Pediatric ObesityNCT05455190
Parks & Pediatrics Fit Together
A study testing Fit Together and Educational materials in people with Pediatric Obesity and Implementation, run by Duke University at 3 sites in United States.
Trial summary
The proposed project will test an implementation strategy (the "TrailGuide") for delivering an existing model of pediatric obesity treatment ("Fit Together") that has demonstrated ability to meet published recommendations for improving health outcomes of children with obesity. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Pediatric Obesity, Implementation
- What is being tested?
- Fit Together and Educational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Dec 2022to 6 Jul 2026
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child receives primary care at one of the participating clinics
- Child age 5-12 years old at the time of enrollment in the study
- BMI greater than or equal to 95th percentile for age and sex (or greater than or equal to 85th%ile at the discretion of the provider)
- English- or Spanish-speaking
- Age 18 or older
- English or Spanish-speaking
Show all 17Show fewer
- Caregiver has smartphone and is willing to download app(s) used in the study
- Anticipates bringing the child to the program the majority of the time and spends significant time with the child outside of program hours (necessary in order to accurately answer survey questions about child behavior and child participation in the program, and provide feedback about the program)
- Does not have plans to move out of the area during the duration of the study (12 months)
- Durham Cohort:
- Child is a Healthy Lifestyles patient and has been referred to Bull City Fit
- Child is 5-12 years old at the time of enrollment in the study Child BMI is greater than or equal to the 95th %ile (An exception may be made if BMI is now below the 95th%ile, but was > 95th%ile at the time they started attending Healthy Lifestyles/Bull City Fit. An exception may also be made if BMI was below the 95th%ile but > 85th%ile and obesity treatment/program participation is clinically indicated (e.g., provider still referred them to Healthy Lifestyles and their HL provider referred them to BCF))
- Child and parent are English- or Spanish-speaking
- Child does not have an injury or disability preventing them for engaging in physical activity -- if a child meets this exclusion criteria at the time of referral but is expected to recover/heal (e.g., sprained ankle), they may enroll once healed and cleared to resume physical activity.
- Caregiver age 18 or older
- Caregiver anticipates bringing the child to the program the majority of the time and spends significant time with the child outside of program hours
- Does not have plans to move out of the area during the next 6 months If multiple siblings from one household are eligible and would like to participate, more than one child may be enrolled.
Who cannot join
- Injuries or disabilities preventing physical activity.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Michael Jordan Family Medical Clinic (Freedom Drive Location) (NHPMCF)
Charlotte, North Carolina, 28208
Duke University
Durham, North Carolina, 27710
Waughtown Pediatrics (NHFMCF)
Winston-Salem, North Carolina, 27107
About this study
Official title: Parks & Pediatrics Fit Together: Translating Knowledge Into Action for Child Obesity Treatment in Partnership With Parks and Recreation
The proposed project will test an implementation strategy (the "TrailGuide") for delivering an existing model of pediatric obesity treatment ("Fit Together") that has demonstrated ability to meet published recommendations for improving health outcomes of children with obesity.
Read the detailed description
Evidence-based treatment for childhood obesity exists, yet a fundamental knowledge-to-action gap has significantly limited the uptake of recommendations into clinical practice, particularly in low-income settings. Persistence of this gap represents a large-scale public health threat, as the earliest generation of children living through the obesity epidemic now enters adulthood, they are the first in US history to have a shorter life expectancy than their parents, mainly due to rising rates of obesity-related cancers and cardiovascular disease. A central challenge in delivering recommended treatment is the intensity; ≥26 hours of face-to-face contact are necessary to achieve health benefits and risk reduction. The objective of the proposed project is to develop and test an implementation strategy that pairs primary care pediatric clinics with the municipal Parks and Recreation (P\&R) centers to deliver the current treatment recommendations with high fidelity, while allowing while allowing crucial adaptations for the local and cultural context. Using the Fit Together model, the clinical partner provides standard medical treatment for pediatric obesity, while the community partner (typically parks and recreation) provides space facilitating the activity/nutrition sessions specifically for children referred from the clinic, along with their families. Fit Together will be implemented in two new communities in North Carolina, and investigators will study implementation outcomes as well as 12-month patient outcomes. A local cohort has been added in Durham, North Carolina, where their local Fit Together model has re-started their community activity program, and investigators will look at 6-month patient outcomes.
- Conditions
- Pediatric Obesity, Implementation
- Being tested
- Fit Together, Educational materials
- Keywords
- Physical Activity, Pediatrics
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit TogetherBehavioural
Fit Together intervention follows a clinic and community partnership model for childhood obesity treatment. Children with obesity will receive standard of care obesity treatment from their usual provider and will also receive a referral to an activity program run out of the local community center. Each session delivers a combination of high-intensity individual exercises, sports and games, and unstructured playtime to help children reach the US Physical Activity guidelines of 60min moderate-to-vigorous physical activity daily. There will also be a nutrition activity session offered regularly.
Educational materialsBehavioural
Participants will receive a child-friendly cooking magazine mailed quarterly and a local Parks and Recreation program guide.
| Study group | Role | What they receive |
|---|---|---|
| Fit Together | Experimental | Participants in the intervention arm will receive standard of care obesity treatment from their provider and be able to participate in the Fit Together program and attend activity sessions throughout the duration of their 12 month participation. Receives: Behavioral: Fit Together |
| Control | Active comparator | Participants in the control arm will receive standard of care obesity treatment from their provider and a healthy cooking magazine mailed to them at a regular interval throughout the duration of their 12 month participation Receives: Behavioral: Educational materials |
| Fit Together - BCF Cohort | Experimental | Participants in the Fit Together - BCF Cohort arm will receive standard of care obesity treatment at the Duke Healthy Lifestyles clinic and attend Bull City Fit throughout the duration of their 6 month participation Receives: Behavioral: Fit Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent of the 95th percentile for BMI Collected from clinic records.
Change in child's BMI, based on percent of the 95th percentile, measured using height and weight collected from clinic/medical records
Measured: Baseline, 3 months, 6 months, and 12 months
Proportion of children with 26 hours or more of intervention contact
Measured by program attendance
Measured: Up to 12 months
Change in number of combined minutes per day of moderate and vigorous physical activity, as measured by Garmin vivofit4 fitness tracker
Change in physical activity measured by Garmin vivofit4 fitness tracker
Measured: Baseline up to 12 months
Secondary outcomes (8)
Change in self-report physical activity
Measured by the Evaluation of Activity Surveys in Youth (EASY); Scoring: range 0-88, higher scores indicate more activity
Measured: Baseline, 6 months, and 12 months
Change in quality of life
Measured by Sizing Them Up; Scoring: range 0-100, higher scores indicate better health-related quality of life
Measured: Baseline, 6 months, and 12 months
Unintended Consequences as measured by adverse events
Measured by collecting adverse events throughout participation
Measured: Up to 12 months
Patient Satisfaction at 3 months
Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction
Measured: 3 months
Patient Satisfaction at 6 months
Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction
Measured: 6 months
Patient Satisfaction at 12 months
Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction
Measured: 12 months
Change in diet quality
Measured by the Dietary Screener Questionnaire (DSQ)
Measured: Baseline, 6 months, 12 months
Physical activity during program sessions measured by accelerometer
Measured by the average number of minutes of moderate to vigorous physical activity (MVPA) per session.
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 posted13 Jul 2022
- Study start15 Dec 2022
- Primary completion6 Jul 2026
- Study completion6 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455190
- Sponsor's protocol ID
- Pro00106453
- Other IDs
- 1R01HD100417-01A1
- Status last verified
- Mar 2026
- First submitted
- 1 Jul 2022
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'Agostino EM, Rosenberg LM, Richmond A, Damman A, Brown-Lowery C, Abbot-Grimes P, Siddiqui S, Fadika T, Ward M, Cooper M, Sutton S, Kenton L, Spaziano B, Kasper J, Barnes N, Hornik C. You & Me: Test and Treat study protocol for promoting COVID-19 test and treatment access to underserved populations. BMC Public Health. 2023 Oct 28;23(1):2121. doi: 10.1186/s12889-023-16960-6.
PubMed 37898741Neshteruk CD, Skinner AC, Counts J, D'Agostino EM, Frerichs L, Howard J, Story M, Armstrong SC. Translating knowledge into action for child obesity treatment in partnership with Parks and Recreation: study protocol for a hybrid type II trial. Implement Sci. 2023 Feb 24;18(1):6. doi: 10.1186/s13012-023-01264-5.
PubMed 36829237
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parks & Pediatrics Fit Together: Translating Knowledge Into Action for Child Obesity Treatment in Partnership With Parks and Recreation
- ClinicalTrials.gov ID
- NCT05455190
- Acronym / sponsor ID
- Pro00106453
- Conditions
- Pediatric Obesity, Implementation
- Keywords
- Physical Activity, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 6 Jul 2026 (actual)
- Study completion
- 6 Jul 2026 (actual)
- First posted
- 13 Jul 2022 (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 proposed project will test an implementation strategy (the "TrailGuide") for delivering an existing model of pediatric obesity treatment ("Fit Together") that has demonstrated ability to meet published recommendations for improving health outcomes of children with obesity.
Detailed description
Evidence-based treatment for childhood obesity exists, yet a fundamental knowledge-to-action gap has significantly limited the uptake of recommendations into clinical practice, particularly in low-income settings. Persistence of this gap represents a large-scale public health threat, as the earliest generation of children living through the obesity epidemic now enters adulthood, they are the first in US history to have a shorter life expectancy than their parents, mainly due to rising rates of obesity-related cancers and cardiovascular disease. A central challenge in delivering recommended treatment is the intensity; ≥26 hours of face-to-face contact are necessary to achieve health benefits and risk reduction. The objective of the proposed project is to develop and test an implementation strategy that pairs primary care pediatric clinics with the municipal Parks and Recreation (P\&R) centers to deliver the current treatment recommendations with high fidelity, while allowing while allowing crucial adaptations for the local and cultural context. Using the Fit Together model, the clinical partner provides standard medical treatment for pediatric obesity, while the community partner (typically parks and recreation) provides space facilitating the activity/nutrition sessions specifically for children referred from the clinic, along with their families. Fit Together will be implemented in two new communities in North Carolina, and investigators will study implementation outcomes as well as 12-month patient outcomes. A local cohort has been added in Durham, North Carolina, where their local Fit Together model has re-started their community activity program, and investigators will look at 6-month patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fit Together | Experimental | Behavioral: Fit TogetherParticipants in the intervention arm will receive standard of care obesity treatment from their provider and be able to participate in the Fit Together program and attend activity sessions throughout the duration of their 12 month participation. |
| Control | Active comparator | Behavioral: Educational materialsParticipants in the control arm will receive standard of care obesity treatment from their provider and a healthy cooking magazine mailed to them at a regular interval throughout the duration of their 12 month participation |
| Fit Together - BCF Cohort | Experimental | Behavioral: Fit TogetherParticipants in the Fit Together - BCF Cohort arm will receive standard of care obesity treatment at the Duke Healthy Lifestyles clinic and attend Bull City Fit throughout the duration of their 6 month participation |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- Child receives primary care at one of the participating clinics
- Child age 5-12 years old at the time of enrollment in the study
- BMI greater than or equal to 95th percentile for age and sex (or greater than or equal to 85th%ile at the discretion of the provider)
- English- or Spanish-speaking
- Age 18 or older
Key exclusion criteria (1 listed)
- Injuries or disabilities preventing physical activity.
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 |
|---|---|---|
| Fit TogetherFit Together intervention follows a clinic and community partnership model for childhood obesity treatment. Children with obesity will receive standard of care obesity treatment from their usual provider and will also receive a referral to an activity program run out of the local community center. Each session delivers a combination of high-intensity individual exercises, sports and games, and unstructured playtime to help children reach the US Physical Activity guidelines of 60min moderate-to-vigorous physical activity daily. There will also be a nutrition activity session offered regularly. | Behavioural | Fit Together, Fit Together - BCF Cohort |
| Educational materialsParticipants will receive a child-friendly cooking magazine mailed quarterly and a local Parks and Recreation program guide. | Behavioural | Control |
Primary outcome
Change in percent of the 95th percentile for BMI Collected from clinic records.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change in child's BMI, based on percent of the 95th percentile, measured using height and weight collected from clinic/medical records
Proportion of children with 26 hours or more of intervention contact
Time frame: Up to 12 months
Measured by program attendance
Change in number of combined minutes per day of moderate and vigorous physical activity, as measured by Garmin vivofit4 fitness tracker
Time frame: Baseline up to 12 months
Change in physical activity measured by Garmin vivofit4 fitness tracker
8 secondary outcomes
Change in self-report physical activity
Time frame: Baseline, 6 months, and 12 months
Change in quality of life
Time frame: Baseline, 6 months, and 12 months
Unintended Consequences as measured by adverse events
Time frame: Up to 12 months
Patient Satisfaction at 3 months
Time frame: 3 months
Patient Satisfaction at 6 months
Time frame: 6 months
Patient Satisfaction at 12 months
Time frame: 12 months
Change in diet quality
Time frame: Baseline, 6 months, 12 months
Physical activity during program sessions measured by accelerometer
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Derived from this study: PubMed 37898741D'Agostino EM, Rosenberg LM, Richmond A, Damman A, Brown-Lowery C, Abbot-Grimes P, Siddiqui S, Fadika T, Ward M, Cooper M, Sutton S, Kenton L, Spaziano B, Kasper J, Barnes N, Hornik C. You & Me: Test and Treat study protocol for promoting COVID-19 test and treatment access to underserved populations. BMC Public Health. 2023 Oct 28;23(1):2121. doi: 10.1186/s12889-023-16960-6.
- Derived from this study: PubMed 36829237Neshteruk CD, Skinner AC, Counts J, D'Agostino EM, Frerichs L, Howard J, Story M, Armstrong SC. Translating knowledge into action for child obesity treatment in partnership with Parks and Recreation: study protocol for a hybrid type II trial. Implement Sci. 2023 Feb 24;18(1):6. doi: 10.1186/s13012-023-01264-5.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fit Together and Educational materials in people with Pediatric Obesity and Implementation, run by Duke University at 3 sites 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 17 inclusion and 1 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: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in percent of the 95th percentile for BMI Collected from clinic records. (time frame: Baseline, 3 months, 6 months, and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05455190, which also lists 2 linked publications.
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 17 Aug 2026.