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Heart DiseaseNCT02499731

Strong Hearts: Rural CVD Prevention

A study testing Strong Hearts, Healthy Communities and Strong Hearts, Healthy Women in people with Heart Disease and Cardiovascular Disease, run by Cornell University at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and older, women only
What is being tested?
Strong Hearts, Healthy Communities and Strong Hearts, Healthy Women
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
16 sitesUnited States
Study dates
Mar 2014to 15 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Broadus

    Broadus, Montana, 59317

  • Cherry Valley

    Cherry Valley, New York, 13320

  • Chinook

    Chinook, Montana, 59523

  • Choteau

    Choteau, Montana, 59422

  • Columbus

    Columbus, Montana, 59019

  • Forsyth

    Forsyth, Montana, 59327

  • Glasgow

    Glasgow, Montana, 59230

  • Harlowton

    Harlowton, Montana, 59036

  • Hinsdale

    Hinsdale, Montana, 59241

  • Lewistown

    Lewistown, Montana, 59457

  • Little Falls

    Little Falls, New York, 13365

  • Plentywood

    Plentywood, Montana, 59254

  • St. Johnsville

    Saint Johnsville, New York, 13452

  • Shelby

    Shelby, Montana, 59474

  • Sidney

    Sidney, New York, 13838

  • Thompson Falls

    Thompson Falls, Montana, 59873

Other trials in United States

About this study

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

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.

Read the 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".

Being tested
Strong Hearts, Healthy Communities, Strong Hearts, Healthy Women
Keywords
physical activity, nutrition, social network
Medical subject headings
Heart Diseases, Cardiovascular Diseases, Sedentary Behavior, Overweight, Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Strong Hearts, Healthy CommunitiesBehavioural

    Also called Strong Hearts for Montana, Full intervention

    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 WomenBehavioural

    Also called Strong Hearts for Montana, Minimal intervention

    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.

Study groups in NCT02499731
Study groupRoleWhat they receive
Strong Hearts, Healthy CommunitiesExperimentalFull 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.
Receives: Behavioral: Strong Hearts, Healthy Communities
Strong Hearts, Healthy WomenExperimentalStrong 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.
Receives: Behavioral: Strong Hearts, Healthy Women

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body weight

    Measured: Baseline to 6 months, 6-month follow-up, and 18-month follow-up

Secondary outcomes (13)

  1. Changes in blood pressure

    Measured: Baseline to 6 months, 6-month follow-up, and 18-month follow-up

  2. Changes in lipids

    Measured: Baseline to 6 months, 6-month follow-up, and 18-month follow-up

  3. Changes in c-reactive protein

    Measured: Baseline to 6 months, 6-month follow-up, and 18-month follow-up

  4. Changes in hemoglobin A1C

    Measured: Baseline to 6 months, 6-month follow-up, and 18-month follow-up

  5. Changes in waist circumference

    Measured: Baseline to 3 months, 6 months, 6-month follow-up, and 18-month follow-up

  6. Changes in 7-day accelerometry

    Measured: Baseline to 6 months, 6-month follow-up, and 18-month follow-up

  7. Changes in 7-day dietary recall

    Measured: Baseline to 6 months, 6-month follow-up, and 18-month follow-up

  8. Changes in healthy eating self-efficacy assessed by questionnaire

    Measured: 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

    Measured: 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

    Measured: Baseline to 6 months and 6-month follow-up

  11. Changes in exercise attitudes of social network of participants assessed by questionnaire

    Measured: Baseline to 6 months and 6-month follow-up

  12. Changes in healthy eating self-efficacy of social network of participants assessed by questionnaire

    Measured: Baseline to 6 months and 6-month follow-up

  13. Changes in exercise self-efficacy of social network of participants assessed by questionnaire

    Measured: Baseline to 6 months and 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2015 (estimated)
  2. Study startMar 2014
  3. Primary completionJun 2016
  4. Study completion15 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02499731
Sponsor's protocol ID
IRB #: 1402004505
Status last verified
Apr 2020
First submitted
1 Jul 2015
Last updated
17 Apr 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31718657

  • 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.

    PubMed 31653260

  • 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.

    PubMed 31096977

  • 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.

    PubMed 29634086

  • 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.

    PubMed 27066824

  • 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.

    PubMed 26822982

Questions about this trial

What is this clinical trial studying?

A study testing Strong Hearts, Healthy Communities and Strong Hearts, Healthy Women in people with Heart Disease and Cardiovascular Disease, run by Cornell University at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body weight (time frame: Baseline to 6 months, 6-month follow-up, and 18-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02499731, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.

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