Overview

This trial is active, not recruiting.

Conditions heart disease, cardiovascular disease, sedentary lifestyle, overweight, obesity
Treatments strong hearts, healthy communities, strong hearts, healthy women
Sponsor Cornell University
Collaborator Montana State University
Start date March 2014
End date June 2016
Trial size 194 participants
Trial identifier NCT02499731, IRB #: 1402004505

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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 communities Strong Hearts for Montana
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".
(Experimental)
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.
strong hearts, healthy women Strong Hearts for Montana
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 Outcomes

Measure
Change in body weight
time frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up

Secondary Outcomes

Measure
Changes in blood pressure
time frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Changes in lipids
time frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Changes in c-reactive protein
time frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Changes in hemoglobin A1C
time frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Changes in waist circumference
time frame: Baseline to 3 months, 6 months, 6-month follow-up, and 18-month follow-up
Changes in 7-day accelerometry
time frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Changes in 7-day dietary recall
time frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
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
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
Changes in healthy eating attitudes of social network of participants assessed by questionnaire
time frame: Baseline to 6 months and 6-month follow-up
Changes in exercise attitudes of social network of participants assessed by questionnaire
time frame: Baseline to 6 months and 6-month follow-up
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
Changes in exercise self-efficacy of social network of participants assessed by questionnaire
time frame: Baseline to 6 months and 6-month follow-up

Eligibility Criteria

Female participants at least 40 years old.

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

Additional Information

Official title Strong Hearts, Healthy Communities: A Rural Community CVD Prevention Program
Principal investigator Rebecca Seguin, PhD
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".
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Cornell University.