Strong Hearts: Rural CVD Prevention

• Sponsor: Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02499731
• Collaborator: Montana State University (Other), Tufts University (Other), Bassett Healthcare (Other)
• Enrollment: 194
• Locations: 16
• Arms: 2
• Duration (Months): 71.5
• Patients Per Site: 12.1
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Disease; Cardiovascular Disease; Sedentary Lifestyle; Overweight; Obesity	Behavioral: Strong Hearts, Healthy Communities; Behavioral: Strong Hearts, Healthy Women	N/A

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 Design

• Study Type: Interventional
• 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: Mar 1, 2014
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Feb 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in body weight [Baseline to 6 months, 6-month follow-up, and 18-month follow-up]

Secondary Outcome Measures

1. Changes in blood pressure [Baseline to 6 months, 6-month follow-up, and 18-month follow-up]

2. Changes in lipids [Baseline to 6 months, 6-month follow-up, and 18-month follow-up]

3. Changes in c-reactive protein [Baseline to 6 months, 6-month follow-up, and 18-month follow-up]

4. Changes in hemoglobin A1C [Baseline to 6 months, 6-month follow-up, and 18-month follow-up]

5. Changes in waist circumference [Baseline to 3 months, 6 months, 6-month follow-up, and 18-month follow-up]

6. Changes in 7-day accelerometry [Baseline to 6 months, 6-month follow-up, and 18-month follow-up]

7. Changes in 7-day dietary recall [Baseline to 6 months, 6-month follow-up, and 18-month follow-up]

8. Changes in healthy eating self-efficacy assessed by questionnaire [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 [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 [Baseline to 6 months and 6-month follow-up]

11. Changes in exercise attitudes of social network of participants assessed by questionnaire [Baseline to 6 months and 6-month follow-up]

12. Changes in healthy eating self-efficacy of social network of participants assessed by questionnaire [Baseline to 6 months and 6-month follow-up]

13. Changes in exercise self-efficacy of social network of participants assessed by questionnaire [Baseline to 6 months and 6-month follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Broadus	Broadus	Montana	United States	59317
2	Chinook	Chinook	Montana	United States	59523
3	Choteau	Choteau	Montana	United States	59422
4	Columbus	Columbus	Montana	United States	59019
5	Forsyth	Forsyth	Montana	United States	59327
6	Glasgow	Glasgow	Montana	United States	59230
7	Harlowton	Harlowton	Montana	United States	59036
8	Hinsdale	Hinsdale	Montana	United States	59241
9	Lewistown	Lewistown	Montana	United States	59457
10	Plentywood	Plentywood	Montana	United States	59254
11	Shelby	Shelby	Montana	United States	59474
12	Thompson Falls	Thompson Falls	Montana	United States	59873
13	Cherry Valley	Cherry Valley	New York	United States	13320
14	Little Falls	Little Falls	New York	United States	13365
15	St. Johnsville	Saint Johnsville	New York	United States	13452
16	Sidney	Sidney	New York	United States	13838

Sponsors and Collaborators

• Cornell University
• Montana State University
• Tufts University
• Bassett Healthcare

Investigators

• Principal Investigator: Rebecca Seguin, PhD, Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cornell University
• ClinicalTrials.gov Identifier: NCT02499731
• Other Study ID Numbers: IRB #: 1402004505
• First Posted: Jul 16, 2015
• Last Update Posted: Apr 17, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by Cornell University: physical activity; nutrition; social network
• Additional relevant MeSH terms: Cardiovascular Diseases; Heart Diseases; Overweight

Study Results

No Results Posted as of Apr 17, 2020