Strong Hearts: Rural CVD Prevention
Strong Hearts, Healthy Communities: A Rural Community CVD Prevention Program
1 other identifier
interventional
194
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2020
CompletedApril 17, 2020
April 1, 2020
2.3 years
July 1, 2015
April 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in body weight
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Secondary Outcomes (13)
Changes in blood pressure
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Changes in lipids
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Changes in c-reactive protein
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Changes in hemoglobin A1C
Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Changes in waist circumference
Baseline to 3 months, 6 months, 6-month follow-up, and 18-month follow-up
- +8 more secondary outcomes
Study Arms (2)
Strong Hearts, Healthy Communities
EXPERIMENTALFull 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
EXPERIMENTALStrong 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.
Interventions
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".
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cornell Universitylead
- Montana State Universitycollaborator
- Tufts Universitycollaborator
- Bassett Healthcarecollaborator
Study Sites (16)
Broadus
Broadus, Montana, 59317, United States
Chinook
Chinook, Montana, 59523, United States
Choteau
Choteau, Montana, 59422, United States
Columbus
Columbus, Montana, 59019, United States
Forsyth
Forsyth, Montana, 59327, United States
Glasgow
Glasgow, Montana, 59230, United States
Harlowton
Harlowton, Montana, 59036, United States
Hinsdale
Hinsdale, Montana, 59241, United States
Lewistown
Lewistown, Montana, 59457, United States
Plentywood
Plentywood, Montana, 59254, United States
Shelby
Shelby, Montana, 59474, United States
Thompson Falls
Thompson Falls, Montana, 59873, United States
Cherry Valley
Cherry Valley, New York, 13320, United States
Little Falls
Little Falls, New York, 13365, United States
St. Johnsville
Saint Johnsville, New York, 13452, United States
Sidney
Sidney, New York, 13838, United States
Related Publications (6)
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.
PMID: 31718657DERIVEDFolta 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.
PMID: 31653260DERIVEDWang 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.
PMID: 31096977DERIVEDSeguin 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.
PMID: 29634086DERIVEDMorgan 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.
PMID: 27066824DERIVEDSeguin 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.
PMID: 26822982DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Seguin, PhD
Cornell University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2015
First Posted
July 16, 2015
Study Start
March 1, 2014
Primary Completion
June 1, 2016
Study Completion
February 15, 2020
Last Updated
April 17, 2020
Record last verified: 2020-04