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Lifestyle Intervention Trial in Obese Elderly (LITOE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Baylor College of Medicine
Information provided by (Responsible Party):
Dennis Villareal, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01065636
First received: February 8, 2010
Last updated: January 25, 2017
Last verified: January 2017
  Purpose
Obesity causes frailty in obese older adults by exacerbating the age-related decline in physical function. However, appropriate management of obesity in older adults is controversial. Weight loss without exercise could worsen frailty by accelerating the usual age-related decline in muscle and bone mass that leads to sarcopenia and osteopenia, respectively. Because of the important problem of frailty in obese older adults, it is important to determine the most efficacious approach in reducing, or even reversing frailty in this population. The primary objective of this proposal is to evaluate which distinct type of physical exercise (resistance, aerobic, or combined resistance + aerobic) is most efficacious in preventing the weight-loss-induced reduction in muscle and bone mass and reversing frailty in obese older adults.

Condition Intervention
Obesity Behavioral: Diet + Resistance Training Behavioral: Diet + Aerobic Training Behavioral: Diet + Resistance/Aerobic Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise Interventions During Voluntary Weight Loss in Obese Older Adults

Resource links provided by NLM:


Further study details as provided by Dennis Villareal, Baylor College of Medicine:

Primary Outcome Measures:
  • Physical Function and Body Composition [ Time Frame: 6 Months ]

Secondary Outcome Measures:
  • Bone markers, hormones, muscle cytokines, muscle protein synthesis, cardiometabolic risk factors, cognition, mood, quality of life [ Time Frame: 6 months ]

Estimated Enrollment: 160
Study Start Date: February 2010
Estimated Study Completion Date: April 2017
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet + Resistance Exercise Training Behavioral: Diet + Resistance Training
Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and resistance exercise training 3-days/week for 24 weeks.
Experimental: Diet + Aerobic Exercise Training Behavioral: Diet + Aerobic Training
Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and aerobic exercise training 3-days/week for 24 weeks
Experimental: Diet + Combined Aerobic/Resistance Exercise Behavioral: Diet + Resistance/Aerobic Exercise
Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and combined resistance/aerobic exercise training 3-days/week for 24 weeks
No Intervention: Control Group (No Diet/No Exercise)

  Eligibility

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

Inclusion Criteria:

  • 65-85 years old
  • Obese men and women (BMI > or equal to 30 kg/m2)
  • Stable weight (±2 kg) during the last 6 mos.
  • Must be sedentary (regular exercise <1 h/wk or <2 x/wk for the last 6 mos.)
  • Be judged, during the initial screening, to be well motivated and reliable

Exclusion Criteria:

  • Any major chronic diseases
  • Any condition or unstable diseases that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results that include but are not limited to:
  • Cardiopulmonary disease (e.g., recent MI, unstable angina, stroke etc.)
  • Severe orthopedic/musculoskeletal or neuromuscular impairments that would contraindicate participation in exercise
  • Visual or hearing impairments that interfere with following directions
  • Diagnosis of dementia
  • History of malignancy during the past 5 yr
  • Recent use of bone acting drugs (e.g. use of estrogen, or androgen containing compound, raloxifene, calcitonin, parathyroid hormone during the past year or biphosphonates during the last two years)
  • Individuals on insulin or with a fasting blood glucose of > 140mg/dl, and/or a 2 hour post-glucose of >250 mg/dl
  • BMD t-scores of <-2.3 of the lumbar spine and proximal femur
  • serum creatinine >2.0 mg/dl
  • No commitments, life situations or conditions that would interfere with their participation in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065636

Locations
United States, New Mexico
New Mexico VA Medical Center and University of New Mexico School of Medicine
Albuquerque, New Mexico, United States, 87108
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Biomedical Research Institute of New Mexico
National Institute on Aging (NIA)
Baylor College of Medicine
Investigators
Principal Investigator: Dennis T Villareal, MD FACP FACE Baylor College of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dennis Villareal, Professor of Medicine, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01065636     History of Changes
Other Study ID Numbers: R01AG031176 ( U.S. NIH Grant/Contract )
Study First Received: February 8, 2010
Last Updated: January 25, 2017

ClinicalTrials.gov processed this record on August 18, 2017