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Lifestyle Intervention to Improve Bone Quality (LIMB-Q)

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ClinicalTrials.gov Identifier: NCT03329963
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : April 19, 2018
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Michael Debakey Veterans Affairs Medical Center
Biomedical Research Institute of New Mexico
Information provided by (Responsible Party):
Dennis T. Villareal, Baylor College of Medicine

Brief Summary:
Obese older adults will be randomized to participate in either healthy lifestyle intervention or behavioral diet and exercise intervention for one year. This study aims to determine the effects of Lifestyle intervention on bone microarchitecture, bone strength, bone material properties, and the mechanism behind it.

Condition or disease Intervention/treatment Phase
Aging Obesity Behavioral: Healthy Lifestyle Intervention Behavioral: Lifestyle Intervention Not Applicable

Detailed Description:
Previous studies had suggested that lifestyle therapy (diet plus exercise) resulting in weight loss in elderly population improves physical function, cardio metabolic risk factors, and cognition/quality of life, but a major complication is loss of BMD. The addition of exercise to diet-induced weight loss attenuated but did not eliminate weight-loss-induced reduction of BMD. Moreover, while long-term maintenance of weight loss and physical function was feasible, sustained lifestyle change led to continued loss of hip BMD, which might predict hip fractures. Although similar BMD loss with weight loss has been observed in younger populations, BMD loss in older adults might be of particular concern because of aggravation of age-related bone loss. Moreover, the belief that obesity protects against fractures has now been challenged by studies demonstrating that obesity is associated with poor bone quality and ankle and leg fractures.Because of previous lack of options to assess bone quality in vivo, there has been little or no scientific study of the possibility that lifestyle therapy in obese older adults improves bone quality. This study represents an unprecedented opportunity to prove the hypothesis that lifestyle therapy intervention improves bone quality and thus, may confer a protective rather than adverse effect on bone health. This will be the first randomized controlled trial (RCT) to comprehensively assess bone quality using novel techniques in response to lifestyle therapy in obese older adults, with major ramifications with regards to defining optimal treatment strategies for this increasingly high-risk older population.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Lifestyle Intervention Improve Bone Quality in Obese Older Adults?
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

Arm Intervention/treatment
Experimental: Lifestyle intervention Group
Behavioral therapy for weight loss and Exercise Training
Behavioral: Lifestyle Intervention

The lifestyle modification will be achieved by group behavior therapy sessions designed to have older adults acquire positive weight-control skills/attitudes, and practice weight-maintenance skills.Participants will attend weekly group sessions (10-15 persons), which will last ~75-90 minutes. Visit frequency will be decreased to every 2 wks. from 6 to 12 mos. to prevent "treatment fatigue". A balanced diet will be prescribed to provide a deficit of 500-750 kcal/day from daily energy requirement.

The exercise sessions are of ~90 min duration (~15 min warm-up of flexibility exercise, followed by ~30 min of aerobic exercise, and after a brief rest period, ~30 min of resistance training, and finally ~15 min balance exercise) conducted three times weekly supervised at our exercise facility for one year. Aerobic exercises consist of treadmill, stationary cycling, and stair climbing.


Active Comparator: Healthy lifestyle intervention Group
Group education sessions that focus on diet exercise and social support.
Behavioral: Healthy Lifestyle Intervention
Participants in the this group will receive group educational sessions that focus on diet, exercise, and social support once a month throughout the study. The sessions will provide an opportunity for participants to discuss issues related to living with obesity and aging.Participants will also attend regular scheduled clinic visits for assessment of outcomes.




Primary Outcome Measures :
  1. Change in cortical thickness [ Time Frame: Change from baseline at 12 months ]
    Assessed by using high-resolution peripheral computed tomography (HR-pQCT)

  2. Change in femoral bone strength [ Time Frame: Change from baseline at 12 months ]
    Assessed by using finite element analyses (FEA) of quantitative computed tomography (QCT)

  3. Change in bone material strength [ Time Frame: Change from baseline at 12 months ]
    Assessed by using microindentation testing.


Secondary Outcome Measures :
  1. Change in lower extremity strength [ Time Frame: Change from baseline at 12 months ]
    Assessed by using a Biodex dynamometer

  2. Change in physical performance test [ Time Frame: Change from baseline at 12 months ]
    assessed by using the objective physical performance test

  3. Change in gait speed [ Time Frame: Change from baseline at 12 months ]
    as measured by completing the time to walk a certain distance

  4. Change in handgrip strength [ Time Frame: Change from baseline at 12 months ]
    Measured by hydraulic hand dynamometer

  5. Change in trabecular thickness [ Time Frame: Change from baseline at 12 months ]
    Assessed by using HR-pQCT

  6. Change in areal bone mineral density (BMD) [ Time Frame: Change from baseline at 12 months ]
    Assessed by using dual-energy x-ray absorptiometry

  7. Change in trabecular number [ Time Frame: Change from baseline at 12 month ]
    Assessed by using HR-pQCT

  8. Change in total volumetric BMD [ Time Frame: Change from baseline at 12 months ]
    Assessed by using HR-pQCT

  9. Change in cortical volumetric BMD [ Time Frame: Change from baseline at 12 months ]
    Assessed by using HR-pQCT

  10. Change in trabecular volumetric BMD [ Time Frame: Change from baseline at 12 months ]
    Assessed by using HR-pQCT

  11. Change in stiffness [ Time Frame: Change from baseline at 12 months ]
    Assessed by using HR-pQCT

  12. Change in trabecular separation [ Time Frame: Change from baseline at 12 months ]
    Assessed by using HR-pQCT

  13. Change in cortical porosity [ Time Frame: Change from baseline at 12 months ]
    Assessed by using HR-pQCT

  14. Change in micro-finite element analyses strength [ Time Frame: Change from baseline at 12 months ]
    Assessed by using HR-pQCT

  15. Change in general quality of life [ Time Frame: Change from baseline at 12 months ]
    Assessed by using the Short Form-36 questionnaire

  16. Change in obesity specific quality of life [ Time Frame: Change from baseline at 12 months ]
    Assessed by using the Impact of weight on quality of life short form (IWQOL-Lite) questionnaire

  17. Change in mood [ Time Frame: Change from baseline at 12 months ]
    Assessed by using a mood scale questionnaire

  18. Change in composite cognitive z-score [ Time Frame: Change from baseline at 12 months ]
    Using cognitive instrument testing

  19. Change in modified mini-mental exam [ Time Frame: Change from baseline at 12 months ]
    Assessed by using cognitive instrument testing

  20. Change in word list fluency [ Time Frame: Change from baseline at 12 months ]
    Assessed by using cognitive instrument testing

  21. Change in Ray Auditory verbal learning test [ Time Frame: Change from baseline at 12 months ]
    Assessed by using cognitive instrument testing

  22. Change in Stroop color naming [ Time Frame: Baseline, 6 month, 12 month ]
    Using cognitive instrument testing

  23. Change in blood pressure [ Time Frame: Change from baseline at 12 months ]
    Assessed by usingSphygmomanometer

  24. Change in biochemical marker for bone turnover and bone metabolism [ Time Frame: Change from baseline at 12 months ]
    Assessed by using enzyme linked immunosorbent assay and radioimmunoassay

  25. Change in cardio metabolic risk factors [ Time Frame: Change from baseline at 12 months ]
    Assessed by measuring metabolic syndrome components

  26. Change in physical activity [ Time Frame: Change from baseline at 12 months ]
    Assessed by using the 7 day Stanford physical activity questionnaire

  27. Change in central volumetric BMD [ Time Frame: Change from baseline at 12 months ]
    Assessed by using CT scan at the spine and hip

  28. Change in waist circumference [ Time Frame: Change from baseline at 12 months ]
    Assessed by using tape measurement

  29. Change in lean mass [ Time Frame: Change from baseline at 12 months ]
    Assessed by using dual-energy x-ray absorptiometry

  30. Change in Trail A/B [ Time Frame: Baseline, 6 month, 12 month ]
    Assessed by usingcognitive instrumental testing

  31. Change in fat mass [ Time Frame: Change from baseline at 12 months ]
    Assessed by using dual-energy x-ray absorptiometry

  32. Change in visceral fat [ Time Frame: Change from baseline at 12 months ]
    Assessed by using dual-energy x-ray absorptiometry

  33. Change in physical activity using accelerometer [ Time Frame: Change from baseline at 12 months ]
    Assessed by using an accelerometer

  34. Change in body weight [ Time Frame: Change from baseline at 12 months ]
    Assessed by using weighing scale

  35. Change in sclerostin [ Time Frame: Change from baseline at 12 months ]
    Assessed by using enzyme linked immunoassay

  36. Change in wnt signaling pathways [ Time Frame: Change from baseline at 12 months ]
    Assessed by measurements of circulating levels of Wnt 5a and Sfrp5

  37. Change in total body mass [ Time Frame: Change from baseline at 12 months ]
    Assessed byusing dual energy x-ray absorptiometry

  38. Change in hormones [ Time Frame: Change from baseline at 12 months ]
    Assessed by usingenzyme link immunoassay

  39. Change in thigh mass [ Time Frame: Change from baseline at 12 months ]
    Assessed by using CT scan

  40. Change in circulating cytokines [ Time Frame: Change from baseline at 12 months ]
    Assessed by using enzyme linked immunoassay

  41. Change in adipocytokines [ Time Frame: Change from baseline at 12 months ]
    Assessed by using enzyme linked immunoassay

  42. Change in total volumetric BMD [ Time Frame: Change from baseline at 12 months ]
    Assessed by using QCT Pro software

  43. Change in cortical trabecular BMD [ Time Frame: Change from baseline at 12 months ]
    Assessed by using QCT Pro software

  44. Change in aerobic capacity [ Time Frame: Change from baseline at 12 months ]
    Assessed by using indirect calorimetry during graded treadmill test



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 65 - 85 years • BMI 30 - 40 kg/m2 • Stable body weight (±2 kg) during the past 6 months • Sedentary (regular exercise <1 h/wk. or <2 x/wk. for the last 6 months) • Willing to provide informed consent

Exclusion Criteria:

  • Failure to provide informed consent.
  • Any major chronic diseases, or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restrictions are contraindicated, or that would interfere with interpretation of results

    • Cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease (e.g., New York Heart Class III or IV congestive heart failure, severe pulmonary disease requiring steroid pills or the use of supplemental oxygen ) that would contraindicate exercise or dietary restriction
    • Severe orthopedic (e.g. awaiting joint replacement) and/or neuromuscular (e.g. multiple sclerosis, amyotrophic lateral sclerosis, active rheumatoid arthritis) disease or impairments that would contraindicate participation in exercise
    • Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention (e.g. renal failure on hemodialysis, severe psychiatric disorder [e.g. bipolar, schizophrenia], excess alcohol use [more than14 drinks per week])
    • Severe visual or hearing impairments that would interfere with following directions
    • Significant cognitive impairment, defined as a known diagnosis of dementia or positive screening test for dementia using the Mini-Mental State Exam score less than 24)
    • Uncontrolled hypertension (BP>160/90 mm Hg)
    • History of malignancy during the past 5 years (except non-melanoma skin cancers)
    • Current use of bone acting drugs (e.g. use of estrogen, or androgen containing compound, raloxifene, calcitonin, parathyroid hormone during the past year or bisphosphonates during the last two years)
    • Osteoporosis (T-score -2.5 and below on hip or spine scan) or history of fragility fractures − Diabetes mellitus requiring insulin for treatment or with a fasting blood glucose of >140 mg/dl, and/or HbA1c >8.5% (Those excluded from the study because of fasting blood glucose of >140 mg/dl or HbA1c>8.5% will be referred to their primary care provider for follow-up and appropriate treatment).
    • Terminal illness with life expectancy less than 12 months, as determined by a physician
    • Use of any drugs or natural products designed to induce weight loss within past three months.
    • Positive exercise stress test for ischemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329963


Contacts
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Contact: Dennis T Villareal, MD 7137947156 dennis.villareal@bcm.edu
Contact: Arjun Paudyal, MS 713 578 4300 arjun.paudyal@bcm.edu

Locations
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United States, Texas
Michael E Debakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Dennis Villareal, MD    713-794-7156    dennis.villareal@bcm.edu   
Contact: Arjun Paudyal, MS    713 578 4300    arjun.paudyal@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Michael Debakey Veterans Affairs Medical Center
Biomedical Research Institute of New Mexico
Investigators
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Principal Investigator: Dennis T Villareal, MD Baylor College of Medicine

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Responsible Party: Dennis T. Villareal, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03329963     History of Changes
Other Study ID Numbers: H-40373
R01DK109950 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No