← Back to Search

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to month 3, 6, 12, and 18

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaOTHER

906 Previous Clinical Trials

1,596,128 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,716 Total Patients Enrolled

University of California, San DiegoLead Sponsor

1,121 Previous Clinical Trials

1,520,764 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial enrolling geriatric participants?

"As outlined in the criteria for participation, only those under 10 years old and above 5 can partake in this trial."

Answered by AI

Are there any participants still needed for this experiment?

"This clinical trial is actively seeking participants, as per the most up-to-date information on clinicaltrials.gov. This research project was first announced to the public on September 8th 2022 and has been amended for accuracy since November 1st of that same year."

Answered by AI

Who meets the criteria for eligibility in this investigation?

"This medical study is accepting approximately 160 candidates that meet the criteria of being between 5 and 10 years old, as well as belonging to a minority health."

Answered by AI

What is the current enrollment figure for this trial?

"Affirmative. According to the information on clinicaltrials.gov, this research is seeking participants as of now. This investigation was first made available for enrollment on September 8th 2022 and has been amended most recently on November 1st 2022. 160 people are needed from one medical facility in order to meet study requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Family, Responsibility, Education, Support, and Health for Latino Caregivers (FRESH-LC)

Kerri Boutelle 2022. "Family, Responsibility, Education, Support, and Health for Latino Caregivers (FRESH-LC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05437406.

All > Intervention