Status:
ACTIVE_NOT_RECRUITING
Family, Responsibility, Education, Support, and Health for Latino Caregivers (FRESH-LC)
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
University of Southern California
Children's Hospital Los Angeles
Conditions:
Childhood Obesity
Minority Health
Eligibility:
All Genders
5-12 years
Phase:
NA
Brief Summary
The objective of this proposed study is to collect initial efficacy data on a telehealth family-based behavioral program for Latino children with overweight or obesity, which also includes additional ...
Detailed Description
The study will compare the efficacy of PBT-AC and health education program delivered via telehealth on child weight loss. Investigators will provide 6 months of a group program (PBT-AC or HE) and will...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- A child with overweight/obesity (85% BMI and above for age) aged 5 to 12 years
- Primary parent who is responsible for food preparation willing to participate and complete all assessments
- At least one other caregiver who is over 18 years of age (parent, grandparent, other close family member, friend or child care provider) who is willing to commit to attending at least 50% of all treatment visits
- Parent and caregiver can read Spanish or English at a minimum of a 5th grade level, and willing to participate in a group setting in Spanish or English together
- Parent and Child is on a stable medication regimen (minimum of 3 months) for anything that could impact weight.
- Parent and caregiver have access to a device that can facilitate zoom meetings. If the parent and caregiver do not have access to a device, the family will be provided with such.
- Family must plan to remain in the San Diego or surrounding areas within the time frame of the study
- One of the parent or caregivers identifies as Hispanic/Latino
- Exclusion Criteria
- 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
- Child with a severe behavioral or psychiatric disorder that would interfere with treatment (e.g., conduct disorder, severe depression, significant autism spectrum disorder)
- Acute parent or caregiver psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, bipolar, borderline personality disorder, moderate or severe alcohol or substance use disorder) that could interfere with treatment
- Inability to participate in physical activity due to significant disability
- First degree relative or someone in the household with anorexia or bulimia
- Parent is pregnant or planning on becoming pregnant during the duration of the study
- Parent has had bariatric surgery less than 6 months ago and/or is not yet eating solid food post-surgery, or is planning to have a bariatric surgery over the course of study participation (18 months)
- Parent or child are taking insulin for Type II Diabetes
- Parent or child are taking weight loss medications
Exclusion
Key Trial Info
Start Date :
September 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2026
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT05437406
Start Date
September 8 2022
End Date
October 1 2026
Last Update
April 1 2025
Active Locations (1)
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1
UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, United States, 92037