CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 167 enrolled
Drug / intervention
Exercise +2 morebehavioral
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/NCT00955903
NCT00955903Phase 3Completed
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Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults

University of Alabama at Birmingham·interventional·Posted Aug 10, 2009·Updated Sep 5, 2017

In Brief

A Phase 3 clinical trial evaluating Exercise, Reduced Calorie Diet, and 1 other intervention for Obesity and 3 related conditions. Completed, enrolled 167 participants across 1 site.

Detailed Summary

The investigators want to determine if the benefits of weight loss outweigh the potential risk in a group of older adults. The investigators will test the hypothesis that changes in diet composition alone or in conjunction with weight loss will have a significant effect on fat stores, and as a result, improve cardiometabolic risk factors and functional status in adults 65 and older.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Diabetes, Hypertension, Hyperlipidemia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2009
Enrollment StartJun 1, 2010
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 16.9 years ago

Interventions

Exercisebehavioral

Participants will participate in supervised exercise sessions

Reduced Calorie Dietbehavioral

Participants will follow a reduced calorie diet

Weight Maintenance Dietbehavioral

Participants will follow a weight maintenance diet