Child ObesityNCT06520657
Addressing Social Determinants of Health in Child Obesity Treatment Using Community Health Workers
A study testing Community Health Worker and Child weight management intervention in people with Child Obesity and Social Determinants of Health, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The goal of this small pilot study is to test the feasibility of combining a three-month intervention of working with a community health worker (CHW) to address social risk factors for patients prior to beginning a group weight management program for childhood obesity -- Promoting Health in Teens and Kids (PHIT Kids) Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Child Obesity, Social Determinants of Health
- What is being tested?
- Community Health Worker and Child weight management intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Family must have one major social risk factor on the Protocol for Responding to \& Assessing Patients' Assets, Risks \& Experiences (PRAPARE) of the 14 modifiable risk factors
- Child aged 8 through 12 years of age
- Child with BMI% at 85th percentile or higher and less than the 120% of the 95th percentile (overweight or class 1 obesity)
- Child must live with parent/guardian at least 5 out of the 7 days on average (70% of the time)
- Child and parent able to speak English
Who cannot join
- Child on medications known to cause ongoing weight gain (e.g., atypical anti-psychotics, chronic prednisone, insulin)
- Child on other medications know to affect weight if dose and BMI z-score has not been stable for 3 months.
- Diabetes or other disease that has a significant effect on diet, physical activity, or ability to take part in trial activities besides obesity (does not included treated or mild depression or anxiety, limited food allergies or mild physical activity limitations)
- For parents: new MI, stroke or cancer diagnosis (excluding localized skin cancers) in past 6 months, history of bariatric surgery within the past 3 years, pregnancy in last 6 months or planned within 1 year
- Child or parent has significant developmental or cognitive impairments or other significant medical issue that would interfere with ability to participate or complete assessment
- Parent or child has significant physical limitation
- Parent/child planning to move to from Children's Mercy Kansas City (CMKC) service area
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Kansas City
Kansas City, Missouri, 64108
About this study
Official title: Addressing Social Determinants of Health in Child Obesity Treatment Using Community Health Workers: the Role of Parental Bandwidth in Treatment Effectiveness
The goal of this small pilot study is to test the feasibility of combining a three-month intervention of working with a community health worker (CHW) to address social risk factors for patients prior to beginning a group weight management program for childhood obesity -- Promoting Health in Teens and Kids (PHIT Kids)
- Conditions
- Child Obesity, Social Determinants of Health
- Being tested
- Community Health Worker, Child weight management intervention, Standard of Care referral to resources
- Keywords
- Community Health Workers, Randomized trial, Pilot Study, Child Obesity Treatment, Executive function
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health WorkerOther
Participants are screened for social determinants of health and work with a community health worker for three months to connect them with community and government services to address their family's needs.
Child weight management interventionBehavioural
This is a 12-week family-based behavioral group intervention to address childhood overweight and obesity.
Standard of Care referral to resourcesOther
One-time referral to resources based on need that families can access independently either by providing electronic referral to or providing written contact information for a community resource.
| Study group | Role | What they receive |
|---|---|---|
| CHW plus child weight management intervention | Experimental | Participants in this arm will work with a community health worker for three months to address social risk factors (negative social determinants of health) prior to beginning a child weight management group treatment. Receives: Other: Community Health Worker; Behavioral: Child weight management intervention; Other: Standard of Care referral to resources |
| Child weight management intervention only | Active comparator | Participants in this arm will receive the standard of care which includes a one-time referral to community resources to meet their social needs. At three months they also begin the same child weight management group treatment as the experimental group. Receives: Behavioral: Child weight management intervention; Other: Standard of Care referral to resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
Number of participants enrolled (consented) per month
Measured: 1 year
Retention
Attendance at 6 month data assessment
Measured: 6 months
Satisfaction with Community Health Worker (CHW)
A 15-item scale asks about quality of interactions and satisfaction with their CHW. Scores range from 15 to 60, with higher scores indicating increased satisfaction.
Measured: 3 months
Satisfaction with PHIT Kids - Parent
A single 10-point Likert scale satisfaction rating about the group weight management intervention. Scores range from 1-10 with higher scores indicating increased satisfaction.
Measured: 6 months
Child Body Mass Index (BMI) Z-Score
6 months
Measured: Change in BMI Z-score over a 6 month time period in the child with obesity or overweight
Inhibitory Control and Attention
The Flanker Inhibitory and Control Attention Test (Flanker) measures accuracy and reaction time to produce a combined score ranging from 0-10 with higher scores indicating better inhibitory control and attention.
Measured: 3 months
Working Memory
The List Sorting Working Memory Test asks participants to recall a list of foods and animals in order from smallest to largest. Correct responses range from 0-26, and are then converted to nationally normed standard scores ranging from 59-140, with higher scores indicating better working memory.
Measured: 3 months
Cognitive Flexibility
The Dimensional Change Card Sort Test (DCCS) measures accuracy and reaction time to produce a combined score ranging from 0-10 with higher scores indicating better cognitive flexibility.
Measured: 3 months
Parent Cognitive Capacity
The Raven's 2 Progressive Matrices- Digital Short Form (Raven's 2) tests fluid intelligence by asking participants to identify missing pieces in visual geometric patterns of up to 24 progressively more difficult trials. The total number correct is converted into Standard Scores, which will be compared to a participant's other scores over the course of the study. Standard scores range from 59-140 with higher scores indicating increased cognitive capacity.
Measured: 3 months
Secondary outcomes (8)
PHIT Kids attendance
percent of PHIT Kids sessions attended
Measured: 6 months
Percentage of needs met or partially met
At 3 months, participants will review each need identified at baseline and report if they received "All the help I needed," "Most of the help I needed," "A little of the help I needed," or "None of the help I needed." The total number of needs that were at least partially met ("a little", "most" or "all") or that were fully met ("all") will be divided by the total number of needs at baseline
Measured: 3 months
Enrollment in at least one new resource
Yes/No. Family has accessed at 3 months at least one new community or government resource since baseline. Participants will review a list of resources potentially offered to CHW clients and respond whether they currently receive this resource at baseline and 3 months
Measured: 3 months
Number of key measures completed
Number of the following measures completed - outcome measures (child BMI-z, parent weight, MVPA (actigraph; at least 4 days), dietary measures (3 recalls)), bandwidth measures (executive functions measures and Raven matrices) and self-efficacy.
Measured: 6 months
Parent Weight
Change in parent weight at 6 month and 12 months
Measured: 6 months and 12 months
Child Moderate to Vigorous Physical Activity (MVPA)
Minutes per week in moderate to vigourous physical activity as measure by an Actigraph waist accelerometer worn by the child. Also percent of time in MVPA
Measured: 6 months and 12 months
Child Dietary Intake
Three 24 hour recalls completed by parent using the he Automated Self-Administered 24-hour Dietary Assessment Tool (ASA 24) computer program - used to calculate fruit and vegetable (FV) servings, sugar sweetened beverages, and number of high fat/high sugar foods (foods with >7g of fat and/or 12g of sugar)
Measured: 6 months and 12 months
Self-Efficacy
10-item, 5-point Likert scale. Measured by the General Self-Efficacy Scale in the NIH Toolbox. This scale assesses an individual's perceived ability to cope with stressful situations. Scores range from 10 to 50 with higher scores indicating higher self-efficacy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start3 Jan 2025
- Primary completion23 Jun 2026
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 60 Families (2 participants in each- parent and child) will be randomized to community health worker intervention or standard social risk factor (SRF) referral for the first 3 months and then 3-6 months both groups will do the same child obesity intervention then 6-12 months both will receive no intervention.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Community Health Council of Wyandotte County, University of Kansas Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Helena Laroche, MD, Children's Mercy Hospital Kansas City
- Investigators
- Helena Laroche, MD, Principal investigator, Children's Mercy Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520657
- Sponsor's protocol ID
- STUDY00002819
- Other IDs
- 1R01DK139363-01
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Social Determinants of Health in Child Obesity Treatment Using Community Health Workers: the Role of Parental Bandwidth in Treatment Effectiveness
- ClinicalTrials.gov ID
- NCT06520657
- Acronym / sponsor ID
- STUDY00002819
- Conditions
- Child Obesity, Social Determinants of Health
- Keywords
- Community Health Workers, Randomized trial, Pilot Study, Child Obesity Treatment, Executive function
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- Community Health Council of Wyandotte County, University of Kansas Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 23 Jun 2026 (actual)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 25 Jul 2024 (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 goal of this small pilot study is to test the feasibility of combining a three-month intervention of working with a community health worker (CHW) to address social risk factors for patients prior to beginning a group weight management program for childhood obesity -- Promoting Health in Teens and Kids (PHIT Kids)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 60 Families (2 participants in each- parent and child) will be randomized to community health worker intervention or standard social risk factor (SRF) referral for the first 3 months and then 3-6 months both groups will do the same child obesity intervention then 6-12 months both will receive no intervention.
| Arm | Type | Receives |
|---|---|---|
| CHW plus child weight management intervention | Experimental | Other: Community Health Worker, Behavioral: Child weight management intervention, Other: Standard of Care referral to resourcesParticipants in this arm will work with a community health worker for three months to address social risk factors (negative social determinants of health) prior to beginning a child weight management group treatment. |
| Child weight management intervention only | Active comparator | Behavioral: Child weight management intervention, Other: Standard of Care referral to resourcesParticipants in this arm will receive the standard of care which includes a one-time referral to community resources to meet their social needs. At three months they also begin the same child weight management group treatment as the experimental group. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Family must have one major social risk factor on the Protocol for Responding to \& Assessing Patients' Assets, Risks \& Experiences (PRAPARE) of the 14 modifiable risk factors
- Child aged 8 through 12 years of age
- Child with BMI% at 85th percentile or higher and less than the 120% of the 95th percentile (overweight or class 1 obesity)
- Child must live with parent/guardian at least 5 out of the 7 days on average (70% of the time)
- Child and parent able to speak English
Key exclusion criteria (7 listed)
- Child on medications known to cause ongoing weight gain (e.g., atypical anti-psychotics, chronic prednisone, insulin)
- Child on other medications know to affect weight if dose and BMI z-score has not been stable for 3 months.
- Diabetes or other disease that has a significant effect on diet, physical activity, or ability to take part in trial activities besides obesity (does not included treated or mild depression or anxiety, limited food allergies or mild physical activity limitations)
- For parents: new MI, stroke or cancer diagnosis (excluding localized skin cancers) in past 6 months, history of bariatric surgery within the past 3 years, pregnancy in last 6 months or planned within 1 year
- Child or parent has significant developmental or cognitive impairments or other significant medical issue that would interfere with ability to participate or complete assessment
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 |
|---|---|---|
| Community Health WorkerParticipants are screened for social determinants of health and work with a community health worker for three months to connect them with community and government services to address their family's needs. | Other | CHW plus child weight management intervention |
| Child weight management interventionThis is a 12-week family-based behavioral group intervention to address childhood overweight and obesity. | Behavioural | CHW plus child weight management intervention, Child weight management intervention only |
| Standard of Care referral to resourcesOne-time referral to resources based on need that families can access independently either by providing electronic referral to or providing written contact information for a community resource. | Other | CHW plus child weight management intervention, Child weight management intervention only |
Primary outcome
Enrollment Rate
Time frame: 1 year
Number of participants enrolled (consented) per month
Retention
Time frame: 6 months
Attendance at 6 month data assessment
Satisfaction with Community Health Worker (CHW)
Time frame: 3 months
A 15-item scale asks about quality of interactions and satisfaction with their CHW. Scores range from 15 to 60, with higher scores indicating increased satisfaction.
Satisfaction with PHIT Kids - Parent
Time frame: 6 months
A single 10-point Likert scale satisfaction rating about the group weight management intervention. Scores range from 1-10 with higher scores indicating increased satisfaction.
Child Body Mass Index (BMI) Z-Score
Time frame: Change in BMI Z-score over a 6 month time period in the child with obesity or overweight
6 months
Inhibitory Control and Attention
Time frame: 3 months
The Flanker Inhibitory and Control Attention Test (Flanker) measures accuracy and reaction time to produce a combined score ranging from 0-10 with higher scores indicating better inhibitory control and attention.
Working Memory
Time frame: 3 months
The List Sorting Working Memory Test asks participants to recall a list of foods and animals in order from smallest to largest. Correct responses range from 0-26, and are then converted to nationally normed standard scores ranging from 59-140, with higher scores indicating better working memory.
Cognitive Flexibility
Time frame: 3 months
The Dimensional Change Card Sort Test (DCCS) measures accuracy and reaction time to produce a combined score ranging from 0-10 with higher scores indicating better cognitive flexibility.
Parent Cognitive Capacity
Time frame: 3 months
The Raven's 2 Progressive Matrices- Digital Short Form (Raven's 2) tests fluid intelligence by asking participants to identify missing pieces in visual geometric patterns of up to 24 progressively more difficult trials. The total number correct is converted into Standard Scores, which will be compared to a participant's other scores over the course of the study. Standard scores range from 59-140 with higher scores indicating increased cognitive capacity.
8 secondary outcomes
PHIT Kids attendance
Time frame: 6 months
Percentage of needs met or partially met
Time frame: 3 months
Enrollment in at least one new resource
Time frame: 3 months
Number of key measures completed
Time frame: 6 months
Parent Weight
Time frame: 6 months and 12 months
Child Moderate to Vigorous Physical Activity (MVPA)
Time frame: 6 months and 12 months
Child Dietary Intake
Time frame: 6 months and 12 months
Self-Efficacy
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Helena Laroche, MD principal investigator
Children's Mercy Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker and Child weight management intervention in people with Child Obesity and Social Determinants of Health, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Enrollment Rate (time frame: 1 year). The study lists 9 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 9 Sep 2026.