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Healthy Together Program for Childhood Obesity and Stress

N/A

Recruiting

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will study how to reduce the effects of difficult childhood experiences on Latino familes and how to treat childhood obesity.

Who is the study for?

The HEALthy4You trial is for Latino families with children aged 5-11 who are overweight (BMI ≥ 85th percentile) and at risk for adverse childhood experiences. Parents or guardians, including non-biological ones, must be willing to participate in a 6-month program and speak English or Spanish. They should already be patients at Family Health Centers of San Diego. Families with serious developmental disabilities or mental health illnesses are excluded.Check my eligibility

What is being tested?

This study tests four approaches to reduce stress and childhood obesity among Latinos: 'Healthy Together' as the control group; 'Healthy Together + Parenting Training'; adding Promotora support to each; assessing which combination best influences family protective factors against systemic/family stressors related to adverse child events.See study design

What are the potential side effects?

Since this trial involves lifestyle interventions like parenting training and community support rather than medication, typical medical side effects aren't expected. However, participants may experience changes in family dynamics or emotional responses due to new routines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Parents' Assessment of Protective Factors Self-Report Scale (comparison baseline to 6-months)

Secondary outcome measures

Changes to Child Body Mass Index (BMI) from baseline to 6 months

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Healthy Together (includes Streetwyze) (Control/Standardized Care)Experimental Treatment1 Intervention

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.

Group II: Healthy Together + Promotora supportActive Control1 Intervention

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.

Group III: Healthy Togethers + Parenting Training + Promotora supportActive Control1 Intervention

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.

Group IV: Healthy Together + Parenting trainingActive Control1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,120 Previous Clinical Trials

1,521,207 Total Patients Enrolled

Family Health Centers of San DiegoOTHER

6 Previous Clinical Trials

14,373 Total Patients Enrolled

UCSD Center for Community HealthUNKNOWN

Media Library

Healthy Together + Parenting Training Clinical Trial Eligibility Overview. Trial Name: NCT05676281 — N/A

Childhood Obesity Research Study Groups: Healthy Together + Promotora support, Healthy Togethers + Parenting Training + Promotora support, Healthy Together (includes Streetwyze) (Control/Standardized Care), Healthy Together + Parenting training

Childhood Obesity Clinical Trial 2023: Healthy Together + Parenting Training Highlights & Side Effects. Trial Name: NCT05676281 — N/A

Healthy Together + Parenting Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05676281 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial available to individuals over the age of 45?

"This clinical trial is only open to applicants between the ages of 5 and 11. There are 167 studies for minors, as well as 125 that focus on individuals over 65 years old."

Answered by AI

Are enrollment slots still open for this trial?

"Affirmative. Clinicaltrials.gov supports that this clinical trial is presently accepting patients, having initially been posted on December 20th 2022 and last edited on January 11th 2023. This study requires 200 participants to be enrolled between 2 different locations."

Answered by AI

What is the maximum participant capacity for this research endeavor?

"Affirmative. The information on clinicaltrials.gov suggests this medical trial is still accepting applicants, having been initially posted on December 20th 2022 and recently updated on January 11th 2023. This study requires 200 volunteers to be recruited from two respective sites."

Answered by AI

Am I eligible to partake in this clinical experiment?

"This clinical trial is searching for 200 minors between five and eleven years old who suffer from pediatric obesity. To qualify, children must be clients of Family Health Centers of San Diego with a BMI in the 85th to 99.9th percentile range as determined by their provider; moreover, parents or guardians (including non-biological relatives) aged 18+ that speak either English or Spanish need to join them in this endeavour."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Healing Experiences of Adversity Among Latinos (HEALthy4You)

Eric Hekler 2022. "Healing Experiences of Adversity Among Latinos (HEALthy4You)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05676281.