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

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ClinicalTrials.gov Identifier: NCT00146107
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : April 23, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Diet Other: Exercise Other: Weight Loss and Exercise Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Weight Loss and Exercise in Frail Obese Elderly Subjects
Study Start Date : January 2005
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: 1
Experimental: 2
Weight loss
Behavioral: Diet
10 percent weight loss through diet and behavioral modification
Experimental: 3
Other: Exercise
Multicomponent (resistance, aerobic, balance) exercise three times a week
Experimental: 4
Weight loss and exercise
Other: Weight Loss and Exercise
10% weight loss through diet and exercise plus multicomponent exercise training three times a week

Outcome Measures

Primary Outcome Measures :
  1. physical function [ Time Frame: one year ]

Secondary Outcome Measures :
  1. body composition [ Time Frame: one year ]
  2. muscle protein synthesis [ Time Frame: one year ]
  3. quality of life [ Time Frame: one year ]
  4. cognition and mood [ Time Frame: one year ]
  5. metabolism [ Time Frame: one year ]
  6. bone mineral density [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146107

United States, Missouri
Washington University School of Medicine
St Louis, Missouri, United States, 63131
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Dennis T Villareal, MD Washington University School of Medicine
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dennis T. Villareal, Associate Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00146107     History of Changes
Other Study ID Numbers: R01AG025501-01 ( U.S. NIH Grant/Contract )
R01AG025501 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013

Keywords provided by Dennis T. Villareal, Washington University School of Medicine:
weight loss
physical function
Obesity in the Elderly

Additional relevant MeSH terms:
Weight Loss
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes