NCT05437406

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

Caregivers as the Agent of Change for Childhood Obesity and Chronic Disease Risk Among Latino Families

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

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).

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 follow participants at 12-months post-treatment (total time = 18 months). Investigators will recruit children with overweight or obesity and two caregivers. Families will be assessed at 5 timepoints: baseline, mid-treatment, post-treatment, 6-month and 12-month follow-up. Assessments will include the following for the child and primary caregiver: anthropometry, blood sample collection, eating behaviors, and family relationship measures. The other caregiver will complete surveys about eating behaviors and family relationships. This program of research has the potential to advance the standard of practice for Latino children with overweight or obesity by developing tailored interventions which can be easily disseminated.

Conditions

• Childhood Obesity
• Minority Health

Interventions

Type	Name	Description
BEHAVIORAL	Parent-based treatment- All caregivers (PBT-AC)	PBT-AC provides all the elements of FBT, including nutrition and physical activity education, behavior therapy skills, and parenting skills.
BEHAVIORAL	Health Education (HE)	The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

Timeline

• Start date: 2022-09-08
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2022-06-29
• Last updated: 2025-04-01

Locations

1 site across 1 country: United States