Grenada Heart Project - GHP-CHANGE

Contribution To Literature:

The GHP-CHANGE trial failed to show that an intervention program was superior to control at improving cardiovascular risk factors.

Description:

The goal of the trial was to evaluate an intervention program compared with control among individuals at risk of cardiovascular disease.

Study Design

  • Randomized
  • Parallel

Healthy individuals at risk of cardiovascular disease were randomized to an intervention program (n = 206) versus control (n = 193). The intervention program consisted of training workshops and peer group dynamics to motivate change and increase physical activity, healthy diet, and improve rates of smoking cessation, stress management, and self-control of blood pressure (BP).

  • Total number of enrollees: 399
  • Duration of follow-up: 12 months
  • Mean patient age: 51 years
  • Percentage female: 65%
  • Percentage with diabetes: 16%

Inclusion criteria:

  • Residents of Grenada with at least two of the following risk factors:
  1. Systolic BP 120-159 mm Hg (or diastolic BP 80-89 mm Hg)
  2. Exercise <120 minutes per week
  3. Waist circumference >40 inches (>35 inches for women)
  4. Less than two servings of fruit/vegetable per day
  5. Daily smoking
  6. Fasting glucose >100 mg/dl
  7. Total cholesterol >250 mg/dl, low-density lipoprotein cholesterol >130 mg/dl

Note: Inclusion criteria 1-5 comprise the Fuster BEWAT score.

Exclusion criteria:

  • Age <18 years or >70 years
  • Inability of self-monitoring
  • Pregnancy
  • Limited life expectancy

Principal Findings:

The primary outcome, difference in Fuster BEWAT score at 1 year, was 0.4 in the intervention group versus 0.12 in the control group (p-value between groups = 0.59).

Interpretation:

Among individuals at risk of cardiovascular disease, an intervention program failed to improve cardiovascular risk factors more than control. Modest improvements in cardiovascular risk factors occurred in both treatment groups. Behavioral programs aimed at risk factor modification remain challenging.

References:

Presented by Dr. Sameer Bansilal at the American Heart Association Annual Scientific Sessions (AHA 2016), New Orleans, LA, November 14, 2016.

Clinical Topics: Acute Coronary Syndromes, Diabetes and Cardiometabolic Disease, Clinical Topic Collection: Dyslipidemia, Prevention, Lipid Metabolism, Nonstatins, Diet, Exercise

Keywords: AHA Annual Scientific Sessions, Acute Coronary Syndrome, Blood Pressure, Cardiovascular Diseases, Cholesterol, Consumer Participation, Diet, Exercise, Grenada, Health Behavior, Primary Prevention, Residence Characteristics, Risk Factors, Smoking Cessation


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