Healing Experiences of Adversity Among Latinos (HEALthy4You)

University of California San Diego

Status: Completed

Conditions: Childhood Obesity; Stress

Treatments: Behavioral: Healthy Together + Promotora Support; Behavioral: Healthy Togethers + Parenting Training + Promotora support; Behavioral: Healthy Together (Control); Behavioral: Healthy Together + Parenting Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05676281

802492

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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240 participants in 4 patient groups

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

Other group

Description:

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.

Treatment:

Behavioral: Healthy Together (Control)

Healthy Together + Promotora support

Active Comparator group

Description:

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.

Treatment:

Behavioral: Healthy Together + Promotora Support

Healthy Together + Parenting training

Active Comparator group

Description:

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.

Treatment:

Behavioral: Healthy Together + Parenting Training

Healthy Togethers + Parenting Training + Promotora support

Active Comparator group

Description:

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.

Treatment:

Behavioral: Healthy Togethers + Parenting Training + Promotora support