← 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

Must not have

Child diagnosis of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and/or exercise is needed

Parent or child are taking insulin for Type II Diabetes

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My child has a chronic illness like cystic fibrosis or type 1 diabetes that requires a doctor's supervision for diet or exercise.

Select...

My child or I am taking insulin for Type II Diabetes.

Select...

I cannot do physical activities because of a major disability.

Select...

My child or I am taking medication for weight loss.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Child anthropometric change as measured by age and sex adjusted body mass index (BMIz)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met