Grenada Heart Project - Community Health Action to Encourage Healthy Behaviors

NCT02428920 | Completed Phase 3

• 1 other identifier: GCO 12-2004
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The Grenada Heart Project (GHP) conducted an observational study within a randomly selected adult sample of Grenadians in 2008-2009. The aim of the study was to assess the clinical, biological and psychosocial determinants of the cardiovascular health in Grenada, in order to develop and implement a nationwide cardiovascular health promotion program. The sample of 2,827 adults was randomly selected from the national electronic voter list. The main outcome measures were self-reported cardiovascular disease and behavioral risk factors, anthropometric measures, blood pressure (BP), point-of-care testing for glucose and lipids, and ankle-brachial index. Analysis of the data revealed prevalence rates of obesity, hypertension and diabetes significantly exceeding those seen in the U.S. Since the completion of this assessment, an additional effort has contributed significantly to the current project. A parallel community health-promotion project was carried out in Cardona, Spain called the "Cardona Integral Fifty-Fifty" project with 80 subjects. The preliminary results of the Cardona study have a shown that peer motivation may significantly improve healthy behaviors and thus modify cardiovascular risk. The GHP CHANGE community -based intervention aims to promote positive behaviors and focus more on what creates health, rather than what prevents sickness. It is built on the foundations of social support, assessing whether people going through similar challenges will support each other, work together to identify and address barriers to success, and motivate each other to move forward. In this program we test for the impact of promotion of healthy lifestyle behaviors through peer motivation on blood pressure, physical activity, eating behavior, weight, and smoking.

Conditions

Health Behavior

Keywords

cardiovascular health; behavior change; community-based; prevention

Outcome Measures

Primary Outcomes (3)

• Composite GHP outcomes health score

  The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.

  baseline

• Composite GHP outcomes health score

  The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.

  6 months

• Composite GHP outcomes health score

  The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.

  12 months

Secondary Outcomes (3)

• Change in blood pressure

  baseline and 12 months

• Change in body weight

  baseline and 12 months

• Change in behavior

  baseline and 12 months

Study Arms (2)

Peer Groups

EXPERIMENTAL

Individuals in Intervention Group Arm will attend biweekly or monthly peer support groups (approximately 10 people per group) for evaluating changes and promoting mutual support. 12-month duration.

Behavioral: Peer Groups

Control Arm

NO INTERVENTION

The control arm, will attend the initial educational group lectures at baseline assessment and will receive no intervention thereafter.

Interventions

Peer Groups BEHAVIORAL

The intervention group arm will attend biweekly or monthly peer group meetings to discuss health successes and challenges.

Peer Groups

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resident of Grenada
• One or more vascular risk factors:
• Borderline to elevated blood pressure (defined as systolic blood pressure ≥120 mm Hg to SBP \< 160 or diastolic blood pressure ≥ 80 and \< 90 mm Hg)
• Waist circumference of \>40 inches for men and \>35 inches for women
• Smoking (active self-reported smoking, of any type of tobacco, at least daily)
• Physical inactivity (reporting less than 120 min/week of activity)
• Fasting glucose level \> 100 mg/dl
• Total Cholesterol \>250 mg/dl, LDL \> 130 mg/dl
• Fruit/vegetable intake less than 2 servings daily

You may not qualify if:

• Unable/unwilling to provide consent
• Age of under 18 or more than 70 years old (inclusive) as of December 2012
• Inability of self-monitoring
• Pregnant women
• Morbidly ill with expectation of death within a year

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• St. George's University: collaborator

Study Sites (1)

St. George's University

Saint George's, Grenada

Location

Related Publications (1)

• Latina J, Fernandez-Jimenez R, Bansilal S, Sartori S, Vedanthan R, Lewis M, Kofler C, Hunn M, Martin F, Bagiella E, Farkouh M, Fuster V. Grenada Heart Project-Community Health ActioN to EncouraGe healthy BEhaviors (GHP-CHANGE): A randomized control peer group-based lifestyle intervention. Am Heart J. 2020 Feb;220:20-28. doi: 10.1016/j.ahj.2019.08.022. Epub 2019 Sep 4.

  PMID: 31765932 DERIVED

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Valentin Fuster, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Mount Sinai Heart

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: April 29, 2015
• Study Start: July 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 8, 2016

Record last verified: 2016-09

Locations

GR (1)