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CompletedNCT01065636LITOEUpdated Jan 22, 2020

Lifestyle Intervention Trial in Obese Elderly

An interventional study of Diet + Resistance Training and Diet + Aerobic Training in Obesity, sponsored by Biomedical Research Institute of New Mexico. Completed at 2 sites in United States. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-01-22.

Sponsored by Biomedical Research Institute of New Mexico · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
65 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
03

In context

Lead sponsor

Biomedical Research Institute of New Mexico is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    Diet + Resistance Exercise Training

    Weekly behavioral/diet-induced weight loss plus supervised resistance exercise training three times a week

    Behavioral: Diet + Resistance Training

  • Experimental
    Diet + Aerobic Exercise Training

    Weekly behavioral/diet-induced weight loss plus supervised aerobic exercise training three times a week

    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

    Behavioral: Diet + Resistance/Aerobic Exercise

  • No intervention
    Control Group (No Diet/No Exercise)

    No diet No exercise training

Interventions

  • BehavioralDiet + 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.

  • BehavioralDiet + 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

  • BehavioralDiet + 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

06

What researchers measure

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.

    Time frame: 6 Months

Secondary outcomes

  1. Change in lean mass

    Assessed using dual energy x-ray absorptiometry (DXA)

    Time frame: 6 months

  2. Change in fat mass

    Assessed using DXA

    Time frame: 6 months

  3. Change in muscle strength

    Assessed using 1-repetition maximum and dynamometry

    Time frame: 6 months

  4. Change in gait speed

    Measured as time to walk a certain distance

    Time frame: 6 months

  5. Change in areal bone mineral density

    Assessed by using DXA

    Time frame: 6 months

  6. Change in biochemical marker for bone turnover and bone metabolism

    Assessed by using enzyme linked immunoabsorbent assay and radioimmunoassay

    Time frame: 6 months

  7. Change in circulating cytokines

    Assessed by using enzyme linked immunoassay

    Time frame: 6 months

  8. Change in adipocytokines

    Assessed by using enzyme linked immunoassay

    Time frame: 6 months

  9. Change in aerobic capacity

    Assessed by using indirect calorimetry during graded exercise stress test

    Time frame: 6 months

  10. Change in systolic and diastolic blood pressure

    Assessed by using sphygmomanometer

    Time frame: 6 months

  11. Change in serum glucose

    Assessed by glucose oxidase method

    Time frame: 6 months

  12. Change in serum lipids

    Assessed by automated enzymatic/colorimetric assays

    Time frame: 6 months

  13. Change in habitual physical activity assessed by questionnaires

    Using the Stanford physical activity questionnaire (score range: 0 to 40 with higher scores indicating higher physical activity levels)

    Time frame: 6 months

  14. Change in habitual physical activity measured objectively

    Using accelerometers

    Time frame: 6 months

  15. Change in serum insulin

    Assessed by immunoassay

    Time frame: 6 months

  16. Change in serum estradiol

    Assessed by immunoassay

    Time frame: 6 months

  17. Change in 25 hydroxyvitamin D

    Assessed by immunoassay

    Time frame: 6 months

  18. Change in Impact of Weight on Quality of Life_Lite (IWQOL-lite) score

    Assessed by IWQO-liteL questionnaire

    Time frame: 6 months

  19. Change in Medical Outcomes 36-Item short form Health survey (SF-36)

    Assessed by Physical component summary and mental component summary score (score range 0 to 100, with higher scores indicating better health status)

    Time frame: 6 months

  20. Change in gene expression of muscle anabolic and catabolic factors

    Assessed by reverse transcription polymerase chain reaction and nanostring

    Time frame: 6 months

  21. Change in protein expression of muscle anabolic and catabolic factors

    Assessed by western blotting

    Time frame: 6 months

  22. Change in concentration of targeted metabolites

    Assessed by liquid chromatography hyphenated with mass spectrometry techniques

    Time frame: 6 months

  23. Change in dynamic balance

    Assessed by the obstacle course

    Time frame: 6 months

  24. Change in static balance

    Assessed by one leg stance

    Time frame: 6 months

  25. Change in modified mini-mental exam

    Assessed by using cognitive instrument testing

    Time frame: 6 months

  26. Change in word fluency

    Assessed by using cognitive instrument testing

    Time frame: 6 months

  27. Change in trail a and trail b

    Assessed by using cognitive instrument testing

    Time frame: 6 months

  28. Change in Ray Auditory verbal learning test

    Assessed by using cognitive instrument testing

    Time frame: 6 months

  29. Change in muscle protein synthesis rate

    Assessed by stable isotope methodology

    Time frame: 6 months

  30. Change in thigh muscle and fat mass

    Assessed by magnetic resonance imaging (MRI)

    Time frame: 6 months

  31. Change in visceral fat mass

    Assessed by MRI

    Time frame: 6 months

  32. Change in mood

    Assessed by geriatric depression scale (score range: 0 to 30, where lower scores indicating better mood)

    Time frame: 6 months

  33. Change in waist circumference

    Using a tape measure

    Time frame: 6 months

  34. Change in serum testosterone

    Assessed by immunoassay

    Time frame: 6 months

  35. Change in subjective ability to function

    Assessed by Functional Status Questionnaire (score range: 0 to 36 with higher scores indicating better function)

    Time frame: 6 months

  36. Change is serum sclerostin

    Assessed by immunoassay

    Time frame: 6 months

  37. Change in parathyroid hormone

    Assessed by immunoassay

    Time frame: 6 months

07

Study locations

2 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 31797417 ↗
  • 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. PubMed 31279675 ↗
  • 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. PubMed 28514618 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01065636
Lead sponsor
Biomedical Research Institute of New Mexico
Collaborators
National Institute on Aging (NIA), Baylor College of Medicine
Responsible party
Dennis Villareal (Professor of Medicine, Baylor College of Medicine) — Principal investigator
First posted
Feb 9, 2010
Start date
Feb 2010
Primary completion
Jan 2016
Completion
Dec 31, 2018
Last update
Jan 22, 2020

Study contacts

Dennis T Villareal, MD FACP FACE
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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