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Weight Loss and Exercise in Obese, Physically Limited, Older Women and Men

Primary Purpose

Obesity

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Diet
Exercise
Weight Loss and Exercise
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, aging, exercise, diet, weight loss, physical function, Obesity in the Elderly

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Obese (BMI 30 or greater) Elderly (age 65 years or older) Frailty Exclusion Criteria: 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.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Weight loss

Exercise

Weight loss and exercise

Outcomes

Primary Outcome Measures

physical function

Secondary Outcome Measures

body composition
muscle protein synthesis
quality of life
cognition and mood
metabolism
bone mineral density

Full Information

First Posted
September 1, 2005
Last Updated
April 22, 2013
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00146107
Brief Title
Weight Loss and Exercise in Obese, Physically Limited, Older Women and Men
Official Title
Weight Loss and Exercise in Frail Obese Elderly Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Obesity causes serious medical complications and impairs quality of life. Moreover, in elderly persons, obesity can lead to frailty by exacerbating the decline in strength, endurance, balance and mobility associated with aging and physical inactivity. The primary objectives of the proposed research are to evaluate the independent and combined effects of weight loss and exercise on physical function, body composition, bone and muscle metabolism, and quality of life in frail, obese elderly men and women. The central hypothesis is that in frail obese elderly subjects, weight loss will improve physical function and quality of life, while the addition of exercise will not only augment improvement in these outcomes, but also attenuate the adverse effects of weight loss on bone and muscle masses. To test this hypothesis, 110 elderly (65-85 years old) obese men and women (body mass index [BMI] > 30 kg/m2) with physical frailty will be randomized to 4 treatment groups: 1) control, 2) 10% weight loss, 3) exercise training, and 4) 10% weight loss plus exercise training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, aging, exercise, diet, weight loss, physical function, Obesity in the Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Title
2
Arm Type
Experimental
Arm Description
Weight loss
Arm Title
3
Arm Type
Experimental
Arm Description
Exercise
Arm Title
4
Arm Type
Experimental
Arm Description
Weight loss and exercise
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Description
10 percent weight loss through diet and behavioral modification
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Multicomponent (resistance, aerobic, balance) exercise three times a week
Intervention Type
Other
Intervention Name(s)
Weight Loss and Exercise
Intervention Description
10% weight loss through diet and exercise plus multicomponent exercise training three times a week
Primary Outcome Measure Information:
Title
physical function
Time Frame
one year
Secondary Outcome Measure Information:
Title
body composition
Time Frame
one year
Title
muscle protein synthesis
Time Frame
one year
Title
quality of life
Time Frame
one year
Title
cognition and mood
Time Frame
one year
Title
metabolism
Time Frame
one year
Title
bone mineral density
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Obese (BMI 30 or greater) Elderly (age 65 years or older) Frailty Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis T Villareal, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15229329
Citation
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.
Results Reference
background
PubMed Identifier
30013511
Citation
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.
Results Reference
derived
PubMed Identifier
28951766
Citation
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.
Results Reference
derived
PubMed Identifier
24787497
Citation
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.
Results Reference
derived
PubMed Identifier
21786319
Citation
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.
Results Reference
derived
PubMed Identifier
21449785
Citation
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.
Results Reference
derived

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Weight Loss and Exercise in Obese, Physically Limited, Older Women and Men

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