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Completed

NCT Number: NCT05676281

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.

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Key information

Conditions

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

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Family Health Centers of San Diego, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 + 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 + 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 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

Primary outcomes

  1. Changes in Parents' Assessment of Protective Factors Self-Report Scale (comparison baseline to 6-months)

    Time frame: 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 outcomes

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

    Time frame: 6 months

    Weight and height will be combined to report BMI in kg/m^2.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Family Health Centers of San Diego
  • UCSD Center for Community Health

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2023
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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