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Lifestyle Intervention Trial in Obese Elderly (LITOE)

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ClinicalTrials.gov Identifier: NCT01065636
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : January 22, 2020
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Baylor College of Medicine
Information provided by (Responsible Party):
Dennis Villareal, Baylor College of Medicine

Tracking Information
First Submitted Date  ICMJE February 8, 2010
First Posted Date  ICMJE February 9, 2010
Last Update Posted Date January 22, 2020
Study Start Date  ICMJE February 2010
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2020)
Change in Physical Function [ Time Frame: 6 Months ]
The Physical Performance Test includes seven standardized tasks (walking 15.2 m [50 ft], putting on and removing a coat, picking up a penny, standing up from a chair, lifting a book, climbing one flight of stairs, and performing a progressive Romberg test) plus two additional tasks (going up and down four flights of stairs and making a 360-degree turn). The score for each task ranges from 0 to 4, with higher scores indicating better physical performance; a perfect score would be 36.
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2010)
Physical Function Testing and Body Composition Testing [ Time Frame: 6 Months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2020)
  • Change in lean mass [ Time Frame: 6 months ]
    Assessed using dual energy x-ray absorptiometry (DXA)
  • Change in fat mass [ Time Frame: 6 months ]
    Assessed using DXA
  • Change in muscle strength [ Time Frame: 6 months ]
    Assessed using 1-repetition maximum and dynamometry
  • Change in gait speed [ Time Frame: 6 months ]
    Measured as time to walk a certain distance
  • Change in areal bone mineral density [ Time Frame: 6 months ]
    Assessed by using DXA
  • Change in biochemical marker for bone turnover and bone metabolism [ Time Frame: 6 months ]
    Assessed by using enzyme linked immunoabsorbent assay and radioimmunoassay
  • Change in circulating cytokines [ Time Frame: 6 months ]
    Assessed by using enzyme linked immunoassay
  • Change in adipocytokines [ Time Frame: 6 months ]
    Assessed by using enzyme linked immunoassay
  • Change in aerobic capacity [ Time Frame: 6 months ]
    Assessed by using indirect calorimetry during graded exercise stress test
  • Change in systolic and diastolic blood pressure [ Time Frame: 6 months ]
    Assessed by using sphygmomanometer
  • Change in serum glucose [ Time Frame: 6 months ]
    Assessed by glucose oxidase method
  • Change in serum lipids [ Time Frame: 6 months ]
    Assessed by automated enzymatic/colorimetric assays
  • Change in habitual physical activity assessed by questionnaires [ Time Frame: 6 months ]
    Using the Stanford physical activity questionnaire (score range: 0 to 40 with higher scores indicating higher physical activity levels)
  • Change in habitual physical activity measured objectively [ Time Frame: 6 months ]
    Using accelerometers
  • Change in serum insulin [ Time Frame: 6 months ]
    Assessed by immunoassay
  • Change in serum estradiol [ Time Frame: 6 months ]
    Assessed by immunoassay
  • Change in 25 hydroxyvitamin D [ Time Frame: 6 months ]
    Assessed by immunoassay
  • Change in Impact of Weight on Quality of Life_Lite (IWQOL-lite) score [ Time Frame: 6 months ]
    Assessed by IWQO-liteL questionnaire
  • Change in Medical Outcomes 36-Item short form Health survey (SF-36) [ Time Frame: 6 months ]
    Assessed by Physical component summary and mental component summary score (score range 0 to 100, with higher scores indicating better health status)
  • Change in gene expression of muscle anabolic and catabolic factors [ Time Frame: 6 months ]
    Assessed by reverse transcription polymerase chain reaction and nanostring
  • Change in protein expression of muscle anabolic and catabolic factors [ Time Frame: 6 months ]
    Assessed by western blotting
  • Change in concentration of targeted metabolites [ Time Frame: 6 months ]
    Assessed by liquid chromatography hyphenated with mass spectrometry techniques
  • Change in dynamic balance [ Time Frame: 6 months ]
    Assessed by the obstacle course
  • Change in static balance [ Time Frame: 6 months ]
    Assessed by one leg stance
  • Change in modified mini-mental exam [ Time Frame: 6 months ]
    Assessed by using cognitive instrument testing
  • Change in word fluency [ Time Frame: 6 months ]
    Assessed by using cognitive instrument testing
  • Change in trail a and trail b [ Time Frame: 6 months ]
    Assessed by using cognitive instrument testing
  • Change in Ray Auditory verbal learning test [ Time Frame: 6 months ]
    Assessed by using cognitive instrument testing
  • Change in muscle protein synthesis rate [ Time Frame: 6 months ]
    Assessed by stable isotope methodology
  • Change in thigh muscle and fat mass [ Time Frame: 6 months ]
    Assessed by magnetic resonance imaging (MRI)
  • Change in visceral fat mass [ Time Frame: 6 months ]
    Assessed by MRI
  • Change in mood [ Time Frame: 6 months ]
    Assessed by geriatric depression scale (score range: 0 to 30, where lower scores indicating better mood)
  • Change in waist circumference [ Time Frame: 6 months ]
    Using a tape measure
  • Change in serum testosterone [ Time Frame: 6 months ]
    Assessed by immunoassay
  • Change in subjective ability to function [ Time Frame: 6 months ]
    Assessed by Functional Status Questionnaire (score range: 0 to 36 with higher scores indicating better function)
  • Change is serum sclerostin [ Time Frame: 6 months ]
    Assessed by immunoassay
  • Change in parathyroid hormone [ Time Frame: 6 months ]
    Assessed by immunoassay
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2010)
Cognition, mood, quality of life [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle Intervention Trial in Obese Elderly
Official Title  ICMJE Exercise Interventions During Voluntary Weight Loss in Obese Older Adults
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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.
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Diet + Resistance Exercise Training
    Weekly behavioral/diet-induced weight loss plus supervised resistance exercise training three times a week
    Intervention: Behavioral: Diet + Resistance Training
  • Experimental: Diet + Aerobic Exercise Training
    Weekly behavioral/diet-induced weight loss plus supervised aerobic exercise training three times a week
    Intervention: Behavioral: Diet + Aerobic Training
  • Experimental: Diet + Combined Aerobic/Resistance Exercise
    Weekly behavioral/diet-induced weight loss plus combined supervised resistance exercise training and aerobic exercise training three times a week
    Intervention: Behavioral: Diet + Resistance/Aerobic Exercise
  • No Intervention: Control Group (No Diet/No Exercise)
    No diet No exercise training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2010)
160
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01065636
Other Study ID Numbers  ICMJE R01AG031176( U.S. NIH Grant/Contract )
R01AG031176 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dennis Villareal, Baylor College of Medicine
Study Sponsor  ICMJE Biomedical Research Institute of New Mexico
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • Baylor College of Medicine
Investigators  ICMJE
Principal Investigator: Dennis T Villareal, MD FACP FACE Baylor College of Medicine
PRS Account Biomedical Research Institute of New Mexico
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP