Lifestyle Intervention to Improve Bone Quality

NCT03329963 | Completed DMC

• 2 other identifiers: H-40373R01DK109950
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Obesity

Outcome Measures

Primary Outcomes (2)

• Change in cortical thickness

  Assessed by using high-resolution peripheral computed tomography (HR-pQCT)

  Change from baseline at 12 months

• Change in femoral bone strength

  Assessed by using finite element analyses (FEA) of quantitative computed tomography (QCT)

  Change from baseline at 12 months

Secondary Outcomes (41)

• Change in bone material strength

  Change from baseline at 12 months

• Change in lower extremity strength

  Change from baseline at 12 months

• Change in physical performance test

  Change from baseline at 12 months

• Change in gait speed

  Change from baseline at 12 months

• Change in handgrip strength

  Change from baseline at 12 months

Study Arms (2)

Lifestyle intervention Group

EXPERIMENTAL

Behavioral therapy for weight loss and Exercise Training

Behavioral: Lifestyle Intervention

Healthy lifestyle intervention Group

ACTIVE COMPARATOR

Group education sessions that focus on diet exercise and social support.

Behavioral: Healthy Lifestyle Intervention

Interventions

Healthy Lifestyle Intervention BEHAVIORAL

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.

Healthy lifestyle intervention Group

Lifestyle Intervention BEHAVIORAL

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.

Lifestyle intervention Group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Michael E. DeBakey VA Medical Center: collaborator
• Biomedical Research Institute of New Mexico: collaborator

Study Sites (1)

Michael E Debakey VA Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Gregori G, Mediwala S, Liebschner M, Kim D, Bryant MS, Klonis N, Armamento-Villareal R, Qualls C, Villareal DT. Bone quality response to lifestyle intervention in older adults with obesity (LIMB-Q trial): a randomised controlled trial. Lancet Healthy Longev. 2025 Sep;6(9):100761. doi: 10.1016/j.lanhl.2025.100761. Epub 2025 Sep 18.

  PMID: 40976254 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dennis T Villareal, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 6, 2017
• Study Start: November 9, 2017
• Primary Completion: January 16, 2023
• Study Completion: January 16, 2023
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)