An interventional study of Healthy Together (Control) and Healthy Together + Promotora Support in Stress and Childhood Obesity, sponsored by University of California, San Diego. Completed at 2 sites in United States. Open to participants aged 5 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 240 is above the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Healthy Together (Control)
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.
Behavioral: Healthy Together + Promotora Support
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.
Behavioral: Healthy Together + Parenting Training
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.
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
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)
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
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
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)
Time frame: 6 months
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.
Time frame: 6 months
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of California, San Diego