Healing Experiences of Adversity Among Latinos (HEALthy4You)

NCT ID: NCT05676281

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-20
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Healthy Together (Control)

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Healthy Together + Promotora Support

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Healthy Together + Parenting Training

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Healthy Togethers + Parenting Training + Promotora support

Intervention Type: 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

Interventions

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

Intervention Type: 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)

Intervention Type: 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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Family Health Centers of San Diego

OTHER

Sponsor Role: collaborator

UCSD Center for Community Health

UNKNOWN

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Eric Hekler

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Family Health Centers of San Diego

San Diego, California, United States

Jessica Chapman

San Diego, California, United States

Countries

United States

Other Identifiers

802492

Identifier Type: -

Identifier Source: org_study_id