Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2010-02-28
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Diet + Resistance Exercise Training
Weekly behavioral/diet-induced weight loss plus supervised resistance exercise training three times a week
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.
Diet + Aerobic Exercise Training
Weekly behavioral/diet-induced weight loss plus supervised aerobic exercise training three times a week
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
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
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
Control Group (No Diet/No Exercise)
No diet No exercise training
No interventions assigned to this group
Interventions
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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.
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
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
Eligibility Criteria
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Inclusion Criteria
* 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 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
65 Years
85 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Baylor College of Medicine
OTHER
Biomedical Research Institute of New Mexico
OTHER
Responsible Party
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Dennis Villareal
Professor of Medicine
Principal Investigators
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Dennis T Villareal, MD FACP FACE
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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New Mexico VA Medical Center and University of New Mexico School of Medicine
Albuquerque, New Mexico, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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Colleluori G, Viola V, Bathina S, Armamento-Villareal R, Qualls C, Giordano A, Villareal DT. Effect of aerobic or resistance exercise, or both on insulin secretion, ciliary neurotrophic factor, and insulin-like growth factor-1 in dieting older adults with obesity. Clin Nutr. 2025 Aug;51:50-62. doi: 10.1016/j.clnu.2025.05.016. Epub 2025 May 28.
Armamento-Villareal R, Aguirre L, Waters DL, Napoli N, Qualls C, Villareal DT. Effect of Aerobic or Resistance Exercise, or Both, on Bone Mineral Density and Bone Metabolism in Obese Older Adults While Dieting: A Randomized Controlled Trial. J Bone Miner Res. 2020 Mar;35(3):430-439. doi: 10.1002/jbmr.3905. Epub 2019 Dec 4.
Colleluori G, Aguirre L, Phadnis U, Fowler K, Armamento-Villareal R, Sun Z, Brunetti L, Hyoung Park J, Kaipparettu BA, Putluri N, Auetumrongsawat V, Yarasheski K, Qualls C, Villareal DT. Aerobic Plus Resistance Exercise in Obese Older Adults Improves Muscle Protein Synthesis and Preserves Myocellular Quality Despite Weight Loss. Cell Metab. 2019 Aug 6;30(2):261-273.e6. doi: 10.1016/j.cmet.2019.06.008. Epub 2019 Jul 3.
Villareal DT, Aguirre L, Gurney AB, Waters DL, Sinacore DR, Colombo E, Armamento-Villareal R, Qualls C. Aerobic or Resistance Exercise, or Both, in Dieting Obese Older Adults. N Engl J Med. 2017 May 18;376(20):1943-1955. doi: 10.1056/NEJMoa1616338.
Other Identifiers
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