  • Minimal intervention
  • Strong Hearts for Montana

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in body weight
Time Frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Baseline to 6 months, 6-month follow-up, and 18-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Changes in blood pressure
Time Frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Changes in lipids
Time Frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Changes in c-reactive protein
Time Frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Changes in hemoglobin A1C
Time Frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Changes in waist circumference
Time Frame: Baseline to 3 months, 6 months, 6-month follow-up, and 18-month follow-up
Baseline to 3 months, 6 months, 6-month follow-up, and 18-month follow-up
Changes in 7-day accelerometry
Time Frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Changes in 7-day dietary recall
Time Frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Changes in healthy eating self-efficacy assessed by questionnaire
Time Frame: Baseline to 3 months, 6 months, 6-month follow-up, one-year follow-up, and 18-month follow-up
Baseline to 3 months, 6 months, 6-month follow-up, one-year follow-up, and 18-month follow-up
Changes in exercise self-efficacy assessed by questionnaire
Time Frame: Baseline to 3 months, 6 months, 6-month follow-up, one-year follow-up, and 18-month follow-up
Baseline to 3 months, 6 months, 6-month follow-up, one-year follow-up, and 18-month follow-up
Changes in healthy eating attitudes of social network of participants assessed by questionnaire
Time Frame: Baseline to 6 months and 6-month follow-up
Baseline to 6 months and 6-month follow-up
Changes in exercise attitudes of social network of participants assessed by questionnaire
Time Frame: Baseline to 6 months and 6-month follow-up
Baseline to 6 months and 6-month follow-up
Changes in healthy eating self-efficacy of social network of participants assessed by questionnaire
Time Frame: Baseline to 6 months and 6-month follow-up
Baseline to 6 months and 6-month follow-up
Changes in exercise self-efficacy of social network of participants assessed by questionnaire
Time Frame: Baseline to 6 months and 6-month follow-up
Baseline to 6 months and 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cornell University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tufts University
Montana State University
Bassett Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rebecca Seguin, PhD, Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB #: 1402004505

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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