Clinical trial NCT02499731: Strong Hearts: Rural CVD Prevention
Official title: Strong Hearts, Healthy Communities: A Rural Community CVD Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Disease
Cardiovascular Disease
Sedentary Lifestyle
Overweight
Obesity
Keywords: physical activity
nutrition
social network
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: Montana State University
name: Tufts University
name: Bassett Healthcare
First posted: 2015-07-16
Enrollment: 194
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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".

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

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
Secondary outcomes:
measure: Changes in blood pressure
timeFrame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
measure: Changes in lipids
timeFrame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
measure: Changes in c-reactive protein
timeFrame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
measure: Changes in hemoglobin A1C
timeFrame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
measure: Changes in waist circumference
timeFrame: Baseline to 3 months, 6 months, 6-month follow-up, and 18-month follow-up
measure: Changes in 7-day accelerometry
timeFrame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
measure: Changes in 7-day dietary recall
timeFrame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up
measure: Changes in healthy eating self-efficacy assessed by questionnaire
timeFrame: Baseline to 3 months, 6 months, 6-month follow-up, one-year follow-up, and 18-month follow-up
measure: Changes in exercise self-efficacy assessed by questionnaire
timeFrame: Baseline to 3 months, 6 months, 6-month follow-up, one-year follow-up, and 18-month follow-up
measure: Changes in healthy eating attitudes of social network of participants assessed by questionnaire
timeFrame: Baseline to 6 months and 6-month follow-up
measure: Changes in exercise attitudes of social network of participants assessed by questionnaire
timeFrame: Baseline to 6 months and 6-month follow-up
measure: Changes in healthy eating self-efficacy of social network of participants assessed by questionnaire
timeFrame: Baseline to 6 months and 6-month follow-up
measure: Changes in exercise self-efficacy of social network of participants assessed by questionnaire
timeFrame: Baseline to 6 months and 6-month follow-up
Other outcomes:
Locations:
city: Broadus
country: United States
facility: Broadus
state: Montana
city: Chinook
country: United States
facility: Chinook
state: Montana
city: Choteau
country: United States
facility: Choteau
state: Montana
city: Columbus
country: United States
facility: Columbus
state: Montana
city: Forsyth
country: United States
facility: Forsyth
state: Montana
city: Glasgow
country: United States
facility: Glasgow
state: Montana
city: Harlowton
country: United States
facility: Harlowton
state: Montana
city: Hinsdale
country: United States
facility: Hinsdale
state: Montana
city: Lewistown
country: United States
facility: Lewistown
state: Montana
city: Plentywood
country: United States
facility: Plentywood
state: Montana
city: Shelby
country: United States
facility: Shelby
state: Montana
city: Thompson Falls
country: United States
facility: Thompson Falls
state: Montana
city: Cherry Valley
country: United States
facility: Cherry Valley
state: New York
city: Little Falls
country: United States
facility: Little Falls
state: New York
city: Saint Johnsville
country: United States
facility: St. Johnsville
state: New York
city: Sidney
country: United States
facility: Sidney
state: New York
Study officials:
affiliation: Cornell University
name: Rebecca Seguin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.