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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 12 months
Awards & highlights
LIMB-Q Trial 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.Check my eligibility
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.See study design
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.
LIMB-Q Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 65 and 85 years old.
LIMB-Q Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in cortical thickness
Change in femoral bone strength
Secondary outcome measures
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
LIMB-Q 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 2
~8880
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,001,832 Total Patients Enrolled
35 Trials studying Obesity
15,986 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,066 Total Patients Enrolled
446 Trials studying Obesity
588,818 Patients Enrolled for Obesity
Michael E. DeBakey VA Medical CenterFED
64 Previous Clinical Trials
15,668 Total Patients Enrolled
1 Trials studying Obesity
114 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can I enroll in this experiment?
"Candidates with obesity aged between 65 and 85 qualify for consideration in this medical trial, which is recruiting a total of 120 patients."
Answered by AI
What primary goals are investigators hoping to achieve through this experiment?
"This research aims to ascertain alterations in cortical thickness over the span of 12 months. Secondary objectives include gauging changes in waist circumference (measured with a tape measure), shifts in mood as determined by questionnaire, and modifications in cognitive abilities assessed via mini-mental exams."
Answered by AI
Are there still opportunities to take part in this research endeavor?
"As per clinicaltrials.gov, this medical trial is actively recruiting participants. It was first shared on November 1st 2017 and the most recent update occurred on January 20th 2022."
Answered by AI
Is the eligibility for this research program restricted to those aged 30 or younger?
"This trial stipulates that individuals must be between 65 and 85 years old to meet the inclusion criteria."
Answered by AI
How many people are participating in this medical research project?
"Correct. According to clinicaltrials.gov, this medical study is still enrolling participants after being initially posted on November 1st 2017 and most recently updated on January 20th 2022. A total of 120 patients are sought from a single trial site."
Answered by AI
Who else is applying?
What state do they live in?
California
Texas
What site did they apply to?
Michael E Debakey VA Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
3+
0
Why did patients apply to this trial?
I have tried most of the drugs and nothing works. I've tried other things that did not help. I am hoping you're treatment will help me.
PatientReceived 1 prior treatment
If it week help me create a lifestyle to help lose weight and be healthy then that's great.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long is the study and what does it entail?
PatientReceived 2+ prior treatments
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