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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
No Placebo-Only Group
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 belowSelect...
I am between 65 and 85 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe heart or lung conditions that would prevent me from exercising or dieting.
Select...
I have osteoporosis or have had fractures from minor injuries.
Select...
I do not have major health or psychiatric issues that would stop me from joining an exercise program.
Select...
I have diabetes needing insulin or my blood sugar/HbA1c levels are high.
Select...
I do not have severe vision or hearing problems that make it hard for me to follow instructions.
Select...
I have severe joint, muscle, or nerve conditions that prevent me from exercising.
Select...
I have not had cancer in the last 5 years, except for non-melanoma skin cancers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 12 months
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 moreSide effects data
From 2008 Phase 2 trial • 114 Patients • NCT0015141135%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,028 Previous Clinical Trials
6,030,042 Total Patients Enrolled
35 Trials studying Obesity
15,870 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,333 Total Patients Enrolled
472 Trials studying Obesity
590,894 Patients Enrolled for Obesity
Michael E. DeBakey VA Medical CenterFED
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114 Patients Enrolled for Obesity
Biomedical Research Institute of New MexicoOTHER
10 Previous Clinical Trials
2,147 Total Patients Enrolled
2 Trials studying Obesity
1,030 Patients Enrolled for Obesity
Dennis T Villareal, MDPrincipal InvestigatorBaylor College of Medicine
10 Previous Clinical Trials
570 Total Patients Enrolled
4 Trials studying Obesity
269 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe heart or lung conditions that would prevent me from exercising or dieting.I have osteoporosis or have had fractures from minor injuries.I do not have major health or psychiatric issues that would stop me from joining an exercise program.I haven't used weight loss products in the last 3 months.I have diabetes needing insulin or my blood sugar/HbA1c levels are high.I have not used any bone-targeting drugs in the past year or bisphosphonates in the last two years.I do not have severe vision or hearing problems that make it hard for me to follow instructions.I have severe joint, muscle, or nerve conditions that prevent me from exercising.I don't have chronic diseases that would affect my ability to follow diet or exercise plans.I am between 65 and 85 years old.I have not had cancer in the last 5 years, except for non-melanoma skin cancers.
Research Study Groups:
This trial has the following groups:- Group 1: Lifestyle intervention Group
- Group 2: Healthy lifestyle intervention Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT03329963 — N/A