Strong Hearts: Rural CVD Prevention

Obesity Clinical Trial

Official title:

Strong Hearts, Healthy Communities: A Rural Community CVD Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499731
• Other study ID #: IRB #: 1402004505
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: February 15, 2020

Study information

• Verified date: April 2020
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: February 15, 2020
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Heart Disease
• Heart Diseases
• Obesity
• Overweight
• Sedentary Lifestyle

Intervention

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".
• 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.

Locations

Country	Name	City	State
United States	Broadus	Broadus	Montana
United States	Cherry Valley	Cherry Valley	New York
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	Little Falls	Little Falls	New York
United States	Plentywood	Plentywood	Montana
United States	St. Johnsville	Saint Johnsville	New York
United States	Shelby	Shelby	Montana
United States	Sidney	Sidney	New York
United States	Thompson Falls	Thompson Falls	Montana

Sponsors (4)

Lead Sponsor	Collaborator
Cornell University	Bassett Healthcare, Montana State University, Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight		Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Secondary	Changes in blood pressure		Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Secondary	Changes in lipids		Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Secondary	Changes in c-reactive protein		Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Secondary	Changes in hemoglobin A1C		Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Secondary	Changes in waist circumference		Baseline to 3 months, 6 months, 6-month follow-up, and 18-month follow-up
Secondary	Changes in 7-day accelerometry		Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Secondary	Changes in 7-day dietary recall		Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Secondary	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
Secondary	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
Secondary	Changes in healthy eating attitudes of social network of participants assessed by questionnaire		Baseline to 6 months and 6-month follow-up
Secondary	Changes in exercise attitudes of social network of participants assessed by questionnaire		Baseline to 6 months and 6-month follow-up
Secondary	Changes in healthy eating self-efficacy of social network of participants assessed by questionnaire		Baseline to 6 months and 6-month follow-up
Secondary	Changes in exercise self-efficacy of social network of participants assessed by questionnaire		Baseline to 6 months and 6-month follow-up