Hypertension Clinical Trial
To evaluate the long-term effect of reduction of alcohol intake on blood pressure in moderate but non-dependent drinkers with mild hypertension or high normal blood pressure.
BACKGROUND:
Numerous observational epidemiologic studies have established ethanol intake as one of the
most important determinants of blood pressure levels. However, data from intervention
studies were very limited.
The study was an inter-agency agreement involving the Veterans Administration and the
National Institute on Alcohol Abuse and Alcoholism (NIAAA). Protocol development occurred
between October 1988 and June 1989. The protocol was approved by the VA Cooperative Studies
Evaluation Committee in July 1989 and reviewed by a separate Data and Safety Monitoring
Board in September 1989.
DESIGN NARRATIVE:
Subjects were randomized to intervention or control groups. Intervention aimed to reduce
alcohol intake to no more than 14 drinks per week and 50 percent or less of each
participant's baseline level. The intervention technique consisted of a cognitive-behavioral
program, the intensive phase of which consisted of six counseling sessions over three
months. Echocardiograms were obtained at baseline and six months after randomization.
Biochemical markers were used to validate changes in alcohol consumption. The trial included
an eighteen-month feasibility phase with six-month follow-up and a 36-month main trial with
two years of follow-up. Recruitment for the full-scale trial ended in June 1993. Final study
visits were conducted in September and October 1994.
The study completion date listed in this record was obtained from the "End Date" entered in
the Query View Report System (QVR).
;
Allocation: Randomized, Primary Purpose: Prevention
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