NCT02707432

Brief Summary

The study will determine the feasibility and efficacy of adapting an evidence-based intervention (EBI) to reduce cardiovascular disease (CVD) risk factors in rural African American communities and determine the acceptability of mobile technology in these communities to support behavior change.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

2 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

March 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

March 27, 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
1.1 years until next milestone

Results Posted

Study results publicly available

April 9, 2020

Completed
Last Updated

April 9, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

March 9, 2016

Results QC Date

February 26, 2020

Last Update Submit

March 30, 2020

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular DiseasesCommunity-Based Participatory ResearchAfrican Americans

Outcome Measures

Primary Outcomes (1)

  • Change in Weight

    Measured in pounds

    Baseline and 6 months after initiated treatment

Secondary Outcomes (2)

  • Change in Systolic Blood Pressure

    Baseline, Month 6

  • Change in Diastolic Blood Pressure

    Baseline, Month 6

Study Arms (2)

Time 1 (T1) Intervention Group

EXPERIMENTAL

This group will be the first to receive the adapted intervention, "Heart Matters" (adapted from the PREMIER intervention). The intervention will be 12 months long.

Behavioral: Heart Matters

Time 2 (T2) Intervention Group

EXPERIMENTAL

This delayed intervention group will receive the adapted intervention, "Heart Matters," six months after the T1 Intervention group. The intervention will be 12 months long.

Behavioral: Heart Matters

Interventions

Heart MattersBEHAVIORAL

"Heart Matters" is an intervention adapted from PREMIER, an evidence-based, comprehensive lifestyle intervention that focuses on blood pressure as the primary outcome. To assess the feasibility and efficacy of adapting PREMIER for rural African Americans, Heart Matters will be delivered to multiple intervention groups, but at two different stages.

Also known as: PREMIER
Time 1 (T1) Intervention GroupTime 2 (T2) Intervention Group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American
  • Aged 21 and older
  • Has at least one of the following cardiovascular disease (CVD) risk factors: pre-diabetes, hypertension, obesity, family history of early CVD, prior CVD
  • Reside in Nash or Edgecombe counties of North Carolina

You may not qualify if:

  • Evidence of active or unstable CVD
  • Cognitive impairment that limits informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Project Momentum Inc.

Rocky Mount, North Carolina, 27801, United States

Location

Shirley McFarlin

Rocky Mount, North Carolina, 27891, United States

Location

Related Publications (2)

  • Frerichs L, Bess K, Young TL, Hoover SM, Calancie L, Wynn M, McFarlin S, Cene CW, Dave G, Corbie-Smith G. A Cluster Randomized Trial of a Community-Based Intervention Among African-American Adults: Effects on Dietary and Physical Activity Outcomes. Prev Sci. 2020 Apr;21(3):344-354. doi: 10.1007/s11121-019-01067-5.

    PMID: 31925605DERIVED

  • Corbie-Smith G, Wiley-Cene C, Bess K, Young T, Dave G, Ellis K, Hoover SM, Lin FC, Wynn M, McFarlin S, Ede J. Heart Matters: a study protocol for a community based randomized trial aimed at reducing cardiovascular risk in a rural, African American community. BMC Public Health. 2018 Jul 31;18(1):938. doi: 10.1186/s12889-018-5802-1.

    PMID: 30064398DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Permadyne Premier

Results Point of Contact

Title
Stephanie Hoover, PhD
Organization
University of North Carolina at Chapel Hill
stephanie_hoover@med.unc.edu
919-966-1649

Study Officials

  • Giselle Corbie-Smith, MD, MSc

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Mysha Wynn, MA

    Project Momentum, Inc.

    PRINCIPAL INVESTIGATOR

  • Shirley McFarlin, BA

    James McFarlin Community Development, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 14, 2016

Study Start

March 27, 2017

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

April 9, 2020

Results First Posted

April 9, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)