NCT00779207

Brief Summary

The purpose of this study is to determine the effect of weight loss and exercise on liver and muscle fat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3 obesity

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
Last Updated

October 24, 2008

Status Verified

October 1, 2008

Enrollment Period

1.8 years

First QC Date

October 22, 2008

Last Update Submit

October 23, 2008

Conditions

Obesity

Keywords

obesityagingexercisedietweight lossphysical functionObesity in the Elderly

Outcome Measures

Primary Outcomes (1)

  • Intrahepatic fat Intramyocellular fat

    6-month

Secondary Outcomes (1)

  • Insulin sensitivity Physical Function

    6-month

Study Arms (2)

1

EXPERIMENTAL

weight loss

Behavioral: weight loss

2

EXPERIMENTAL

Weight loss and exercise

Behavioral: weight loss and exercise

Interventions

weight loss and exerciseBEHAVIORAL

10% weight loss through diet and exercise plus multicomponent exercise training three times a week

Also known as: lifestyle modification
2
weight lossBEHAVIORAL

10 percent weight loss through diet and behavioral modification

Also known as: lifestyle change
1

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Obese (BMI 30 or greater)
  • Elderly (age 65 years or older)

You may not qualify if:

  • Major chronic disease or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results. Examples include cardiopulmonary disease, unstable disease, severe orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Related Publications (1)

  • Villareal DT, Banks M, Siener C, Sinacore DR, Klein S. Physical frailty and body composition in obese elderly men and women. Obes Res. 2004 Jun;12(6):913-20. doi: 10.1038/oby.2004.111.

    PMID: 15229329BACKGROUND

MeSH Terms

Conditions

ObesityMotor ActivityWeight Loss

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBody Weight Changes

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dennis T Villareal, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 24, 2008

Study Start

November 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

October 24, 2008

Record last verified: 2008-10

Locations

US(1)