Condition(s) treated: Obesity; Obesity in the Elderly

Intervention: diet, exercise (Behavior)

Phase: Phase 3

Enrollment status: Recruiting. Expecting to enroll 100 people.

Sponsor: Washington University School of Medicine

Principal investigator(s) or official(s):
Dennis T Villareal, MD, Principal Investigator, Affiliation: Washington University School of Medicine

Overall contact:
Dennis T Villareal, MD, Phone: 314-286-2715, Email: dvillare@im.wustl.edu

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.

Official title: Weight Loss and Exercise in Frail Obese Elderly Subjects

Study design: Interventional, Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: physical function, body composition, bone mineral density and turnover, muscle protein synthesis, metabolism

Secondary outcome: lipids, glucose tolerance, insulin action, cognition, 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, 100 elderly (65-85 years old) obese men and women (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.

Minimum eligible age: 65 Years. Maximum eligible age: 85 Years. Eligible gender(s): Both.

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, sever orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 yr, current use of bone acting drugs

Dennis T Villareal, MD, Phone: 314-286-2715, Email: dvillare@im.wustl.edu

Washington University School of Medicine, St. Louis, Missouri 63131, United States; Recruiting
Nichole Wright, RD, Phone: 314-747-4113, Email: nwright@im.wustl.edu
Dennis T Villareal, MD, Principal Investigator

click here for more information about the study

Related publications:

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.

Start date: January 2005
End date: December 2009
Last updated: September 2, 2005