Healing Experiences of Adversity Among Latinos (HEALthy4You)

Not Applicable

Completed

• Conditions: Stress; Childhood Obesity
• Interventions: Behavioral: Healthy Together (Control); Behavioral: Healthy Together + Promotora Support; Behavioral: Healthy Together + Parenting Training; Behavioral: Healthy Togethers + Parenting Training + Promotora support

• Registration Number: NCT05676281
• Lead Sponsor: University of California, San Diego

Brief Summary

Healing Experiences of Adversity Among Latinos (HEALthy4You) is a project funded by the California Initiative for the Advancement of Precision Medicine ("Advancing a Precision Population Health Approach to ACEs to Reduce Health Disparities"). The long-term goal of this project is to develop community-centered, culturally Appropriate, precision Interventions that can be delivered within Federally Qualified Healthcare Centers (FQHCs) for Latino Families, to reduce Adverse Child Events (ACES) risks and treat childhood obesity. UCSD in conjunction with Family Health Centers of San Diego (FHCSD) will conduct a 2x2 factorial trial with four groups meant to determine what combination of intervention components influence family protective factors (a key marker for reduced risk of the deleterious effects of systemic and family/individual stressors that are a critical part of ACEs) and childhood obesity.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-20
• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2023-01-09
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Child
• Currently a patient at Family Health Centers of San Diego
• Age 5-11 years old
• BMI ≥ 85th percentile to 99.9th percentile
• Social determination or risk for ACE determined as being a patient receiving care at an FQHC (confirmed via provider)
• Parent
• Parent or guardian (including non-biological parent or relative) willing to participate
• Self-identification as Hispanic or Latino
• 18 years or older
• English or Spanish speaking
• Willingness to commit to 6 months of the program

Exclusion Criteria

• Serious Developmental Disability (parent or child)
• Serious Mental Health Illness (parent or child)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Healthy Together (includes Streetwyze) (Control/Standardized Care)	Healthy Together (Control)	Control - standardized Healthy Together program: The Healthy Together Program is not standard of care at Family Health Centers (FHC). Instead, it was originally developed by FHC clinicians interested in addressing childhood obesity and has been implemented by a limited number of clinicians at FHC. UCSD has been working in partnership with FHC to create standardized protocols and to incorporate additional research-oriented tools into this standardized protocol, which will be used as our experimental control.
Healthy Together + Promotora support	Healthy Together + Promotora Support	In addition to the basic program described above, those randomized to this intervention will receive Promotora support. Families assigned to a promotora will receive 30-60 minutes of phone-based support weekly, with more frequent interactions that will taper starting at month 3 of the intervention. Promotoras may also provide home-visit support up to 4 times during the 6 months, based on family interest and needs. The wellness coach will try to minimize in-person meetings with FHC professionals each week and space out visits to reduce burden on families. For families in this condition, they will be asked to engage in at least 30 minutes of additional sessions per week with the promotora beyond the 1- hour allotted time working with FHC professionals.
Healthy Together + Parenting training	Healthy Together + Parenting Training	In addition to the basic program described above, those randomized to this intervention will attend Parenting Training sessions with the mental health provider at FHC. Families assigned to parenting training will receive 10-12 sessions. Sessions will focus on topics like strategies to support the child's physical, social, and emotional growth. The wellness coach will try to minimize in-person meetings with FHC professionals each week and space out visits to reduce burden on families.
Healthy Togethers + Parenting Training + Promotora support	Healthy Togethers + Parenting Training + Promotora support	Those randomized to this intervention will receive all components described above including the Healthy Together Program, Parenting Training and Promotora support. The wellness coach will try to minimize in-person meetings with FHC professionals each week and space out visits to reduce burden on families.. Families in this group will also be asked to engage in at least 30-60 minutes of additional sessions per week including up to 4 home visits.

Primary Outcome Measures

Name	Time	Method
Changes in Parents' Assessment of Protective Factors Self-Report Scale (comparison baseline to 6-months)	6 months	Parents' Assessment of Protective Factors (PAPF) Instrument consists of 36 items to measure the presence, strength, and growth of parents' self-reported beliefs, feelings, and behaviors that are regarded as indicators of the Strengthening Families protective factors using a 5-point response system from "Not at all like me" to "Very much like me" (Score scale: 0 Low - 3.99 High)

Secondary Outcome Measures

Name	Time	Method
Changes to Child Body Mass Index (BMI) from baseline to 6 months	6 months	Weight and height will be combined to report BMI in kg/m\^2.

Trial Locations

Locations (2)

Family Health Centers of San Diego; 🇺🇸 San Diego, California, United States

Jessica Chapman; 🇺🇸 San Diego, California, United States