Healing Experiences of Adversity Among Latinos (HEALthy4You)

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.

Study Overview

• Status: Recruiting
• Conditions: Stress; Childhood Obesity
• Intervention / Treatment: Behavioral: Healthy Together (Control); Behavioral: Healthy Together + Promotora Support; Behavioral: Healthy Together + Parenting Training; Behavioral: Healthy Togethers + Parenting Training + Promotora support

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92104
      • Recruiting
      • Family Health Centers of San Diego
      • Contact: Job Godino, PhD; Phone Number: 619-515-2520; Email: H4Y@health.ucsd.edu
      • Contact: Eric Hekler; Phone Number: (858) 534-1251; Email: H4Y@health.ucsd.edu
    • San Diego, California, United States, 92124
      • Recruiting
      • Jessica Chapman
      • Contact: Jessica Chapman; Phone Number: 858-534-1251; Email: H4Y@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy Together (includes Streetwyze) (Control/Standardized Care); 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.	Behavioral: Healthy Together (Control); The total number of sessions families will engage with will be negotiated between the Families and their Care providers. This allows for families to receive care while still honoring their constraints, such as the amount of time they can dedicate per week and over the course of the study, to the intervention. The maximum number of possible sessions include: 6 Sessions with a Wellness Coach; 4-8 sessions with a Dietician; 4-8 sessions of Physical Theraphy; 1 session during month 1 or 2 Streetwyze Training; Safety Net Referrals
Active Comparator: 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.	Behavioral: Healthy Together + Promotora Support; The total number of sessions families will engage with will be negotiated between the Families and their Care providers. This allows for families to receive care while still honoring their constraints, such as the amount of time they can dedicate per week and over the course of the study, to the intervention. The maximum number of possible sessions include: 6 Sessions with a Wellness Coach; 4-8 sessions with a Dietician; 4-8 sessions of Physical Theraphy; 1 session during month 1 or 2 Streetwyze Training; Safety Net Referrals; 16-20 Promotora (in home case management) Sessions (weekly first 2 months, afterwards at least bi-weekly)
Active Comparator: 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.	Behavioral: Healthy Together + Parenting Training; The total number of sessions families will engage with will be negotiated between the Families and their Care providers. This allows for families to receive care while still honoring their constraints, such as the amount of time they can dedicate per week and over the course of the study, to the intervention. The maximum number of possible sessions include: 6 Sessions with a Wellness Coach; 4-8 sessions with a Dietician; 4-8 sessions of Physical Theraphy; 1 session during month 1 or 2 Streetwyze Training; Safety Net Referrals; 6-10 Parenting Sessions with a Family Health Centers Mental Health Provider using the Incredible Years Curriculum
Active Comparator: 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.	Behavioral: Healthy Togethers + Parenting Training + Promotora support; The total number of sessions families will engage with will be negotiated between the Families and their Care providers. This allows for families to receive care while still honoring their constraints, such as the amount of time they can dedicate per week and over the course of the study, to the intervention. The maximum number of possible sessions include: 6 Sessions with a Wellness Coach; 4-8 sessions with a Dietician; 4-8 sessions of Physical Theraphy; 1 session during month 1 or 2 Streetwyze Training; Safety Net Referrals; 16-20 Promotora (in home case management) Sessions (weekly first 2 months, afterwards at least bi-weekly); 8-10 Parenting Sessions with a Family Health Centers Mental Health Provider using the Incredible Years Curriculum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Parents' Assessment of Protective Factors Self-Report Scale (comparison baseline to 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)	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Family Health Centers of San Diego; UCSD Center for Community Health

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Pediatric; Health Education; Behavioral Intervention; Parenting; Precision Medicine; Hispanic; Protective Factors; Latino; Federally Qualified Health Centers; Adverse Childhood Experiences; ACEs; 2x2 Factorial Study; Healthy Together; Whole Child Wellness
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 802492

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No