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

NCT04980001 | Withdrawn DMC

• 1 other identifier: 1766233-1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Childhood Obesity

Keywords

trauma informed care

Outcome Measures

Primary Outcomes (5)

• RAND/UCLA Appropriateness Method - Expert Panel Ratings / Consensus

  The investigators plan to use a modified Delphi procedure called the RAND/UCLA Appropriateness Method to reach consensus regarding the content and implementation of a Primary Care Provider-mediated FOCUS TIC-COM approach to address childhood obesity in low-income minority communities. The RAND/UCLA Appropriateness Method consists of four rounds of rating clinical indicators or practice guidelines derived from current literature on TIC that will be incorporated into the current standard of childhood obesity prevention and management. A benefit-to-cost ratio will be rated on a 9 point Likert scale, where 1 means that the expected harms greatly outweigh the expected benefits in relation to cost, and 9 means that the expected benefits greatly outweigh the expected harms in relation to cost. Necessity rating scale will be on a Likert scale of 1 to 9, where 1 means that the practice guideline is not necessary at all, and 9 means that the practice guideline is extremely necessary.

  Four rounds of rating over the course of 6 month to 1 year (Year 1 of study)

• FOCUS TIC-COM Training Evaluation - Provider's Perceived confidence

  The investigators plan to conduct a pre/post training evaluation measuring perceived confidence in FOCUS TIC-COM approach for overweight/obese children. The investigators will use a 5 point likert scale to measure confidence level in FOCUS TIC-COM approach, where 1 means "not confident at all" and 5 means "very confident". The 5 point likert scale for confidence has the following values: 1 means "not confident at all"; 2 means "not very confident"; 3 means "somewhat confident"; 4 means "fairly confident"; and 5 means "very confident".

  Baseline and immediately after training (Year 2 of study)

• Health care provider satisfaction of FOCUS TIC-COM

  The investigators plan to collect health care provider satisfaction in delivering the FOCUS TIC-COM. The investigators will measure satisfaction of various elements of the intervention using a 5 point Satisfaction Likert scale, where 1 means "very unsatisfied" and 5 means "very satisfied".

  Last 6 months of Year 2 of study

• Parent / Caregiver satisfaction of FOCUS TIC-COM

  The investigators plan to collect parent / caregiver satisfaction in receiving the FOCUS TIC-COM intervention. The investigators will measure satisfaction of various elements of the intervention using a 5 point Satisfaction Likert scale, where 1 means "very unsatisfied" and 5 means "very satisfied".

  Last 6 months of Year 2 of study

• Feasibility and acceptability of delivering FOCUS TIC-COM in the primary care setting, as perceived by caregivers/parents of low-income minority obese children and their providers

  The investigators will conduct focus groups with both health care providers and parents/caregivers of overweight/obese children exposed to FOCUS TIC-COM to assess intervention feasibility and acceptability. The investigators will ask questions in the focus group discussion on whether the Primary Care Provider-mediated FOCUS TIC-COM is relevant, appropriate and sustainable for the primary care setting and if the intervention should be disseminated. In addition, the investigators will examine the demand, practicality, adaptation, integration, expansion and efficacy of the intervention through the focus group discussion. The focus group questions will be derived from the RE-AIM framework: Reach into the target population; Effectiveness / Efficacy; Adaptation by target settings, institutions, and staff; Implementation - consistency and cost of delivery; Maintenance of intervention effects.

  Last 6 months of Year 2 of study

Secondary Outcomes (2)

• Calculated child BMI per parent / caregiver report

  Last 6 months of Year 2 of study

• Parent-reported linkages to behavioral health services

  Last 6 months of Year 2 of study

Study Arms (1)

FOCUS TIC-COM arm

EXPERIMENTAL

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.

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

Interventions

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

FOCUS TIC-COM arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Individuals outside of the fields of trauma informed care or childhood obesity
• Year 2:
• 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
• 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

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Angela L Venegas-Murillo, MD MPH MS

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants will have access to the FOCUS TIC-COM intervention. The health care providers at the family medicine clinic within MLK-OPC will be trained to implement FOCUS TIC-COM with children who are overweight or obese. The investigators plan to survey and perform focus groups with health care providers and the parents / caregivers of children who were identified as overweight or obese by their doctor.

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 28, 2021
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share