Lifestyle Intervention Trial in Obese Elderly
LITOE
Exercise Interventions During Voluntary Weight Loss in Obese Older Adults
1 other identifier
interventional
160
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Feb 2010
Longer than P75 for not_applicable obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 8, 2010
CompletedFirst Posted
Study publicly available on registry
February 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJanuary 22, 2020
January 1, 2020
5.9 years
February 8, 2010
January 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Physical Function
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.
6 Months
Secondary Outcomes (37)
Change in lean mass
6 months
Change in fat mass
6 months
Change in muscle strength
6 months
Change in gait speed
6 months
Change in areal bone mineral density
6 months
- +32 more secondary outcomes
Study Arms (4)
Diet + Resistance Exercise Training
EXPERIMENTALWeekly behavioral/diet-induced weight loss plus supervised resistance exercise training three times a week
Diet + Aerobic Exercise Training
EXPERIMENTALWeekly behavioral/diet-induced weight loss plus supervised aerobic exercise training three times a week
Diet + Combined Aerobic/Resistance Exercise
EXPERIMENTALWeekly behavioral/diet-induced weight loss plus combined supervised resistance exercise training and aerobic exercise training three times a week
Control Group (No Diet/No Exercise)
NO INTERVENTIONNo diet No exercise training
Interventions
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 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 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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biomedical Research Institute of New Mexicolead
- National Institute on Aging (NIA)collaborator
- Baylor College of Medicinecollaborator
Study Sites (2)
New Mexico VA Medical Center and University of New Mexico School of Medicine
Albuquerque, New Mexico, 87108, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (4)
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.
PMID: 40527119DERIVEDArmamento-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.
PMID: 31797417DERIVEDColleluori 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.
PMID: 31279675DERIVEDVillareal 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.
PMID: 28514618DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis T Villareal, MD FACP FACE
Baylor College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
February 8, 2010
First Posted
February 9, 2010
Study Start
February 1, 2010
Primary Completion
January 1, 2016
Study Completion
December 31, 2018
Last Updated
January 22, 2020
Record last verified: 2020-01