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ObesityLITOENCT01065636

Lifestyle Intervention Trial in Obese Elderly

A study testing Diet + Resistance Training, Diet + Aerobic Training and Diet + Resistance/Aerobic Exercise in people with Obesity, run by Biomedical Research Institute of New Mexico at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Obesity
What is being tested?
Diet + Resistance Training, Diet + Aerobic Training and Diet + Resistance/Aerobic Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
2 sitesUnited States
Study dates
Feb 2010to 31 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • New Mexico VA Medical Center and University of New Mexico School of Medicine

    Albuquerque, New Mexico, 87108

  • Baylor College of Medicine

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Exercise Interventions During Voluntary Weight Loss in Obese Older Adults

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.

Conditions
Obesity
Being tested
Diet + Resistance Training, Diet + Aerobic Training, Diet + Resistance/Aerobic Exercise
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diet + Resistance TrainingBehavioural

    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 TrainingBehavioural

    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 ExerciseBehavioural

    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 groups in NCT01065636
Study groupRoleWhat they receive
Diet + Resistance Exercise TrainingExperimentalWeekly behavioral/diet-induced weight loss plus supervised resistance exercise training three times a week
Receives: Behavioral: Diet + Resistance Training
Diet + Aerobic Exercise TrainingExperimentalWeekly behavioral/diet-induced weight loss plus supervised aerobic exercise training three times a week
Receives: Behavioral: Diet + Aerobic Training
Diet + Combined Aerobic/Resistance ExerciseExperimentalWeekly behavioral/diet-induced weight loss plus combined supervised resistance exercise training and aerobic exercise training three times a week
Receives: Behavioral: Diet + Resistance/Aerobic Exercise
Control Group (No Diet/No Exercise)No interventionNo diet No exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 Months

Secondary outcomes (37)

  1. Change in lean mass

    Assessed using dual energy x-ray absorptiometry (DXA)

    Measured: 6 months

  2. Change in fat mass

    Assessed using DXA

    Measured: 6 months

  3. Change in muscle strength

    Assessed using 1-repetition maximum and dynamometry

    Measured: 6 months

  4. Change in gait speed

    Measured as time to walk a certain distance

    Measured: 6 months

  5. Change in areal bone mineral density

    Assessed by using DXA

    Measured: 6 months

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

    Assessed by using enzyme linked immunoabsorbent assay and radioimmunoassay

    Measured: 6 months

  7. Change in circulating cytokines

    Assessed by using enzyme linked immunoassay

    Measured: 6 months

  8. Change in adipocytokines

    Assessed by using enzyme linked immunoassay

    Measured: 6 months

  9. Change in aerobic capacity

    Assessed by using indirect calorimetry during graded exercise stress test

    Measured: 6 months

  10. Change in systolic and diastolic blood pressure

    Assessed by using sphygmomanometer

    Measured: 6 months

  11. Change in serum glucose

    Assessed by glucose oxidase method

    Measured: 6 months

  12. Change in serum lipids

    Assessed by automated enzymatic/colorimetric assays

    Measured: 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)

    Measured: 6 months

  14. Change in habitual physical activity measured objectively

    Using accelerometers

    Measured: 6 months

  15. Change in serum insulin

    Assessed by immunoassay

    Measured: 6 months

  16. Change in serum estradiol

    Assessed by immunoassay

    Measured: 6 months

  17. Change in 25 hydroxyvitamin D

    Assessed by immunoassay

    Measured: 6 months

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

    Assessed by IWQO-liteL questionnaire

    Measured: 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)

    Measured: 6 months

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

    Assessed by reverse transcription polymerase chain reaction and nanostring

    Measured: 6 months

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

    Assessed by western blotting

    Measured: 6 months

  22. Change in concentration of targeted metabolites

    Assessed by liquid chromatography hyphenated with mass spectrometry techniques

    Measured: 6 months

  23. Change in dynamic balance

    Assessed by the obstacle course

    Measured: 6 months

  24. Change in static balance

    Assessed by one leg stance

    Measured: 6 months

  25. Change in modified mini-mental exam

    Assessed by using cognitive instrument testing

    Measured: 6 months

  26. Change in word fluency

    Assessed by using cognitive instrument testing

    Measured: 6 months

  27. Change in trail a and trail b

    Assessed by using cognitive instrument testing

    Measured: 6 months

  28. Change in Ray Auditory verbal learning test

    Assessed by using cognitive instrument testing

    Measured: 6 months

  29. Change in muscle protein synthesis rate

    Assessed by stable isotope methodology

    Measured: 6 months

  30. Change in thigh muscle and fat mass

    Assessed by magnetic resonance imaging (MRI)

    Measured: 6 months

  31. Change in visceral fat mass

    Assessed by MRI

    Measured: 6 months

  32. Change in mood

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

    Measured: 6 months

  33. Change in waist circumference

    Using a tape measure

    Measured: 6 months

  34. Change in serum testosterone

    Assessed by immunoassay

    Measured: 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)

    Measured: 6 months

  36. Change is serum sclerostin

    Assessed by immunoassay

    Measured: 6 months

  37. Change in parathyroid hormone

    Assessed by immunoassay

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionJan 2016
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01065636
Sponsor's protocol ID
R01AG031176
Other IDs
R01AG031176
Acronym
LITOE
Status last verified
Jan 2020
First submitted
8 Feb 2010
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 40527119

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Diet + Resistance Training, Diet + Aerobic Training and Diet + Resistance/Aerobic Exercise in people with Obesity, run by Biomedical Research Institute of New Mexico at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Physical Function (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01065636, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.

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