Trauma Informed Childhood Obesity Care for Low-Income Minorities in Primary Care

NCT ID: NCT04980001

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-07-31

Brief Summary

The purpose of this pilot study is to examine changes in childhood obesity associated with the implementation of a Trauma Informed Care approach with weight counseling and management among low-income minority children in a primary care setting.

Detailed Description

Prospective mixed methods pilot study, using both qualitative and quantitative measures. This study will be conducted in two phases. In Phase 1 (Year 1), the investigators plan to use a modified Delphi procedure called the RAND/UCLA Appropriateness Method in which the investigators will form a multidisciplinary panel to develop a consensus of incorporating the TIC practices based on FOCUS into current best practices for childhood obesity prevention and treatment among low-income minorities to be facilitated by primary care providers. In Phase 2 (Year 2), the investigators will train and implement the Primary Care Provider-mediated FOCUS TIC-COM among providers for obese children and their caregivers / parents in the MLK OPC Family Medicine Clinic. During this phase, the investigators plan to examine the feasibility and acceptability of delivering the FOCUS TIC-COM in the primary care setting at MLKOPC through surveys and focus groups with both providers and the parents / caregivers of overweight / obese children. The investigators will also explore whether the FOCUS TIC-COM impact on childhood obesity (as perceived by child's parent / caregiver) and increase linkages to behavioral health care regarding trauma / toxic stress. At 3 month intervals, the investigators will train a subset of providers in the intervention and they will implement the intervention immediately after training.

Conditions

Childhood Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

FOCUS TIC-COM arm

Health care providers will be trained in FOCUS TIC-COM through professional development and from this group the investigators plan to recruit participants for the surveys about the training, intervention feasibility and acceptability. Health care providers will be encouraged to implement FOCUS TIC-COM will all of their pediatric patients who are overweight/obese.

Parents / Caregivers of children who are overweight or obese will be recruited into the study after exposure to the intervention. Only those exposed to the intervention will be recruited to participate in the study which includes one survey and focus groups.

Group Type: EXPERIMENTAL

Families OverComing Under Stress Trauma Informed Care in Childhood Obesity among Minorities (FOCUS TIC-COM)

Intervention Type: BEHAVIORAL

FOCUS TIC-COM is a program that helps doctors coach families to recognize how emotions or feelings about various life stressors may affect a child's dietary choices and physical activity. FOCUS TIC-COM is for families of children who have been identified by their doctor as overweight or obese. The goal of the program is to help children and their families understand how their mental health may impact their physical health and develop strategies to address their mental health needs.

Interventions

Families OverComing Under Stress Trauma Informed Care in Childhood Obesity among Minorities (FOCUS TIC-COM)

FOCUS TIC-COM is a program that helps doctors coach families to recognize how emotions or feelings about various life stressors may affect a child's dietary choices and physical activity. FOCUS TIC-COM is for families of children who have been identified by their doctor as overweight or obese. The goal of the program is to help children and their families understand how their mental health may impact their physical health and develop strategies to address their mental health needs.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adult Experts (>18 years old) in the fields of trauma informed care and childhood obesity among low-income minorities

• Parents / Caregivers of overweight/obese children (ages 2-17 years old) in MLK-OPC who speak English or Spanish
• Primary Care Providers (>18 years old) who work in the Family Medicine Clinic of the MLK-OPC

Exclusion Criteria

• Individuals outside of the fields of trauma informed care or childhood obesity

Year 2:

• Parents / Caregivers of children that are not overweight/obese and/or under 2 years old
• Parent or caregiver that speaks a language other than English or Spanish
• Primary Care Providers who do not work in the Family Medicine Clinic of the MLK-OPC

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Charles Drew University of Medicine and Science

OTHER

Sponsor Role: lead

Responsible Party

Angela Venegas

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela L Venegas-Murillo, MD MPH MS

Role: PRINCIPAL_INVESTIGATOR

Charles Drew University of Medicine and Science

Other Identifiers

1766233-1

Identifier Type: -

Identifier Source: org_study_id