CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 120 enrolled
Drug / intervention
Medium-intensity Minimally-directive Counselingbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00324545
NCT00324545Phase 3Completed
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Long-term Adherence and Cardiovascular Outcomes of a Randomized Controlled Trial of Medium-intensity Minimally-directive Counseling for Different Diets

The Camelot Foundation·interventional·Posted May 11, 2006·Updated Jul 21, 2020

In Brief

A Phase 3 clinical trial evaluating Medium-intensity Minimally-directive Counseling for Coronary Artery Disease and Obesity. Completed, enrolled 120 participants across 2 sites.

Detailed Summary

(1) What effect does behavioral counseling for vegan, for low to moderate fat, and for lowered carbohydrate diets have on coronary blood flow? (2) What are the effects of different diet protocols when caloric intake and exercise are equalized? (3) Do people, so counseled, maintain their modified behaviors after they have completed their diet program? (4) How does targeting different diets affect secondary indices associated with heart disease such as weight, lipid, inflammatory, and thrombotic factors?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Obesity
CountriesUnited States
CollaboratorsGM Harrington, PhD

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 11, 2006
Enrollment StartJan 1, 2000
Primary CompletionDec 31, 2002
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.1 years ago

Interventions

Medium-intensity Minimally-directive Counselingbehavioral