Family, Responsibility, Education, Support, and Health for Latino Caregivers (FRESH-LC)
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 caregiver support (PBT-AC), compared with health education (HE).
Conditions:
🦠 Childhood Obesity 🦠 Minority Health
🗓️ Study Start (Actual) 8 September 2022
🗓️ Primary Completion (Estimated) October 2026
✅ Study Completion (Estimated) October 2026
👥 Enrollment (Estimated) 160
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 La Jolla, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 5 Years to 12 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 14 June 2022
  • First Submitted that Met QC Criteria 24 June 2022
  • First Posted 29 June 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 April 2024
  • Last Update Posted 30 April 2024
  • Last Verified April 2024