Obesity, ChildhoodNCT05950620
Bringing Weight Management Into the Primary Care Pediatric Practice
An observational study of Obesity, Childhood, run by Oregon Health and Science University at 2 sites in United States.
Trial summary
This project aims to move what is currently a specialty-care model for the management of obesity of children and adolescents into the primary care setting. Read more about this study
- Who is it for?
- Ages 1 month to 21 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Medical obesity management.
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2022to 30 Jun 2026
- Phase
- Observational
- 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 1 month to 21 years
- All sexes
- Child, Adult
Study population: Patients in a general pediatrician's office internally in Portland, Oregon.
Who may be able to join
- Children with obesity (BMI > 30 kg/m2 or > 95th percentile) or in need of weight management of unwanted weight gain.
Who cannot join
- None.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Recruiting
The Children's Clinic
Portland, Oregon, 97225
Susanne Purnell, 503-297-3371, spurnell@childrens-clinic.com
- Active, not recruiting
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Pilot and Feasibility Project to Establish a Childhood Nutrition and Health Clinic Managing Weight and Obesity Complications in a Primary Care Pediatric Practice
This project aims to move what is currently a specialty-care model for the management of obesity of children and adolescents into the primary care setting.
Read the detailed description
The goal of this project is to create a sustainable clinical model in the primary care setting that improves nutritional health, lessens obesity, and addresses weight-related complications of children and adolescents to reduce risk for metabolic disease in later life. The primary objectives include tracking changes in BMI (both absolute and percentile) and levels of hemoglobin A1c, liver enzymes (AST, ALT levels), and lipids in patients seen in a primary care setting by a general pediatrician board-certified in obesity medicine. Secondary objectives include tracking patient adherence, follow-up, and retention.
- Conditions
- Obesity, Childhood
- Being tested
- Medical obesity management.
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical obesity management.Other
Dietician visits, education, anti-obesity medications, and/or referral for metabolic-bariatric surgery as indicated by American Academy of Pediatrics guidelines for obesity management.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Pediatric patients with obesity or in need of weight management for unwanted weight gain. Receives: Other: Medical obesity management. | |
| Controls | Historic controls matched to the Intervention group on age, sex, and BMI percentile. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Body weight in kg
Measured: Baseline to follow-up (1-3 years)
Change in body height
Body height in meters
Measured: Baseline to follow-up (1-3 years)
Change in BMI
BMI will be calculated using the formula: kg weight / m2 height. Will be in both absolute and percentile for age
Measured: Baseline to follow-up (1-3 years)
Impact on glucose control
Hemoglobin A1c levels
Measured: Baseline to follow-up (1-3 years)
Impact on fatty liver
Levels of liver enzymes ALT, AST
Measured: Baseline to follow-up (1-3 years)
Impact on lipid levels
Levels of total, LDL, HDL, and non-HDL cholesterol. Triglycerides.
Measured: Baseline to follow-up (1-3 years)
Secondary outcomes (1)
Patient follow-up metrics
Patient clinical follow-up rate, medication adherence, and retention
Measured: Baseline to follow-up (1-3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Jul 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- William H. Hurt Foundation
- Responsible party
- Principal investigator, Jonathan Purnell, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950620
- Sponsor's protocol ID
- IRB 24927
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study uses anonymized data. No IPD will be generated.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot and Feasibility Project to Establish a Childhood Nutrition and Health Clinic Managing Weight and Obesity Complications in a Primary Care Pediatric Practice
- ClinicalTrials.gov ID
- NCT05950620
- Acronym / sponsor ID
- IRB 24927
- Conditions
- Obesity, Childhood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- William H. Hurt Foundation
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Jul 2023 (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.
This project aims to move what is currently a specialty-care model for the management of obesity of children and adolescents into the primary care setting.
Detailed description
The goal of this project is to create a sustainable clinical model in the primary care setting that improves nutritional health, lessens obesity, and addresses weight-related complications of children and adolescents to reduce risk for metabolic disease in later life. The primary objectives include tracking changes in BMI (both absolute and percentile) and levels of hemoglobin A1c, liver enzymes (AST, ALT levels), and lipids in patients seen in a primary care setting by a general pediatrician board-certified in obesity medicine. Secondary objectives include tracking patient adherence, follow-up, and retention.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: Medical obesity management.Pediatric patients with obesity or in need of weight management for unwanted weight gain. |
| Controls | – | –Historic controls matched to the Intervention group on age, sex, and BMI percentile. |
Who may qualify
- Ages
- 1 month to 21 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients in a general pediatrician's office internally in Portland, Oregon.
Key inclusion criteria (1 listed)
- Children with obesity (BMI > 30 kg/m2 or > 95th percentile) or in need of weight management of unwanted weight gain.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Medical obesity management.Dietician visits, education, anti-obesity medications, and/or referral for metabolic-bariatric surgery as indicated by American Academy of Pediatrics guidelines for obesity management. | Other | Intervention |
Primary outcome
Change in body weight
Time frame: Baseline to follow-up (1-3 years)
Body weight in kg
Change in body height
Time frame: Baseline to follow-up (1-3 years)
Body height in meters
Change in BMI
Time frame: Baseline to follow-up (1-3 years)
BMI will be calculated using the formula: kg weight / m2 height. Will be in both absolute and percentile for age
Impact on glucose control
Time frame: Baseline to follow-up (1-3 years)
Hemoglobin A1c levels
Impact on fatty liver
Time frame: Baseline to follow-up (1-3 years)
Levels of liver enzymes ALT, AST
Impact on lipid levels
Time frame: Baseline to follow-up (1-3 years)
Levels of total, LDL, HDL, and non-HDL cholesterol. Triglycerides.
1 secondary outcome
Patient follow-up metrics
Time frame: Baseline to follow-up (1-3 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: No. This study uses anonymized data. No IPD will be generated.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Childhood, run by Oregon Health and Science University at 2 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 1 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: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Q Purnell, MD (503-494-1056, purnellj@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Baseline to follow-up (1-3 years)). The study lists 6 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 19 Jul 2023.