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

NCT05437406 | Active Not Recruiting DMC

• 2 other identifiers: 8017321P50MD017344-01
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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 caregiver support (PBT-AC), compared with health education (HE).

Conditions

Childhood Obesity; Minority Health

Keywords

obesity; treatment; intervention; behavioral treatment; parent based treatment; Hispanic; Latino; children

Outcome Measures

Primary Outcomes (1)

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

  age and sex adjusted BMI (kg/m\^2)

  Change from baseline to month 3, 6, 12, and 18

Secondary Outcomes (12)

• Parent body mass index (BMI) as measured by height and weight

  Change from baseline to month 3, 6, 12, and 18

• Child HgbA1c levels as measured by blood collection

  Change from baseline to month 6, 12, and 18

• Child lipid (e.g., cholesterol) levels as measured by blood collection

  Change from baseline to month 6, 12, and 18

• Child dietary intake as measured by 2, 24-hour dietary recalled obtained from the primary parent

  Change from baseline to month 6, 12, and 18

• Parent dietary intake as measured by the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool

  Change from baseline to month 6, 12, and 18

Study Arms (2)

PBT-AC

EXPERIMENTAL

PBT-AC includes the elements of family based behavioral treatment for obesity, delivered exclusively to caregivers as the agents of change, via telehealth.

Behavioral: Parent-based treatment- All caregivers (PBT-AC)

Health Education

ACTIVE COMPARATOR

This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress via telehealth.

Behavioral: Health Education (HE)

Interventions

Parent-based treatment- All caregivers (PBT-AC) BEHAVIORAL

PBT-AC provides all the elements of FBT, including nutrition and physical activity education, behavior therapy skills, and parenting skills.

Also known as: parent based treatment, family based behavioral treatment

PBT-AC

Health Education (HE) BEHAVIORAL

The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

Health Education

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• University of California, San Diego: lead
• University of Southern California: collaborator

Study Sites (1)

UC San Diego Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, 92037, United States

Location

Related Publications (1)

• Boutelle KN, Eichen DM, Manzano M, Crespo NC, Rivera-Iniguez I, Castro E, Strong DR, Newell I, Reed K, Marquez B, Rhee KE. Design of the FRESH-LC study: Caregivers as the agent of change for childhood obesity and chronic disease risk among Latino families. Contemp Clin Trials. 2026 Feb;161:108191. doi: 10.1016/j.cct.2025.108191. Epub 2025 Dec 16.

  PMID: 41412474 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kerri Boutelle, Ph.D.

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Psychiatry, and Herbert Wertheim School of Public Health and Human Longevity Science

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 29, 2022
• Study Start: September 8, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

US (1)