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Healthy Lifestyle Intervention for Bone Health (LIMB-Q Trial)

N/A
Waitlist Available
Led By Dennis T Villareal, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 65 - 85 years
Be older than 65 years old
Must not have
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
Osteoporosis (T-score -2.5 and below on hip or spine scan) or history of fragility fractures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 12 months
Awards & highlights

Summary

This trial will help researchers understand how best to help obese older adults maintain healthy bones.

Who is the study for?
This trial is for obese older adults aged 65-85 with a BMI of 30-40 who are sedentary and have had a stable body weight in the last six months. It's not for those with osteoporosis, severe diseases that limit exercise, cognitive impairments, uncontrolled hypertension, recent cancer (except skin), or on certain medications.
What is being tested?
The study compares two groups: one follows a healthy lifestyle intervention while the other engages in both diet and exercise changes for one year. The goal is to see how these interventions affect bone strength and quality in aging individuals.
What are the potential side effects?
While specific side effects aren't listed, lifestyle interventions may include muscle soreness from new exercises, potential dietary adjustment issues like gastrointestinal discomforts, and possible stress related to behavioral changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 65 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe heart or lung conditions that would prevent me from exercising or dieting.
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I have osteoporosis or have had fractures from minor injuries.
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I do not have major health or psychiatric issues that would stop me from joining an exercise program.
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I have diabetes needing insulin or my blood sugar/HbA1c levels are high.
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I do not have severe vision or hearing problems that make it hard for me to follow instructions.
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I have severe joint, muscle, or nerve conditions that prevent me from exercising.
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I have not had cancer in the last 5 years, except for non-melanoma skin cancers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in cortical thickness
Change in femoral bone strength
Secondary study objectives
Change in Ray Auditory verbal learning test
Change in adipocytokines
Change in aerobic capacity
+37 more

Side effects data

From 2008 Phase 2 trial • 114 Patients • NCT00151411
35%
Diarrhea
22%
headache/migraine
22%
common cold/respiratory tract infection
16%
nausea and/or vomiting
15%
flu
13%
dysmenorrhea/cramps
11%
stomach/abdominal pain or discomfort
9%
musculoskeletal
5%
vaginal infection
5%
dizziness
5%
hair loss
5%
dental issues
4%
fatigue
4%
flatulence
2%
bladder infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Metformin

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Lifestyle intervention GroupExperimental Treatment1 Intervention
Behavioral therapy for weight loss and Exercise Training
Group II: Healthy lifestyle intervention GroupActive Control1 Intervention
Group education sessions that focus on diet exercise and social support.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle Intervention
2001
Completed Phase 3
~8370

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,018 Previous Clinical Trials
6,031,309 Total Patients Enrolled
35 Trials studying Obesity
15,870 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,771 Total Patients Enrolled
459 Trials studying Obesity
589,430 Patients Enrolled for Obesity
Michael E. DeBakey VA Medical CenterFED
66 Previous Clinical Trials
17,111 Total Patients Enrolled
1 Trials studying Obesity
114 Patients Enrolled for Obesity

Media Library

Healthy Lifestyle Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03329963 — N/A
Obesity Research Study Groups: Lifestyle intervention Group, Healthy lifestyle intervention Group
Obesity Clinical Trial 2023: Healthy Lifestyle Intervention Highlights & Side Effects. Trial Name: NCT03329963 — N/A
Healthy Lifestyle Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03329963 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT03329963 — N/A
~4 spots leftby Dec 2024
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