Clinical trial NCT04980001: Trauma Informed Childhood Obesity Care for Low-Income Minorities in Primary Care
Official title: Trauma Informed Childhood Obesity Care for Low-Income Minorities in Primary Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Childhood Obesity
Keywords: trauma informed care
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: RAND/UCLA Appropriateness Method - Expert Panel Ratings / Consensus
timeFrame: Four rounds of rating over the course of 6 month to 1 year (Year 1 of study)
measure: FOCUS TIC-COM Training Evaluation - Provider's Perceived confidence
timeFrame: Baseline and immediately after training (Year 2 of study)
measure: Health care provider satisfaction of FOCUS TIC-COM
timeFrame: Last 6 months of Year 2 of study
measure: Parent / Caregiver satisfaction of FOCUS TIC-COM
timeFrame: Last 6 months of Year 2 of study
measure: 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
timeFrame: Last 6 months of Year 2 of study
Secondary outcomes:
measure: Calculated child BMI per parent / caregiver report
timeFrame: Last 6 months of Year 2 of study
measure: Parent-reported linkages to behavioral health services
timeFrame: Last 6 months of Year 2 of study
Other outcomes:
Locations:
Study officials:
affiliation: Charles Drew University of Medicine and Science
name: Angela L Venegas-Murillo, MD MPH MS
role: PRINCIPAL_INVESTIGATOR
References: