StressNCT05676281
Healing Experiences of Adversity Among Latinos (HEALthy4You)
A study testing Healthy Together + Promotora Support, Healthy Together + Parenting Training and Healthy Togethers + Parenting Training + Promotora support in people with Stress and Childhood Obesity, run by University of California, San Diego at 2 sites in United States.
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"). Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Childhood Obesity
- What is being tested?
- Healthy Together + Promotora Support, Healthy Together + Parenting Training and Healthy Togethers + Parenting Training + Promotora support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Dec 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- Serious Developmental Disability (parent or child)
- Serious Mental Health Illness (parent or child)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Family Health Centers of San Diego
San Diego, California, 92104
Jessica Chapman
San Diego, California, 92124
About this study
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
- Being tested
- Healthy Together (Control), Healthy Together + Promotora Support, Healthy Together + Parenting Training, Healthy Togethers + Parenting Training + Promotora support
- 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
- Medical subject headings
- Pediatric Obesity, Obesity, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Together (Control)Behavioural
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 SupportBehavioural
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 TrainingBehavioural
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 supportBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy Together (includes Streetwyze) (Control/Standardized Care) | Other | 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. Receives: Behavioral: Healthy Together (Control) |
| Healthy Together + Promotora support | Active comparator | 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. Receives: Behavioral: Healthy Together + Promotora Support |
| Healthy Together + Parenting training | Active comparator | 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. Receives: Behavioral: Healthy Together + Parenting Training |
| Healthy Togethers + Parenting Training + Promotora support | Active comparator | 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. Receives: Behavioral: Healthy Togethers + Parenting Training + Promotora support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start20 Dec 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Family Health Centers of San Diego, UCSD Center for Community Health
- Responsible party
- Principal investigator, Eric Hekler, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676281
- Sponsor's protocol ID
- 802492
- Status last verified
- Mar 2025
- First submitted
- 22 Dec 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Experiences of Adversity Among Latinos (HEALthy4You)
- ClinicalTrials.gov ID
- NCT05676281
- Acronym / sponsor ID
- 802492
- Conditions
- Stress, Childhood Obesity
- Keywords
- ACEs, Obesity, Adverse Childhood Experiences, 2x2 Factorial Study, Behavioral Intervention, Health Education, Healthy Together, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Family Health Centers of San Diego, UCSD Center for Community Health
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Together (includes Streetwyze) (Control/Standardized Care) | Other | Behavioral: Healthy Together (Control)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. |
| Healthy Together + Promotora support | Active comparator | Behavioral: Healthy Together + Promotora SupportIn 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. |
| Healthy Together + Parenting training | Active comparator | Behavioral: Healthy Together + Parenting TrainingIn 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. |
| Healthy Togethers + Parenting Training + Promotora support | Active comparator | Behavioral: Healthy Togethers + Parenting Training + Promotora supportThose 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. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (2 listed)
- Serious Developmental Disability (parent or child)
- Serious Mental Health Illness (parent or child)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Healthy Together (includes Streetwyze) (Control/Standardized Care) |
| Healthy Together + Promotora SupportThe 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) | Behavioural | Healthy Together + Promotora support |
| Healthy Together + Parenting TrainingThe 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 | Behavioural | Healthy Together + Parenting training |
| Healthy Togethers + Parenting Training + Promotora supportThe 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 | Behavioural | Healthy Togethers + Parenting Training + Promotora support |
Primary outcome
Changes in Parents' Assessment of Protective Factors Self-Report Scale (comparison baseline to 6-months)
Time frame: 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)
1 secondary outcome
Changes to Child Body Mass Index (BMI) from baseline to 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Together + Promotora Support, Healthy Together + Parenting Training and Healthy Togethers + Parenting Training + Promotora support in people with Stress and Childhood Obesity, run by University of California, San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Parents' Assessment of Protective Factors Self-Report Scale (comparison baseline to 6-months) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.