Lifestyle Intervention Trial in Obese Elderly (LITOE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Biomedical Research Institute of New Mexico
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dennis Villareal, Biomedical Research Institute of New Mexico
ClinicalTrials.gov Identifier:
NCT01065636
First received: February 8, 2010
Last updated: January 9, 2014
Last verified: January 2014
  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 Blind (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 Biomedical Research Institute of New Mexico:

Primary Outcome Measures:
  • Physical Function and Body Composition [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Bone markers, hormones, muscle cytokines, muscle protein synthesis, cardiometabolic risk factors, cognition, mood, quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: February 2010
Estimated Primary Completion Date: January 2015 (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 24 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 24 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 24 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
Genders Eligible for Study:   Both
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 >1.5mg/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

Contacts
Contact: Kenneth Fowler, BS 505-222-3616 Kenneth.Fowler2@va.gov

Locations
United States, New Mexico
New Mexico VA Medical Center and University of New Mexico School of Medicine Recruiting
Albuquerque, New Mexico, United States, 87108
Contact: Sheryl Pascual    505-265-1711 ext 3616    sheryl.pascual@va.gov   
Sponsors and Collaborators
Biomedical Research Institute of New Mexico
Investigators
Principal Investigator: Dennis T Villareal, MD FACP FACE New Mexico VA Health Care System/University of New Mexico School of Medicine
  More Information

No publications provided

Responsible Party: Dennis Villareal, Professor and Chief, Geriatrics - New Mexico VA Health Care System and the University of New Mexico School of Medicine, Biomedical Research Institute of New Mexico
ClinicalTrials.gov Identifier: NCT01065636     History of Changes
Other Study ID Numbers: R01-AG031176, R01AG031176
Study First Received: February 8, 2010
Last Updated: January 9, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014