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Behavioral Intervention

Behavioral Therapy + Support for Caregivers for Childhood Obesity (FRESH-LC Trial)

N/A
Recruiting
Led By Kerri Boutelle, Ph.D.
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary parent responsible for food preparation willing to participate and complete all assessments
Child with overweight/obesity (85% BMI and above for age) aged 5 to 12 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to month 3, 6, 12, and 18
Awards & highlights

FRESH-LC Trial Summary

This trial will compare a new telehealth program that includes behavioral therapy and support for caregivers to health education in Latino children with overweight or obesity.

Who is the study for?
The FRESH-LC trial is for Latino families in the San Diego area with children aged 5-12 who are overweight or obese. It requires a primary caregiver and another adult willing to attend sessions, both able to read Spanish or English at a 5th grade level. Participants must have stable medication regimens and access to Zoom-capable devices.Check my eligibility
What is being tested?
This study tests a telehealth family-based behavioral program aimed at managing childhood obesity among Latinos (PBT-AC), against standard health education (HE). The focus is on providing support for caregivers and promoting healthy behaviors within the family unit.See study design
What are the potential side effects?
Since this trial involves educational interventions rather than medications, traditional side effects are not expected. However, participants may experience changes in lifestyle habits which could include increased physical activity discomfort or dietary adjustments.

FRESH-LC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am the main person who prepares food at home and agree to complete all required assessments.
Select...
My child is overweight or obese for their age.

FRESH-LC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to month 3, 6, 12, and 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to month 3, 6, 12, and 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Child anthropometric change as measured by age and sex adjusted body mass index (BMIz)
Secondary outcome measures
Child HgbA1c levels as measured by blood collection
Child dietary intake as measured by 2, 24-hour dietary recalled obtained from the primary parent
Child eating behavior as measured by the Child Eating Behavioral Questionnaire (CEBQ)
+9 more

FRESH-LC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PBT-ACExperimental Treatment1 Intervention
PBT-AC includes the elements of family based behavioral treatment for obesity, delivered exclusively to caregivers as the agents of change, via telehealth.
Group II: Health EducationActive Control1 Intervention
This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress via telehealth.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaOTHER
917 Previous Clinical Trials
1,611,355 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,723 Previous Clinical Trials
7,495,571 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,130 Previous Clinical Trials
1,550,981 Total Patients Enrolled

Media Library

Parent-based treatment- All caregivers (PBT-AC) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05437406 — N/A
Childhood Obesity Research Study Groups: PBT-AC, Health Education
Childhood Obesity Clinical Trial 2023: Parent-based treatment- All caregivers (PBT-AC) Highlights & Side Effects. Trial Name: NCT05437406 — N/A
Parent-based treatment- All caregivers (PBT-AC) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05437406 — N/A
~90 spots leftby Oct 2026
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