NCT00146107

Brief Summary

The purpose of this study is to determine the effect of weight loss and exercise on physical function, body fat and muscle mass, bone strength, and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P25-P50 for phase_3 obesity

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_3 obesity

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

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

5.9 years

First QC Date

September 1, 2005

Last Update Submit

April 22, 2013

Conditions

Obesity

Keywords

obesityagingexercisedietweight lossphysical functionObesity in the Elderly

Outcome Measures

Primary Outcomes (1)

  • physical function

    one year

Secondary Outcomes (6)

  • body composition

    one year

  • muscle protein synthesis

    one year

  • quality of life

    one year

  • cognition and mood

    one year

  • metabolism

    one year

  • +1 more secondary outcomes

Study Arms (4)

1

NO INTERVENTION

2

EXPERIMENTAL

Weight loss

Behavioral: Diet

3

EXPERIMENTAL

Exercise

Other: Exercise

4

EXPERIMENTAL

Weight loss and exercise

Other: Weight Loss and Exercise

Interventions

DietBEHAVIORAL

10 percent weight loss through diet and behavioral modification

2
ExerciseOTHER

Multicomponent (resistance, aerobic, balance) exercise three times a week

3
Weight Loss and ExerciseOTHER

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

4

Eligibility Criteria

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

You may qualify if:

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

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, or current use of bone acting drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63131, United States

Location

Related Publications (6)

  • 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

  • Colleluori G, Chen R, Napoli N, Aguirre LE, Qualls C, Villareal DT, Armamento-Villareal R. Fat Mass Follows a U-Shaped Distribution Based on Estradiol Levels in Postmenopausal Women. Front Endocrinol (Lausanne). 2018 Jul 2;9:315. doi: 10.3389/fendo.2018.00315. eCollection 2018.

    PMID: 30013511DERIVED

  • Colleluori G, Napoli N, Phadnis U, Armamento-Villareal R, Villareal DT. Effect of Weight Loss, Exercise, or Both on Undercarboxylated Osteocalcin and Insulin Secretion in Frail, Obese Older Adults. Oxid Med Cell Longev. 2017;2017:4807046. doi: 10.1155/2017/4807046. Epub 2017 Aug 23.

    PMID: 28951766DERIVED

  • Napoli N, Shah K, Waters DL, Sinacore DR, Qualls C, Villareal DT. Effect of weight loss, exercise, or both on cognition and quality of life in obese older adults. Am J Clin Nutr. 2014 Jul;100(1):189-98. doi: 10.3945/ajcn.113.082883. Epub 2014 Apr 30.

    PMID: 24787497DERIVED

  • Shah K, Armamento-Villareal R, Parimi N, Chode S, Sinacore DR, Hilton TN, Napoli N, Qualls C, Villareal DT. Exercise training in obese older adults prevents increase in bone turnover and attenuates decrease in hip bone mineral density induced by weight loss despite decline in bone-active hormones. J Bone Miner Res. 2011 Dec;26(12):2851-9. doi: 10.1002/jbmr.475.

    PMID: 21786319DERIVED

  • Villareal DT, Chode S, Parimi N, Sinacore DR, Hilton T, Armamento-Villareal R, Napoli N, Qualls C, Shah K. Weight loss, exercise, or both and physical function in obese older adults. N Engl J Med. 2011 Mar 31;364(13):1218-29. doi: 10.1056/NEJMoa1008234.

    PMID: 21449785DERIVED

MeSH Terms

Conditions

ObesityMotor ActivityWeight Loss

Interventions

DietExercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor 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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

January 1, 2005

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations

US(1)