- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03329963
Lifestyle Intervention to Improve Bone Quality (LIMB-Q)
Does Lifestyle Intervention Improve Bone Quality in Obese Older Adults?
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Belen Segoviano-Escobar, MS
- Phone Number: 713 578 4300
- Email: belen.segoviano-escobar@bcm.edu
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- Michael E DeBakey VA Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle intervention Group
Behavioral therapy for weight loss and Exercise Training
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cortical thickness
Time Frame: Change from baseline at 12 months
|
Assessed by using high-resolution peripheral computed tomography (HR-pQCT)
|
Change from baseline at 12 months
|
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)
|
Change from baseline at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in bone material strength
Time Frame: Change from baseline at 12 months
|
Assessed by using microindentation testing
|
Change from baseline at 12 months
|
Change in lower extremity strength
Time Frame: Change from baseline at 12 months
|
Assessed by using a Biodex dynamometer
|
Change from baseline at 12 months
|
Change in physical performance test
Time Frame: Change from baseline at 12 months
|
assessed by using the objective physical performance test
|
Change from baseline at 12 months
|
Change in gait speed
Time Frame: Change from baseline at 12 months
|
as measured by completing the time to walk a certain distance
|
Change from baseline at 12 months
|
Change in handgrip strength
Time Frame: Change from baseline at 12 months
|
Measured by hydraulic hand dynamometer
|
Change from baseline at 12 months
|
Change in trabecular thickness
Time Frame: Change from baseline at 12 months
|
Assessed by using HR-pQCT
|
Change from baseline at 12 months
|
Change in areal bone mineral density (BMD)
Time Frame: Change from baseline at 12 months
|
Assessed by using dual-energy x-ray absorptiometry
|
Change from baseline at 12 months
|
Change in trabecular number
Time Frame: Change from baseline at 12 month
|
Assessed by using HR-pQCT
|
Change from baseline at 12 month
|
Change in total volumetric BMD
Time Frame: Change from baseline at 12 months
|
Assessed by using HR-pQCT
|
Change from baseline at 12 months
|
Change in cortical volumetric BMD
Time Frame: Change from baseline at 12 months
|
Assessed by using HR-pQCT
|
Change from baseline at 12 months
|
Change in trabecular volumetric BMD
Time Frame: Change from baseline at 12 months
|
Assessed by using HR-pQCT
|
Change from baseline at 12 months
|
Change in stiffness
Time Frame: Change from baseline at 12 months
|
Assessed by using HR-pQCT
|
Change from baseline at 12 months
|
Change in trabecular separation
Time Frame: Change from baseline at 12 months
|
Assessed by using HR-pQCT
|
Change from baseline at 12 months
|
Change in micro-finite element analyses strength
Time Frame: Change from baseline at 12 months
|
Assessed by using HR-pQCT
|
Change from baseline at 12 months
|
Change in cortical porosity
Time Frame: Change from baseline at 12 months
|
Assessed by using HR-pQCT
|
Change from baseline at 12 months
|
Change in general quality of life
Time Frame: Change from baseline at 12 months
|
Assessed by using the Short Form-36 questionnaire
|
Change from baseline at 12 months
|
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
|
Change from baseline at 12 months
|
Change in mood
Time Frame: Change from baseline at 12 months
|
Assessed by using a mood scale questionnaire
|
Change from baseline at 12 months
|
Change in composite cognitive z-score
Time Frame: Change from baseline at 12 months
|
Using cognitive instrument testing
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Change from baseline at 12 months
|
Change in cardio metabolic risk factors
Time Frame: Change from baseline at 12 months
|
Assessed by measuring metabolic syndrome components
|
Change from baseline at 12 months
|
Change in word list fluency
Time Frame: Change from baseline at 12 months
|
Assessed by using cognitive instrument testing
|
Change from baseline at 12 months
|
Change in Ray Auditory verbal learning test
Time Frame: Change from baseline at 12 months
|
Assessed by using cognitive instrument testing
|
Change from baseline at 12 months
|
Change in blood pressure
Time Frame: Change from baseline at 12 months
|
Assessed by usingSphygmomanometer
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Change from baseline at 12 months
|
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
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Change from baseline at 12 months
|
Change in central volumetric BMD
Time Frame: Change from baseline at 12 months
|
Assessed by using CT scan at the spine and hip
|
Change from baseline at 12 months
|
Change in waist circumference
Time Frame: Change from baseline at 12 months
|
Assessed by using tape measurement
|
Change from baseline at 12 months
|
Change in lean mass
Time Frame: Change from baseline at 12 months
|
Assessed by using dual-energy x-ray absorptiometry
|
Change from baseline at 12 months
|
Change in fat mass
Time Frame: Change from baseline at 12 months
|
Assessed by using dual-energy x-ray absorptiometry
|
Change from baseline at 12 months
|
Change in visceral fat
Time Frame: Change from baseline at 12 months
|
Assessed by using dual-energy x-ray absorptiometry
|
Change from baseline at 12 months
|
Change in physical activity using accelerometer
Time Frame: Change from baseline at 12 months
|
Assessed by using an accelerometer
|
Change from baseline at 12 months
|
Change in body weight
Time Frame: Change from baseline at 12 months
|
Assessed by using weighing scale
|
Change from baseline at 12 months
|
Change in sclerostin
Time Frame: Change from baseline at 12 months
|
Assessed by using enzyme linked immunoassay
|
Change from baseline at 12 months
|
Change in wnt signaling pathways
Time Frame: Change from baseline at 12 months
|
Assessed by measurements of circulating levels of Wnt 5a and Sfrp5
|
Change from baseline at 12 months
|
Change in total body mass
Time Frame: Change from baseline at 12 months
|
Assessed byusing dual energy x-ray absorptiometry
|
Change from baseline at 12 months
|
Change in hormones
Time Frame: Change from baseline at 12 months
|
Assessed by usingenzyme link immunoassay
|
Change from baseline at 12 months
|
Change in thigh mass
Time Frame: Change from baseline at 12 months
|
Assessed by using CT scan
|
Change from baseline at 12 months
|
Change in circulating cytokines
Time Frame: Change from baseline at 12 months
|
Assessed by using enzyme linked immunoassay
|
Change from baseline at 12 months
|
Change in adipocytokines
Time Frame: Change from baseline at 12 months
|
Assessed by using enzyme linked immunoassay
|
Change from baseline at 12 months
|
Change in total volumetric BMD
Time Frame: Change from baseline at 12 months
|
Assessed by using QCT Pro software
|
Change from baseline at 12 months
|
Change in cortical trabecular BMD
Time Frame: Change from baseline at 12 months
|
Assessed by using QCT Pro software
|
Change from baseline at 12 months
|
Change in aerobic capacity
Time Frame: Change from baseline at 12 months
|
Assessed by using indirect calorimetry during graded treadmill test
|
Change from baseline at 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dennis T Villareal, MD, Baylor College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-40373
- R01DK109950 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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