Lifestyle Intervention to Improve Bone Quality (LIMB-Q)

June 4, 2025 updated by: Dennis T. Villareal, Baylor College of Medicine

Does Lifestyle Intervention Improve Bone Quality in Obese Older Adults?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E DeBakey VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 65 - 85 years • BMI 30 kg/m2 or more• 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor College of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Michael E. DeBakey VA Medical Center
Biomedical Research Institute of New Mexico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dennis T Villareal, MD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-40373
  • R01DK109950 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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