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

Childhood Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04980001
• Other study ID #: 1766233-1
• Status: Withdrawn
• Phase: N/A
• Start date: June 2024
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: Charles Drew University of Medicine and Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Year 1:

Inclusion Criteria:

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

Exclusion Criteria:

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

Year 2:

Inclusion Criteria:

• 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:

• 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

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charles Drew University of Medicine and Science

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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	Calculated child BMI per parent / caregiver report	The investigators plan to collect parent / caregiver reported height (in meters squared) and weight (kilograms) of their child who received the FOCUS TIC-COM intervention. The height and weight of the child will be aggregated to calculate the child's body mass index (BMI).	Last 6 months of Year 2 of study
Secondary	Parent-reported linkages to behavioral health services	The investigators will ask parents / caregivers if their child who is overweight / obese was referred to behavioral health services by their health care provider. The investigators will also ask if those services were obtained or not.	Last 6 months of Year 2 of study