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Strong Hearts: Rural CVD Prevention

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ClinicalTrials.gov Identifier: NCT02499731
Recruitment Status : Active, not recruiting
First Posted : July 16, 2015
Last Update Posted : March 11, 2019
Sponsor:
Collaborators:
Montana State University
Tufts University
Bassett Healthcare
Information provided by (Responsible Party):
Cornell University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Heart Disease Cardiovascular Disease Sedentary Lifestyle Overweight Obesity Behavioral: Strong Hearts, Healthy Communities Behavioral: Strong Hearts, Healthy Women 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 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".


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Strong Hearts, Healthy Communities: A Rural Community CVD Prevention Program
Study Start Date : March 2014
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
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:
  • Strong Hearts for Montana
  • Minimal intervention




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up ]

Secondary Outcome Measures :
  1. Changes in blood pressure [ Time Frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up ]
  2. Changes in lipids [ Time Frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up ]
  3. Changes in c-reactive protein [ Time Frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up ]
  4. Changes in hemoglobin A1C [ Time Frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up ]
  5. Changes in waist circumference [ Time Frame: Baseline to 3 months, 6 months, 6-month follow-up, and 18-month follow-up ]
  6. Changes in 7-day accelerometry [ Time Frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up ]
  7. Changes in 7-day dietary recall [ Time Frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up ]
  8. 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 ]
  9. 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 ]
  10. Changes in healthy eating attitudes of social network of participants assessed by questionnaire [ Time Frame: Baseline to 6 months and 6-month follow-up ]
  11. Changes in exercise attitudes of social network of participants assessed by questionnaire [ Time Frame: Baseline to 6 months and 6-month follow-up ]
  12. 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 ]
  13. Changes in exercise self-efficacy of social network of participants assessed by questionnaire [ Time Frame: Baseline to 6 months and 6-month follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02499731


Locations
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United States, Montana
Broadus
Broadus, Montana, United States, 59317
Chinook
Chinook, Montana, United States, 59523
Choteau
Choteau, Montana, United States, 59422
Columbus
Columbus, Montana, United States, 59019
Forsyth
Forsyth, Montana, United States, 59327
Glasgow
Glasgow, Montana, United States, 59230
Harlowton
Harlowton, Montana, United States, 59036
Hinsdale
Hinsdale, Montana, United States, 59241
Lewistown
Lewistown, Montana, United States, 59457
Plentywood
Plentywood, Montana, United States, 59254
Shelby
Shelby, Montana, United States, 59474
Thompson Falls
Thompson Falls, Montana, United States, 59873
United States, New York
Cherry Valley
Cherry Valley, New York, United States, 13320
Little Falls
Little Falls, New York, United States, 13365
St. Johnsville
Saint Johnsville, New York, United States, 13452
Sidney
Sidney, New York, United States, 13838
Sponsors and Collaborators
Cornell University
Montana State University
Tufts University
Bassett Healthcare
Investigators
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Principal Investigator: Rebecca Seguin, PhD Cornell University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT02499731     History of Changes
Other Study ID Numbers: IRB #: 1402004505
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Keywords provided by Cornell University:
physical activity
nutrition
social network
Additional relevant MeSH terms:
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Heart Diseases
Overweight
Cardiovascular Diseases
Body Weight
Signs and Symptoms