Obesity, ChildhoodTEAM UPNCT03843424
Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers
A study testing eSOC program and FBT program in people with Obesity, Childhood and Pediatric Obesity, run by Washington University School of Medicine at 7 sites in United States.
Trial summary
The US Preventive Services Task Force (USPSTF) recommends that providers screen children aged 6 years and older for obesity and offer or refer them to a comprehensive behavioral intervention (≥26 hours over a period of up to 12 months) to promote improvement in weight status. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Pediatric Obesity, Childhood Obesity
- What is being tested?
- eSOC program and FBT program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,460 participants
- Where
- 7 sitesUnited States
- Study dates
- 12 Sep 2019to 26 Jul 2024
- 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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- have a BMI percentile ≥95th for age and sex;
- comfortable speaking English language;
- able to provide written or verbal (based on age) informed assent;
- willing to change diet, physical activity, and/or weight;
- patient of a participating clinic/practice; and
- able to participate in scheduled sessions.
- comfortable speaking and reading English language.
Who cannot join
- families who plan to no longer have the child be a patient of any participating clinic/practice during any point in the 18-month study period;
- children with chronic conditions or on medications that substantially impact or interfere with growth, appetite, weight, or physical activity participation;
- families for whom the Primary Care Provider (PCP) or site PI thinks the intervention is clinically/medically inappropriate (e.g., developmental delay, or emotional or cognitive difficulties, if the PI/PCP believes these factors will interfere with study/intervention participation); and
- families in whom the parent or child exhibits eating disorder symptomatology.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Washington University School of Medicine
Alton, Illinois, 62002
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Washington University School of Medicine
Cape Girardeau, Missouri, 63703
University of Missouri School of Medicine
Columbia, Missouri, 65201
Pennington Biomedical Research Center
New Orleans, Louisiana, 70121
University of Rochester Medical Center
Rochester, New York, 14642
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Pragmatic Family-Centered Approach to Childhood Obesity Treatment
The US Preventive Services Task Force (USPSTF) recommends that providers screen children aged 6 years and older for obesity and offer or refer them to a comprehensive behavioral intervention (≥26 hours over a period of up to 12 months) to promote improvement in weight status. Family-based behavioral treatment (FBT) is an effective treatment that targets both child and parents and meets the USPSTF recommendations. By contrast, the American Medical Association (AMA) recommends a staged approach to childhood obesity screening and counseling, which begins with prevention counseling by the primary care provider (PCP) and includes assessment of weight status, patient/family motivation and readiness to change, promotion of healthy eating and activity habits, and use of health behavior change strategies. Our study compares a staged approach enhanced standard of care (eSOC) vs. eSOC + FBT, to provide families and PCPs with information on the best intervention approach for the behavioral treatment of childhood obesity. Our project seeks to fill the gap in the evidence on family-based weight management in primary care settings among diverse and underserved populations with a special focus on Black children, families insured by Medicaid, and sex differences.
Read the detailed description
Note: our enrollment number includes two participants (one child and one parent) from each enrolled family.
- Conditions
- Obesity, Childhood, Pediatric Obesity, Childhood Obesity, Adolescent Obesity, Overweight, Overweight and Obesity
- Being tested
- eSOC program, FBT program
- Keywords
- Weight Management, Child, Intervention, Weight Loss, Behavior Therapy, Nutrition
- Medical subject headings
- Pediatric Obesity, Overweight, Obesity, Weight Gain, Overnutrition, Body Weight, Body Weight Changes, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSOC programBehavioural
American Medical Association (AMA) recommended staged approach to childhood obesity screening and counseling
FBT programBehavioural
An intensive,comprehensive, behavioral intervention aligned with the US Preventive Services Task Force recommendations for childhood obesity screening and counseling.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Standard of Care (eSOC) | Active comparator | This group will receive the eSOC program. A minimum of 6 visits to the primary care provider (PCP) and includes assessment of weight status, patient/family motivation and readiness to change, promotion of healthy eating and activity habits, and use of health behavior change strategies. Receives: Behavioral: eSOC program |
| Family-Based Behavioral Treatment (FBT + eSOC) | Active comparator | This group will receive eSOC plus the FBT program. Family-based behavioral treatment (FBT), an effective treatment that targets both child and parents meeting regularly with a health coach for healthy eating, activity, positive parenting strategies, and managing environmental cues. Receives: Behavioral: eSOC program; Behavioral: FBT program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child percent overweight
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start12 Sep 2019
- Primary completion26 Jun 2024
- Study completion26 Jul 2024
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 Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Blue Cross Blue Shield, American Academy of Pediatrics, Pennington Biomedical Research Center, Louisiana Healthcare Connections, Nationwide Children's Hospital, University of Rochester
- Responsible party
- Sponsor
- Investigators
- Denise E. Wilfley, PhD, Principal investigator, Washington University School of MedicineStephen Cook, MD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843424
- Sponsor's protocol ID
- 201810158
- Other IDs
- PCS-2017C2-7542
- Acronym
- TEAM UP
- Status last verified
- Sep 2024
- First submitted
- 14 Feb 2019
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Staiano AE, Cook SR, Stein RI, Button AM, Newton RL Jr, Beyl RA, Baker A, Lindros J, Conn AM, Braddock AS, Welch RR, Wilfley DE; TEAM UP Research Group. Family-Centered Child Obesity Treatment: The TEAM UP Randomized Clinical Trial. JAMA Pediatr. 2026 Jul 27:e263067. doi: 10.1001/jamapediatrics.2026.3067. Online ahead of print.
PubMed 42507462Staiano AE, Button AM, Baker A, Beyl R, Conn AM, Lima A, Lindros J, Newton RL Jr, Stein RI, Welch RR, Cook S, Wilfley DE; TEAM UP Research Group. A pragmatic trial of a family-centered approach to childhood obesity treatment: Rationale and study design. Contemp Clin Trials. 2024 Mar;138:107459. doi: 10.1016/j.cct.2024.107459. Epub 2024 Jan 24.
PubMed 38278478
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Family-Centered Approach to Childhood Obesity Treatment
- ClinicalTrials.gov ID
- NCT03843424
- Acronym / sponsor ID
- TEAM UP / 201810158
- Conditions
- Obesity, Childhood, Pediatric Obesity, Childhood Obesity, Adolescent Obesity, Overweight, Overweight and Obesity
- Keywords
- Weight Management, Child, Intervention, Weight Loss, Behavior Therapy, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,460 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Blue Cross Blue Shield, American Academy of Pediatrics, Pennington Biomedical Research Center, Louisiana Healthcare Connections, Nationwide Children's Hospital, University of Rochester
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 18 Feb 2019 (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 US Preventive Services Task Force (USPSTF) recommends that providers screen children aged 6 years and older for obesity and offer or refer them to a comprehensive behavioral intervention (≥26 hours over a period of up to 12 months) to promote improvement in weight status. Family-based behavioral treatment (FBT) is an effective treatment that targets both child and parents and meets the USPSTF recommendations. By contrast, the American Medical Association (AMA) recommends a staged approach to childhood obesity screening and counseling, which begins with prevention counseling by the primary care provider (PCP) and includes assessment of weight status, patient/family motivation and readiness to change, promotion of healthy eating and activity habits, and use of health behavior change strategies. Our study compares a staged approach enhanced standard of care (eSOC) vs. eSOC + FBT, to provide families and PCPs with information on the best intervention approach for the behavioral treatment of childhood obesity. Our project seeks to fill the gap in the evidence on family-based weight management in primary care settings among diverse and underserved populations with a special focus on Black children, families insured by Medicaid, and sex differences.
Detailed description
Note: our enrollment number includes two participants (one child and one parent) from each enrolled family.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Standard of Care (eSOC) | Active comparator | Behavioral: eSOC programThis group will receive the eSOC program. A minimum of 6 visits to the primary care provider (PCP) and includes assessment of weight status, patient/family motivation and readiness to change, promotion of healthy eating and activity habits, and use of health behavior change strategies. |
| Family-Based Behavioral Treatment (FBT + eSOC) | Active comparator | Behavioral: eSOC program, Behavioral: FBT programThis group will receive eSOC plus the FBT program. Family-based behavioral treatment (FBT), an effective treatment that targets both child and parents meeting regularly with a health coach for healthy eating, activity, positive parenting strategies, and managing environmental cues. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- have a BMI percentile ≥95th for age and sex;
- comfortable speaking English language;
- able to provide written or verbal (based on age) informed assent;
- willing to change diet, physical activity, and/or weight;
- patient of a participating clinic/practice; and
Key exclusion criteria (4 listed)
- families who plan to no longer have the child be a patient of any participating clinic/practice during any point in the 18-month study period;
- children with chronic conditions or on medications that substantially impact or interfere with growth, appetite, weight, or physical activity participation;
- families for whom the Primary Care Provider (PCP) or site PI thinks the intervention is clinically/medically inappropriate (e.g., developmental delay, or emotional or cognitive difficulties, if the PI/PCP believes these factors will interfere with study/intervention participation); and
- families in whom the parent or child exhibits eating disorder symptomatology.
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 |
|---|---|---|
| eSOC programAmerican Medical Association (AMA) recommended staged approach to childhood obesity screening and counseling | Behavioural | Enhanced Standard of Care (eSOC), Family-Based Behavioral Treatment (FBT + eSOC) |
| FBT programAn intensive,comprehensive, behavioral intervention aligned with the US Preventive Services Task Force recommendations for childhood obesity screening and counseling. | Behavioural | Family-Based Behavioral Treatment (FBT + eSOC) |
Primary outcome
Child percent overweight
Time frame: 1 year
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 1 Oct 2024.
- Derived from this study: PubMed 42507462Staiano AE, Cook SR, Stein RI, Button AM, Newton RL Jr, Beyl RA, Baker A, Lindros J, Conn AM, Braddock AS, Welch RR, Wilfley DE; TEAM UP Research Group. Family-Centered Child Obesity Treatment: The TEAM UP Randomized Clinical Trial. JAMA Pediatr. 2026 Jul 27:e263067. doi: 10.1001/jamapediatrics.2026.3067. Online ahead of print.
- Derived from this study: PubMed 38278478Staiano AE, Button AM, Baker A, Beyl R, Conn AM, Lima A, Lindros J, Newton RL Jr, Stein RI, Welch RR, Cook S, Wilfley DE; TEAM UP Research Group. A pragmatic trial of a family-centered approach to childhood obesity treatment: Rationale and study design. Contemp Clin Trials. 2024 Mar;138:107459. doi: 10.1016/j.cct.2024.107459. Epub 2024 Jan 24.
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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.
Denise E. Wilfley, PhD principal investigator
Washington University School of Medicine
Stephen Cook, MD, MPH principal investigator
University of Rochester
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eSOC program and FBT program in people with Obesity, Childhood and Pediatric Obesity, run by Washington University School of Medicine at 7 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 7 inclusion and 4 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Child percent overweight (time frame: 1 year). 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 NCT03843424, 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 1 Oct 2024.