Healing Experiences of Adversity Among Latinos (HEALthy4You)

NCT05676281 | Completed

• 1 other identifier: 802492
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

Stress; Childhood Obesity

Keywords

ACEs; Obesity; Adverse Childhood Experiences; 2x2 Factorial Study; Behavioral Intervention; Health Education; Healthy Together; Parenting; Protective Factors; Precision Medicine; Federally Qualified Health Centers; Latino; Hispanic; Pediatric; Whole Child Wellness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes to Child Body Mass Index (BMI) from baseline to 6 months

  6 months

Study Arms (4)

Healthy Together (includes Streetwyze) (Control/Standardized Care)

OTHER

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)

Healthy Together + Promotora support

ACTIVE COMPARATOR

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

Healthy Together + Parenting training

ACTIVE COMPARATOR

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

Healthy Togethers + Parenting Training + Promotora support

ACTIVE COMPARATOR

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

Interventions

Healthy Together (Control) BEHAVIORAL

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

Healthy Together (includes Streetwyze) (Control/Standardized Care)

Healthy Together + Promotora Support BEHAVIORAL

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)

Healthy Together + Promotora support

Healthy Together + Parenting Training BEHAVIORAL

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

Healthy Together + Parenting training

Healthy Togethers + Parenting Training + Promotora support BEHAVIORAL

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

Healthy Togethers + Parenting Training + Promotora support

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• years or older
• English or Spanish speaking
• Willingness to commit to 6 months of the program

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead
• Family Health Centers of San Diego: collaborator
• UCSD Center for Community Health: collaborator

Study Sites (2)

Family Health Centers of San Diego

San Diego, California, 92104, United States

Location

Jessica Chapman

San Diego, California, 92124, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Obesity; Health Education

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 9, 2023
• Study Start: December 20, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

US (2)