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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05676281
Other study ID # 802492
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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