NCT03059472

Brief Summary

Strong Hearts for New York 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. Our aim is to better understand how changes in lifestyle can affect the health of rural women and others in their communities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 31, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

January 5, 2022

Status Verified

January 1, 2022

Enrollment Period

1.9 years

First QC Date

February 13, 2017

Last Update Submit

January 3, 2022

Conditions

Heart DiseaseCardiovascular DiseaseSedentary LifestyleOverweightObesity

Keywords

physical activitynutritionsocial networkcivic engagement

Outcome Measures

Primary Outcomes (1)

  • Change in body weight

    Baseline to 24 weeks

Secondary Outcomes (15)

  • Changes in body weight

    Baseline to 48 weeks

  • Changes in blood pressure

    Baseline to 24 weeks, 48 weeks

  • Changes in blood lipids

    Baseline to 24 weeks, 48 weeks

  • Changes in c-reactive protein

    Baseline to 24 weeks, 48 weeks

  • Changes in hemoglobin A1C

    Baseline to 24 weeks, 48 weeks

  • +10 more secondary outcomes

Study Arms (2)

Group 1 (Intervention)

EXPERIMENTAL

Full Intervention participants will meet twice per week for one hour each time, for approximately 6 months. Participants will learn and practice good nutrition and physical activity for improved individual, family and community health.

Behavioral: Group 1 (Intervention)

Group 2 (Delayed intervention)

EXPERIMENTAL

Delayed intervention participants will participate in the same activities as Group 1 but 6 months after Group 1.

Behavioral: Group 2 (Delayed intervention)

Interventions

Group 1 (Intervention)BEHAVIORAL

The investigators will evaluate the efficacy of the SHHC curriculum in a 24-week community-based randomized delayed intervention trial. They will compare changes in CVD-related anthropometric, physiologic, behavioral, and psychosocial parameters between subjects in 5 intervention and 6 delayed intervention communities. In addition, the investigators will evaluate changes in behavior, attitudes, and knowledge among SHHC intervention subjects' "social network".

Group 1 (Intervention)
Group 2 (Delayed intervention)BEHAVIORAL

The investigators will evaluate the efficacy of the SHHC curriculum in a 24-week community-based randomized delayed intervention trial. They will compare changes in CVD-related anthropometric, physiologic, behavioral, and psychosocial parameters between subjects in 5 intervention and 6 delayed intervention communities. In addition, the investigators will evaluate changes in behavior, attitudes, and knowledge among SHHC intervention subjects' "social network".

Group 2 (Delayed intervention)

Eligibility Criteria

Age40 Years - 99 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index (BMI) greater than or equal to 25
  • If BMI is less than 30, not currently physically active
  • 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 intervention starting either in March 2017 or September 2017
  • Willing to participate in assessment activities
  • Willing to make a firm commitment to participate in intervention starting either in Spring or Fall 2017

You may not qualify if:

  • BMI less than 25
  • If BMI is less than 30, currently physically active
  • 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 intervention starting either in Spring or Fall 2017

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Clyde

Clyde, New York, 14433, United States

Location

Cobleskill

Cobleskill, New York, 12043, United States

Location

Cooperstown

Cooperstown, New York, 13326, United States

Location

Dolgeville and Little Falls

Dolgeville, New York, 13329, United States

Location

Hamilton

Hamilton, New York, 13346, United States

Location

Hartwick

Hartwick, New York, 13348, United States

Location

Herkimer, Mohawk and Ilion

Herkimer, New York, 13350, United States

Location

Ithaca

Ithaca, New York, 14853, United States

Location

Seguin Research Lab, Cornell University

Ithaca, New York, 14853, United States

Location

Milford

Milford, New York, 13807, United States

Location

Morrisville

Morrisville, New York, 13408, United States

Location

Newark

Newark, New York, 14513, United States

Location

Sharon Springs

Sharon Springs, New York, 13459, United States

Location

Related Publications (7)

  • Andreyeva E, Graham ML, Eldridge GD, Folta SC, Nelson ME, Strogatz D, Seguin-Fowler RA. Cost-Effectiveness of Two Iterations of a Community-Based Cardiovascular Disease Prevention Intervention. Obesity (Silver Spring). 2026 Jan;34(1):65-75. doi: 10.1002/oby.70050. Epub 2025 Oct 16.

    PMID: 41102867DERIVED

  • Szeszulski J, Rolke LJ, Ayine P, Bailey R, Demment M, Eldridge GD, Folta SC, Graham ML, MacMillan Uribe AL, McNeely A, Nelson ME, Pullyblank K, Rethorst C, Strogatz D, Seguin-Fowler RA. Process evaluation findings from Strong Hearts, Healthy Communities 2.0: a cardiovascular disease prevention intervention for rural women. Int J Behav Nutr Phys Act. 2024 Oct 22;21(1):122. doi: 10.1186/s12966-024-01670-y.

    PMID: 39438920DERIVED

  • MacMillan Uribe AL, Demment M, Graham ML, Szeszulski J, Rethorst CD, Githinji P, Nelson ME, Strogatz D, Folta SC, Bailey RL, Davis JN, Seguin-Fowler RA. Improvements in dietary intake, behaviors, and psychosocial measures in a community-randomized cardiovascular disease risk reduction intervention: Strong Hearts, Healthy Communities 2.0. Am J Clin Nutr. 2023 Nov;118(5):1055-1066. doi: 10.1016/j.ajcnut.2023.09.003. Epub 2023 Sep 17.

    PMID: 37717638DERIVED

  • Maddock JE, Demment M, Graham M, Folta S, Strogatz D, Nelson M, Ha SY, Eldridge GD, Seguin-Fowler RA. Changes in physical activity outcomes in the Strong Hearts, Healthy Communities (SHHC-2.0) community-based randomized trial. Int J Behav Nutr Phys Act. 2022 Dec 28;19(1):159. doi: 10.1186/s12966-022-01401-1.

    PMID: 36578002DERIVED

  • Seguin-Fowler RA, Eldridge GD, Rethorst CD, Graham ML, Demment M, Strogatz D, Folta SC, Maddock JE, Nelson ME, Ha S. Improvements and Maintenance of Clinical and Functional Measures Among Rural Women: Strong Hearts, Healthy Communities-2. 0 Cluster Randomized Trial. Circ Cardiovasc Qual Outcomes. 2022 Nov;15(11):e009333. doi: 10.1161/CIRCOUTCOMES.122.009333. Epub 2022 Nov 15.

    PMID: 36378768DERIVED

  • Seguin-Fowler RA, Strogatz D, Graham ML, Eldridge GD, Marshall GA, Folta SC, Pullyblank K, Nelson ME, Paul L. The Strong Hearts, Healthy Communities Program 2.0: An RCT Examining Effects on Simple 7. Am J Prev Med. 2020 Jul;59(1):32-40. doi: 10.1016/j.amepre.2020.01.027. Epub 2020 May 7.

    PMID: 32389532DERIVED

  • Pullyblank K, Strogatz D, Folta SC, Paul L, Nelson ME, Graham M, Marshall GA, Eldridge G, Parry SA, Mebust S, Seguin RA. Effects of the Strong Hearts, Healthy Communities Intervention on Functional Fitness of Rural Women. J Rural Health. 2020 Jan;36(1):104-110. doi: 10.1111/jrh.12361. Epub 2019 Mar 13.

    PMID: 30865324DERIVED

MeSH Terms

Conditions

Heart DiseasesCardiovascular DiseasesSedentary BehaviorOverweightObesityMotor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Rebecca Seguin, PhD

    Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 23, 2017

Study Start

March 31, 2017

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

January 5, 2022

Record last verified: 2022-01

Locations

US(13)