Strong Hearts: Rural CVD Prevention

NCT ID: NCT02499731

Last Updated: 2020-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2020-02-15

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".

Conditions

Heart Disease; Cardiovascular Disease; Sedentary Lifestyle; Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Strong Hearts, Healthy Communities

Intervention Type: BEHAVIORAL

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".

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.

Group Type: EXPERIMENTAL

Strong Hearts, Healthy Women

Intervention Type: BEHAVIORAL

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.

Interventions

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".

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Strong Hearts for Montana; Full intervention; Strong Hearts for Montana; Minimal intervention

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Montana State University

OTHER

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: collaborator

Bassett Healthcare

OTHER

Sponsor Role: collaborator

Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Seguin, PhD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Locations

Broadus

Broadus, Montana, United States

Chinook

Chinook, Montana, United States

Choteau

Choteau, Montana, United States

Columbus

Columbus, Montana, United States

Forsyth

Forsyth, Montana, United States

Glasgow

Glasgow, Montana, United States

Harlowton

Harlowton, Montana, United States

Hinsdale

Hinsdale, Montana, United States

Lewistown

Lewistown, Montana, United States

Plentywood

Plentywood, Montana, United States

Shelby

Shelby, Montana, United States

Thompson Falls

Thompson Falls, Montana, United States

Cherry Valley

Cherry Valley, New York, United States

Little Falls

Little Falls, New York, United States

St. Johnsville

Saint Johnsville, New York, United States

Sidney

Sidney, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31718657 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31653260 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31096977 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29634086 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27066824 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26822982 (View on PubMed)

Other Identifiers

IRB #: 1402004505

Identifier Type: -

Identifier Source: org_study_id