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Behavioral Intervention
Family-Based Intervention for Childhood Obesity
N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline
Awards & highlights
Study Summary
This trial will test a family-based intervention to reduce childhood obesity in Latino families by incorporating strategies like phones and cultural elements like familism and language.
Who is the study for?
This trial is for Latino families with a child aged 2-5 who's overweight, defined by BMI>85% for their age and sex. Caregivers must spend at least 20 hours per week with the child, be willing to participate in the study activities, and complete data collection protocols. They should speak Spanish or English. Those caring for children on weight loss meds or programs, or with conditions like Prader-Willi Syndrome are excluded.Check my eligibility
What is being tested?
The trial tests a family-based obesity intervention tailored for Latino families that combines in-person strategies with mobile technology and considers cultural factors like familism. It aims to promote healthy behaviors and reduce childhood obesity/cardiovascular risk disparities among Latinos.See study design
What are the potential side effects?
Since this is a behavioral intervention focusing on diet, physical activity, and education rather than medication, there may not be direct side effects as seen with drugs; however participants might experience lifestyle adjustment challenges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; change in baseline and 1-month post baseline, change in baseline and 6-months post baseline, and change in baseline and 12-month post baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Child BMI
Secondary outcome measures
Caregiver Physical Activity Patterns
Caregiver/parent BMI
Caregiver/parent dietary intake
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
The study's intervention is a parenting/caregiver training program that includes 1-month of weekly in-person sessions plus multi-media interactive text messaging. The weekly 1-hour-in-person sessions will be coupled with four interactive messages per week for a period of 4 weeks total, followed by "booster" text messages after completing the 4-week program.
Group II: Usual CareActive Control1 Intervention
"Usual care" for caregivers of 2- to-5-year-olds will include the Women Infant and Children services : (1) monthly vouchers for nutritious food; (2) individual nutrition counseling at least twice per year; (3) nutrition education two times per year (1:1 counseling or online health education modules); and (4) referrals to family services.
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,532 Previous Clinical Trials
10,265,086 Total Patients Enrolled
University of California, MercedOTHER
17 Previous Clinical Trials
5,939 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a caregiver willing and able to join the study as determined by an assessment.I care for a child with a condition causing overweight, like Prader-Willi Syndrome.I care for a child aged 2-5 who is overweight.I am a caregiver of a child in a weight loss program.I care for a young child for at least 20 hours a week.I am a caregiver willing to follow the study's data collection schedule.I am an adult caregiver of a young child who speaks Spanish or English.I am a caregiver of a child on weight loss medication.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Usual Care
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.
Is the enrollment period for this experiment still open?
"According to clinicaltrials.gov, this experiment is no longer actively recruiting patients. It was initially posted on September 1st 2023 before being updated for the last time in November 15th 2022. Despite not needing any further volunteers, 1007 other medical studies are currently looking for enrolment from willing participants."
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