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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dennis T. Villareal, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00146107
First received: September 1, 2005
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Obesity
 Behavioral: Diet
Other: Exercise
Other: Weight Loss and Exercise
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Weight Loss and Exercise in Frail Obese Elderly Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • physical function [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body composition [ Time Frame: one year ] [ Designated as safety issue: No ]
  • muscle protein synthesis [ Time Frame: one year ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
  • cognition and mood [ Time Frame: one year ] [ Designated as safety issue: No ]
  • metabolism [ Time Frame: one year ] [ Designated as safety issue: No ]
  • bone mineral density [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 107
Study Start Date: January 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Experimental: 2
Weight loss
 Behavioral: Diet
10 percent weight loss through diet and behavioral modification
Experimental: 3
Exercise
 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

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.

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146107

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

Publications:

Additional 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, R01AG025501
Study First Received: September 1, 2005
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
obesity
aging
exercise
diet
 weight loss
physical function
Obesity in the Elderly

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

ClinicalTrials.gov processed this record on May 23, 2013