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Behavioral Intervention
Lifestyle Intervention for Preventing Type 2 Diabetes in Latinos
N/A
Recruiting
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Children with obesity, defined as BMI ≥ 95th percentile for age and sex
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Study Summary
This trial will test a lifestyle intervention to see if it can reduce type 2 diabetes risk factors and increase quality of life among high-risk Latino families.
Who is the study for?
This trial is for Latino families with children aged 10-16 who are obese, meaning their BMI is at or above the 95th percentile. Parents and children must not be enrolled in any diabetes prevention or weight loss program recently and should not have type 2 diabetes or conditions affecting metabolism.Check my eligibility
What is being tested?
The study tests a lifestyle intervention aimed at reducing risk factors for type 2 diabetes and improving quality of life among high-risk Latino families. It focuses on diet, exercise, and other daily habits to prevent diabetes.See study design
What are the potential side effects?
Since this is a lifestyle intervention focusing on diet and exercise rather than medication, side effects may include muscle soreness from new physical activities or changes in digestion due to dietary adjustments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is considered obese based on their BMI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glucose Tolerance
Secondary outcome measures
Dietary behaviors
Physical Activity
Bone and Bones
+3 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
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Lifestyle InterventionExperimental Treatment1 Intervention
16-week family-focused intervention that includes nutrition education, behavioral change skills training, and physical activity.
Group II: Comparison controlActive Control1 Intervention
Comparison control families meet with the Study Physician and a Registered Dietitian as a family to review laboratory results and receive lifestyle counseling. Control families will be contacted on a monthly basis for a total of 12 months.
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?
Phoenix Children's HospitalOTHER
74 Previous Clinical Trials
5,013,883 Total Patients Enrolled
St. Vincent de Paul Medical and Dental ClinicOTHER
2 Previous Clinical Trials
152 Total Patients Enrolled
University of WashingtonOTHER
1,743 Previous Clinical Trials
1,847,738 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child has a mental health condition that affects their daily life.I am a Latino child aged between 10 and 16 years.Parents who identify themselves as American Indian.My child is on medication or has a condition affecting their sugar levels, physical activity, or thinking.My child is considered obese based on their BMI.My child has type 2 diabetes according to the American Diabetes Association.Children who identify as American Indian.Kids who are currently in or have been in a program to prevent diabetes or lose weight in the past year.Your parents have been in a diabetes prevention or weight loss program in the past year.You consider yourself to be American Indian.You identify as Latino based on your self-report.It seems like "Inclusion" is a fragment of a sentence. Could you please provide more context or clarify?
Research Study Groups:
This trial has the following groups:- Group 1: Comparison control
- Group 2: Lifestyle Intervention
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have enrolled in this clinical experiment?
"Absolutely. Clinicaltrials.gov confirms that this clinical experiment, which was originally written on December 12th 2021, is actively searching for participants. 132 individuals are being accepted at a single site."
Answered by AI
Do I fit the requirements to enter this scientific evaluation?
"The criteria for admittance into this clinical trial is pediatric obesity, and an age range of 10-99 years old. An approximate 132 individuals are being accepted as participants in the study."
Answered by AI
Is this research available to the public at present?
"Affirmative. The information available on clinicaltrials.gov verifies that this scientific trial, established December 12th 2021, is actively engaging participants in recruitment efforts. A total of 132 volunteers are necessary from just one medical facility."
Answered by AI
Is the study open to geriatric patients?
"This clinical trial allows for participation between the ages of 10 and 99, as per its inclusion criteria."
Answered by AI
Who else is applying?
What site did they apply to?
Arizona State University
What portion of applicants met pre-screening criteria?
Did not meet criteria
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