NCT00000515

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 1984

Longer than P75 for phase_3 cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1984

Completed
8.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1992

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

November 26, 2013

Status Verified

February 1, 2005

First QC Date

October 27, 1999

Last Update Submit

November 25, 2013

Conditions

Cardiovascular DiseasesHeart DiseasesHypertensionObesity

Interventions

diet, reducingBEHAVIORAL

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
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.

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Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHypertensionObesity

Interventions

Diet, Reducing

Condition Hierarchy (Ancestors)

Vascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • George Blackburn

    Beth Israel Deaconess Medical Center

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

July 1, 1984

Study Completion

September 1, 1992

Last Updated

November 26, 2013

Record last verified: 2005-02