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

Primary Purpose

Childhood Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Families OverComing Under Stress Trauma Informed Care in Childhood Obesity among Minorities (FOCUS TIC-COM)
Sponsored by
Charles Drew University of Medicine and Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Childhood Obesity focused on measuring trauma informed care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    FOCUS TIC-COM arm

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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".
    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".
    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".
    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.

    Secondary Outcome Measures

    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).
    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.

    Full Information

    First Posted
    July 8, 2021
    Last Updated
    September 23, 2022
    Sponsor
    Charles Drew University of Medicine and Science
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04980001
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2022 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    July 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Charles Drew University of Medicine and Science

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Childhood Obesity
    Keywords
    trauma informed care

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    280 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    FOCUS TIC-COM arm
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Families OverComing Under Stress Trauma Informed Care in Childhood Obesity among Minorities (FOCUS TIC-COM)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    RAND/UCLA Appropriateness Method - Expert Panel Ratings / Consensus
    Description
    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.
    Time Frame
    Four rounds of rating over the course of 6 month to 1 year (Year 1 of study)
    Title
    FOCUS TIC-COM Training Evaluation - Provider's Perceived confidence
    Description
    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".
    Time Frame
    Baseline and immediately after training (Year 2 of study)
    Title
    Health care provider satisfaction of FOCUS TIC-COM
    Description
    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".
    Time Frame
    Last 6 months of Year 2 of study
    Title
    Parent / Caregiver satisfaction of FOCUS TIC-COM
    Description
    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".
    Time Frame
    Last 6 months of Year 2 of study
    Title
    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
    Description
    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.
    Time Frame
    Last 6 months of Year 2 of study
    Secondary Outcome Measure Information:
    Title
    Calculated child BMI per parent / caregiver report
    Description
    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).
    Time Frame
    Last 6 months of Year 2 of study
    Title
    Parent-reported linkages to behavioral health services
    Description
    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.
    Time Frame
    Last 6 months of Year 2 of study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Angela L Venegas-Murillo, MD MPH MS
    Phone
    3233872520
    Email
    angelavenegas@cdrewu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shervin Assari, MD MPH
    Phone
    7343632678
    Email
    shervinassari@cdrewu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Angela L Venegas-Murillo, MD MPH MS
    Organizational Affiliation
    Charles Drew University of Medicine and Science
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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