Childhood ObesityNCT04980001
Trauma Informed Childhood Obesity Care for Low-Income Minorities in Primary Care
A study testing Families OverComing Under Stress Trauma Informed Care in Childhood Obesity among Minorities (FOCUS TIC-COM) in people with Childhood Obesity, run by Charles Drew University of Medicine and Science.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Families OverComing Under Stress Trauma Informed Care in Childhood Obesity among Minorities (FOCUS TIC-COM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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
- Being tested
- Families OverComing Under Stress Trauma Informed Care in Childhood Obesity among Minorities (FOCUS TIC-COM)
- Keywords
- trauma informed care
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Families OverComing Under Stress Trauma Informed Care in Childhood Obesity among Minorities (FOCUS TIC-COM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Families OverComing Under Stress Trauma Informed Care in Childhood Obesity among Minorities (FOCUS TIC-COM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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.
Measured: Last 6 months of Year 2 of study
Secondary outcomes (2)
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).
Measured: Last 6 months of Year 2 of study
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.
Measured: Last 6 months of Year 2 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study startJun 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJul 2025 (estimated)
Why it stopped: The study was not started due to several factors: partial IRB approval; limited community partner engagement; and grant funding support expired.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Venegas, Charles Drew University of Medicine and Science
- Investigators
- Angela L Venegas-Murillo, MD MPH MS, Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980001
- Sponsor's protocol ID
- 1766233-1
- Status last verified
- Feb 2024
- First submitted
- 8 Jul 2021
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma Informed Childhood Obesity Care for Low-Income Minorities in Primary Care
- ClinicalTrials.gov ID
- NCT04980001
- Acronym / sponsor ID
- 1766233-1
- Conditions
- Childhood Obesity
- Keywords
- trauma informed care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not started due to several factors: partial IRB approval; limited community partner engagement; and grant funding support expired.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| FOCUS TIC-COM arm | Experimental | Behavioral: Families OverComing Under Stress Trauma Informed Care in Childhood Obesity among Minorities (FOCUS TIC-COM)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Individuals outside of the fields of trauma informed care or childhood obesity
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | FOCUS TIC-COM arm |
Primary outcome
RAND/UCLA Appropriateness Method - Expert Panel Ratings / Consensus
Time frame: Four rounds of rating over the course of 6 month to 1 year (Year 1 of study)
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
Time frame: Baseline and immediately after training (Year 2 of study)
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
Time frame: Last 6 months of Year 2 of study
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
Time frame: Last 6 months of Year 2 of study
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
Time frame: Last 6 months of Year 2 of study
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.
2 secondary outcomes
Calculated child BMI per parent / caregiver report
Time frame: Last 6 months of Year 2 of study
Parent-reported linkages to behavioral health services
Time frame: Last 6 months of Year 2 of study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela L Venegas-Murillo, MD MPH MS principal investigator
Charles Drew University of Medicine and Science
Questions about this trial
What is this clinical trial studying?
A study testing Families OverComing Under Stress Trauma Informed Care in Childhood Obesity among Minorities (FOCUS TIC-COM) in people with Childhood Obesity, run by Charles Drew University of Medicine and Science.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RAND/UCLA Appropriateness Method - Expert Panel Ratings / Consensus (time frame: Four rounds of rating over the course of 6 month to 1 year (Year 1 of study)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.