Status:
COMPLETED
Lifestyle Intervention to Improve Bone Quality
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Michael E. DeBakey VA Medical Center
Conditions:
Aging
Obesity
Eligibility:
All Genders
65-85 years
Phase:
NA
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 Lif...
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/quali...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03329963
Start Date
November 9 2017
End Date
January 16 2023
Last Update
June 6 2025
Active Locations (1)
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1
Michael E Debakey VA Medical Center
Houston, Texas, United States, 77030