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Healing Experiences of Adversity Among Latinos (HEALthy4You)

Healing Experiences of Adversity Among Latinos (HEALthy4You)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05676281
Enrollment
240
Registered
2023-01-09
Start date
2022-12-20
Completion date
2024-12-31
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity, Stress

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

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.

Interventions

BEHAVIORALHealthy 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

BEHAVIORALHealthy 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)

BEHAVIORALHealthy 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

BEHAVIORALHealthy 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

Sponsors

Family Health Centers of San Diego
CollaboratorOTHER
UCSD Center for Community Health
CollaboratorUNKNOWN
University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Changes in Parents' Assessment of Protective Factors Self-Report Scale (comparison baseline to 6-months)6 monthsParents' 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

MeasureTime frameDescription
Changes to Child Body Mass Index (BMI) from baseline to 6 months6 monthsWeight and height will be combined to report BMI in kg/m\^2.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026