Strong Hearts: Rural CVD Prevention
Primary Purpose
Heart Disease, Cardiovascular Disease, Sedentary Lifestyle
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strong Hearts, Healthy Communities
Strong Hearts, Healthy Women
Sponsored by

About this trial
This is an interventional prevention trial for Heart Disease focused on measuring physical activity, nutrition, social network
Eligibility 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
Sites / Locations
- Broadus
- Chinook
- Choteau
- Columbus
- Forsyth
- Glasgow
- Harlowton
- Hinsdale
- Lewistown
- Plentywood
- Shelby
- Thompson Falls
- Cherry Valley
- Little Falls
- St. Johnsville
- Sidney
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Strong Hearts, Healthy Communities
Strong Hearts, Healthy Women
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in body weight
Secondary Outcome Measures
Changes in blood pressure
Changes in lipids
Changes in c-reactive protein
Changes in hemoglobin A1C
Changes in waist circumference
Changes in 7-day accelerometry
Changes in 7-day dietary recall
Changes in healthy eating self-efficacy assessed by questionnaire
Changes in exercise self-efficacy assessed by questionnaire
Changes in healthy eating attitudes of social network of participants assessed by questionnaire
Changes in exercise attitudes of social network of participants assessed by questionnaire
Changes in healthy eating self-efficacy of social network of participants assessed by questionnaire
Changes in exercise self-efficacy of social network of participants assessed by questionnaire
Full Information
NCT ID
NCT02499731
First Posted
July 1, 2015
Last Updated
April 15, 2020
Sponsor
Cornell University
Collaborators
Montana State University, Tufts University, Bassett Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT02499731
Brief Title
Strong Hearts: Rural CVD Prevention
Official Title
Strong Hearts, Healthy Communities: A Rural Community CVD Prevention Program
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
February 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornell University
Collaborators
Montana State University, Tufts University, Bassett Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease, Cardiovascular Disease, Sedentary Lifestyle, Overweight, Obesity
Keywords
physical activity, nutrition, social network
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Strong Hearts, Healthy Communities
Arm Type
Experimental
Arm Description
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.
Arm Title
Strong Hearts, Healthy Women
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Strong Hearts, Healthy Communities
Other Intervention Name(s)
Strong Hearts for Montana, Full intervention
Intervention Description
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".
Intervention Type
Behavioral
Intervention Name(s)
Strong Hearts, Healthy Women
Other Intervention Name(s)
Strong Hearts for Montana, Minimal intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body weight
Time Frame
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Secondary Outcome Measure Information:
Title
Changes in blood pressure
Time Frame
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Title
Changes in lipids
Time Frame
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Title
Changes in c-reactive protein
Time Frame
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Title
Changes in hemoglobin A1C
Time Frame
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Title
Changes in waist circumference
Time Frame
Baseline to 3 months, 6 months, 6-month follow-up, and 18-month follow-up
Title
Changes in 7-day accelerometry
Time Frame
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Title
Changes in 7-day dietary recall
Time Frame
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Title
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
Title
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
Title
Changes in healthy eating attitudes of social network of participants assessed by questionnaire
Time Frame
Baseline to 6 months and 6-month follow-up
Title
Changes in exercise attitudes of social network of participants assessed by questionnaire
Time Frame
Baseline to 6 months and 6-month follow-up
Title
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
Title
Changes in exercise self-efficacy of social network of participants assessed by questionnaire
Time Frame
Baseline to 6 months and 6-month follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Seguin, PhD
Organizational Affiliation
Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Broadus
City
Broadus
State/Province
Montana
ZIP/Postal Code
59317
Country
United States
Facility Name
Chinook
City
Chinook
State/Province
Montana
ZIP/Postal Code
59523
Country
United States
Facility Name
Choteau
City
Choteau
State/Province
Montana
ZIP/Postal Code
59422
Country
United States
Facility Name
Columbus
City
Columbus
State/Province
Montana
ZIP/Postal Code
59019
Country
United States
Facility Name
Forsyth
City
Forsyth
State/Province
Montana
ZIP/Postal Code
59327
Country
United States
Facility Name
Glasgow
City
Glasgow
State/Province
Montana
ZIP/Postal Code
59230
Country
United States
Facility Name
Harlowton
City
Harlowton
State/Province
Montana
ZIP/Postal Code
59036
Country
United States
Facility Name
Hinsdale
City
Hinsdale
State/Province
Montana
ZIP/Postal Code
59241
Country
United States
Facility Name
Lewistown
City
Lewistown
State/Province
Montana
ZIP/Postal Code
59457
Country
United States
Facility Name
Plentywood
City
Plentywood
State/Province
Montana
ZIP/Postal Code
59254
Country
United States
Facility Name
Shelby
City
Shelby
State/Province
Montana
ZIP/Postal Code
59474
Country
United States
Facility Name
Thompson Falls
City
Thompson Falls
State/Province
Montana
ZIP/Postal Code
59873
Country
United States
Facility Name
Cherry Valley
City
Cherry Valley
State/Province
New York
ZIP/Postal Code
13320
Country
United States
Facility Name
Little Falls
City
Little Falls
State/Province
New York
ZIP/Postal Code
13365
Country
United States
Facility Name
St. Johnsville
City
Saint Johnsville
State/Province
New York
ZIP/Postal Code
13452
Country
United States
Facility Name
Sidney
City
Sidney
State/Province
New York
ZIP/Postal Code
13838
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31718657
Citation
Morgan EH, Graham ML, Marshall GA, Hanson KL, Seguin-Fowler RA. Serum carotenoids are strongly associated with dermal carotenoids but not self-reported fruit and vegetable intake among overweight and obese women. Int J Behav Nutr Phys Act. 2019 Nov 12;16(1):104. doi: 10.1186/s12966-019-0869-3.
Results Reference
derived
PubMed Identifier
31653260
Citation
Folta SC, Paul L, Nelson ME, Strogatz D, Graham M, Eldridge GD, Higgins M, Wing D, Seguin-Fowler RA. Changes in diet and physical activity resulting from the Strong Hearts, Healthy Communities randomized cardiovascular disease risk reduction multilevel intervention trial. Int J Behav Nutr Phys Act. 2019 Oct 25;16(1):91. doi: 10.1186/s12966-019-0852-z.
Results Reference
derived
PubMed Identifier
31096977
Citation
Wang H, Kenkel D, Graham ML, Paul LC, Folta SC, Nelson ME, Strogatz D, Seguin RA. Cost-effectiveness of a community-based cardiovascular disease prevention intervention in medically underserved rural areas. BMC Health Serv Res. 2019 May 16;19(1):315. doi: 10.1186/s12913-019-4117-y.
Results Reference
derived
PubMed Identifier
29634086
Citation
Seguin RA, Paul L, Folta SC, Nelson ME, Strogatz D, Graham ML, Diffenderfer A, Eldridge G, Parry SA. Strong Hearts, Healthy Communities: A Community-Based Randomized Trial for Rural Women. Obesity (Silver Spring). 2018 May;26(5):845-853. doi: 10.1002/oby.22158. Epub 2018 Apr 10.
Results Reference
derived
PubMed Identifier
27066824
Citation
Morgan EH, Graham ML, Folta SC, Seguin RA. A qualitative study of factors related to cardiometabolic risk in rural men. BMC Public Health. 2016 Apr 11;16:305. doi: 10.1186/s12889-016-2977-1.
Results Reference
derived
PubMed Identifier
26822982
Citation
Seguin RA, Eldridge G, Graham ML, Folta SC, Nelson ME, Strogatz D. Strong Hearts, healthy communities: a rural community-based cardiovascular disease prevention program. BMC Public Health. 2016 Jan 28;16:86. doi: 10.1186/s12889-016-2751-4.
Results Reference
derived
Learn more about this trial
Strong Hearts: Rural CVD Prevention
We'll reach out to this number within 24 hrs