Healing Experiences of Adversity Among Latinos (HEALthy4You)

Stress Clinical Trial

Official title:

Healing Experiences of Adversity Among Latinos (HEALthy4You)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05676281
• Other study ID #: 802492
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: February 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 1, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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)

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity
• Stress

Intervention

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
• 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)
• 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
• 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

Locations

Country	Name	City	State
United States	Family Health Centers of San Diego	San Diego	California
United States	Jessica Chapman	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	Family Health Centers of San Diego, UCSD Center for Community Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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