Randomized Trial of Dietary Intervention Therapy in Obese Hypertensives (DITOH)

NCT ID: NCT00000515

Last Updated: 2013-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1984-07-31
• Study Completion Date: 1992-09-30

Brief Summary

To determine the effects on blood pressure of dietary intervention, restricting caloric intake to 600 calories per day for 16 weeks compared to a control diet of 1200 calories per day in obese hypertensives. Secondary aims included a study of psychological characteristics at baseline and during the weight loss and maintenance phases of the study.

Detailed Description

BACKGROUND:

Hypertension is a highly prevalent disorder contributing to a large proportion of cardiovascular morbidity and mortality in the United States. Although drug therapy of elevated blood pressure can reduce the risks of cardiovascular morbidity and mortality, such therapy constitutes significant expense for individuals over long periods of time as well as large national expenditures. In addition, the side effects of drug therapy may be significant. DITOH would provide much needed information concerning the effects of various means of weight reduction on blood pressure as possible definitive therapy for hypertension or as an approach which could be combined with reduced drug dosages.

DESIGN NARRATIVE:

Randomized. After three weeks on a control diet, subjects were randomized to the Protein Sparing Modified Fast Diet which provided 600 calories per day (1.5 grams per kilogram of ideal body weight of high quality protein plus 19 grams of fat) or to a 1200 calorie per day Balanced Deficit Diet. After 16 weeks in the weight-loss phase, subjects entered the maintenance program for 20 weeks. Both diets were supplemented with vitamins, minerals, and fluids. The Protein Sparing Modified Fast Diet was supplemented with 5 grams of salt given as bouillon to equal the salt intake of the Balanced Deficit Diet. Patients were followed for 24 months after the end of the weight loss phase. The primary endpoint was change in diastolic blood pressure. Individuals who continued to have diastolic pressures above 104 mm Hg following the initial 16 week treatment period were treated with antihypertensive drugs.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION

Interventions

diet, reducing

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Men and women, ages 25 to 55. Subjects were obese, weighing between 130 and 210 percent of ideal body weight. Subjects had diastolic blood pressures between 90 and 105 mm Hg and were not on antihypertensive medications.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Principal Investigators

George Blackburn

Role:

Beth Israel Deaconess Medical Center

Other Identifiers

R01HL031989-06A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

34

Identifier Type: -

Identifier Source: org_study_id