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Grenada Heart Project - Community Health Action to Encourage Healthy Behaviors (GHP CHANGE)

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ClinicalTrials.gov Identifier: NCT02428920
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : September 8, 2016
Sponsor:
Collaborator:
St. George's University
Information provided by (Responsible Party):
Valentin Fuster, Icahn School of Medicine at Mount Sinai

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.


Condition or disease Intervention/treatment Phase
Health Behavior Behavioral: Peer Groups Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Grenada Heart Project - Community Health Action to Encourage Healthy Behaviors
Study Start Date : July 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: Peer Groups
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
The intervention group arm will attend biweekly or monthly peer group meetings to discuss health successes and challenges.

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



Primary Outcome Measures :
  1. Composite GHP outcomes health score [ Time Frame: baseline ]
    The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.

  2. Composite GHP outcomes health score [ Time Frame: 6 months ]
    The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.

  3. Composite GHP outcomes health score [ Time Frame: 12 months ]
    The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.


Secondary Outcome Measures :
  1. Change in blood pressure [ Time Frame: baseline and 12 months ]
    Change in blood pressure at 12 months as compared to baseline

  2. Change in body weight [ Time Frame: baseline and 12 months ]
    Change in body weight at 12 months as compared to baseline

  3. Change in behavior [ Time Frame: baseline and 12 months ]
    Change in behavior as 12 months as compared to baseline



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428920


Locations
Grenada
St. George's University
St. George's, Grenada
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
St. George's University
Investigators
Principal Investigator: Valentin Fuster, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Valentin Fuster, Director, Mount Sinai Heart, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02428920     History of Changes
Other Study ID Numbers: GCO 12-2004
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016

Keywords provided by Valentin Fuster, Icahn School of Medicine at Mount Sinai:
cardiovascular health
behavior change
community-based
prevention