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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000515
First Posted: October 28, 1999
Last Update Posted: November 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
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.

Condition Intervention Phase
Cardiovascular Diseases Heart Diseases Hypertension Obesity Behavioral: diet, reducing Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 1984
Study Completion Date: September 1992
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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): NCT00000515


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: George Blackburn Beth Israel Deaconess Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00000515     History of Changes
Other Study ID Numbers: 34
R01HL031989-06A2 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: November 26, 2013
Last Verified: February 2005

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases