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Healing Experiences of Adversity Among Latinos (HEALthy4You)

Primary Purpose

Stress, Childhood Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Together (Control)
Healthy Together + Promotora Support
Healthy Together + Parenting Training
Healthy Togethers + Parenting Training + Promotora support
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring ACEs, Obesity, Adverse Childhood Experiences, 2x2 Factorial Study, Behavioral Intervention, Health Education, Healthy Together, Parenting, Protective Factors, Precision Medicine, Federally Qualified Health Centers, Latino, Hispanic, Pediatric, Whole Child Wellness

Eligibility Criteria

5 Years - 11 Years (Child)All SexesAccepts 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)

Sites / Locations

  • Family Health Centers of San DiegoRecruiting
  • Jessica ChapmanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Active Comparator

Active Comparator

Active Comparator

Arm Label

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

Healthy Together + Promotora support

Healthy Together + Parenting training

Healthy Togethers + Parenting Training + Promotora support

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
December 22, 2022
Last Updated
January 11, 2023
Sponsor
University of California, San Diego
Collaborators
Family Health Centers of San Diego, UCSD Center for Community Health
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1. Study Identification

Unique Protocol Identification Number
NCT05676281
Brief Title
Healing Experiences of Adversity Among Latinos (HEALthy4You)
Official Title
Healing Experiences of Adversity Among Latinos (HEALthy4You)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Family Health Centers of San Diego, UCSD Center for Community Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Childhood Obesity
Keywords
ACEs, Obesity, Adverse Childhood Experiences, 2x2 Factorial Study, Behavioral Intervention, Health Education, Healthy Together, Parenting, Protective Factors, Precision Medicine, Federally Qualified Health Centers, Latino, Hispanic, Pediatric, Whole Child Wellness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Together (includes Streetwyze) (Control/Standardized Care)
Arm Type
Other
Arm 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.
Arm Title
Healthy Together + Promotora support
Arm Type
Active Comparator
Arm 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.
Arm Title
Healthy Together + Parenting training
Arm Type
Active Comparator
Arm 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.
Arm Title
Healthy Togethers + Parenting Training + Promotora support
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Together (Control)
Intervention Description
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
Intervention Name(s)
Healthy Together + Promotora Support
Intervention Description
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
Intervention Name(s)
Healthy Together + Parenting Training
Intervention Description
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
Intervention Name(s)
Healthy Togethers + Parenting Training + Promotora support
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in Parents' Assessment of Protective Factors Self-Report Scale (comparison baseline to 6-months)
Description
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
Secondary Outcome Measure Information:
Title
Changes to Child Body Mass Index (BMI) from baseline to 6 months
Description
Weight and height will be combined to report BMI in kg/m^2.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Family Health Centers of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Job Godino, PhD
Phone
619-515-2520
Email
H4Y@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Eric Hekler
Phone
(858) 534-1251
Email
H4Y@health.ucsd.edu
Facility Name
Jessica Chapman
City
San Diego
State/Province
California
ZIP/Postal Code
92124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Chapman
Phone
858-534-1251
Email
H4Y@health.ucsd.edu

12. IPD Sharing Statement

Learn more about this trial

Healing Experiences of Adversity Among Latinos (HEALthy4You)

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