ObesityDECODENCT07487584
Study of Genetics in Childhood Obesity
An observational study of Obesity, run by Georgina Yan.
Trial summary
Childhood obesity is a major and growing health concern in the UK. Around 1 in 7 children aged 2-15 are living with obesity, which can lead to serious health problems and early death later in life. Some children develop obesity very early, before the age of 5. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Obesity
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to Sep 2027
- Phase
- Observational
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants will be identified from paediatric tier 3 complications of excess weight (CEW) clinic services in England.
Who may be able to join
- Aged 2-18 years old
- Early onset of obesity (before 5 years old)
- Obesity (BMI SDS ≥3/ ≥99.6th percentile)
- Attended a Complications of Excess Weight (CEW) clinic appointment between 2021 and 2025 (inclusive) and had a genetic investigation (R149 and/or CGH) array
Who cannot join
- Onset of obesity after 5 years of age
- History of chemotherapy, radiotherapy, antipsychotics and steroid use (possible iatrogenic causes of obesity)
- Known diagnosis of craniopharyngioma or hypothalamic tumour
About this study
Official title: Defining the Etiology of Childhood Obesity Through DNA Exploration; a Study Investigating Clinical Application of Genetic Testing in Childhood Obesity
Childhood obesity is a major and growing health concern in the UK. Around 1 in 7 children aged 2-15 are living with obesity, which can lead to serious health problems and early death later in life. Some children develop obesity very early, before the age of 5. It is now recognised genes (the biological instructions that make up an individual) can play an important role alongside lifestyle and environment. Certain rare single-gene conditions ("monogenic obesity") can strongly influence a child's weight.
The NHS already offers genetic testing for children with severe early-onset obesity, but it is not known how useful these tests are in everyday clinical practice. This study will help answer that question.
Read more
The DECODE study will look back at information already collected from children aged 2-18 who attended specialist Complications of Excess Weight (CEW) clinics in England between 2021 and 2025. These clinics support children with severe obesity and related health problems. The study will include children whose obesity started before age 5 and who have already had one or both NHS genetic tests: the R149 obesity gene panel or a comparative genomic hybridisation (CGH) array (a test that looks for missing or extra pieces of DNA).
The aim is to find out how often these tests detect a genetic cause of obesity ("diagnostic yield") and whether certain clinical features-such as developmental delay, neurodivergence, short stature or different eating behaviours -help predict a positive result.
No new tests or visits are required for this study. Only anonymised information from medical records will be used. Around 500-800 children from up to ten hospitals are expected to be included.
The findings will help the NHS understand who benefits most from genetic testing and how results can guide treatment, support families, and shape future services.
- Conditions
- Obesity
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of R149 and CGH array genetic testing in patients with severe, early-onset obesity under specialist paediatric weight management services
Measured: 2021-2025
Secondary outcomes (1)
The association of clinical features in the history with a positive genetic diagnosis namely: developmental delay, neurodivergence, learning difficulties, short stature, appetite dysregulation and restricted diet.
Measured: 2021-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgina Yan
- Sponsor type
- University, hospital or other
- Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trust, Oxford University Hospitals NHS Trust, Manchester University NHS Foundation Trust, Birmingham Women's and Children's NHS Foundation Trust, Bristol Royal Hospital for Children, Frimley Park Hospital NHS Trust, Dartford and Gravesham NHS Foundation Trust, Portsmouth Hospitals NHS Trust, Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor-investigator, Georgina Yan, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487584
- Sponsor's protocol ID
- RHM CHI1328
- Other IDs
- 361434
- Acronym
- DECODE
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Etiology of Childhood Obesity Through DNA Exploration; a Study Investigating Clinical Application of Genetic Testing in Childhood Obesity
- ClinicalTrials.gov ID
- NCT07487584
- Acronym / sponsor ID
- DECODE / RHM CHI1328
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Georgina YanUniversity, hospital or other
- Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trust, Oxford University Hospitals NHS Trust, Manchester University NHS Foundation Trust, Birmingham Women's and Children's NHS Foundation Trust, Bristol Royal Hospital for Children, Frimley Park Hospital NHS Trust, Dartford and Gravesham NHS Foundation Trust, Portsmouth Hospitals NHS Trust, Nottingham University Hospitals NHS Trust
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Mar 2026 (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.
Childhood obesity is a major and growing health concern in the UK. Around 1 in 7 children aged 2-15 are living with obesity, which can lead to serious health problems and early death later in life. Some children develop obesity very early, before the age of 5. It is now recognised genes (the biological instructions that make up an individual) can play an important role alongside lifestyle and environment. Certain rare single-gene conditions ("monogenic obesity") can strongly influence a child's weight.
The NHS already offers genetic testing for children with severe early-onset obesity, but it is not known how useful these tests are in everyday clinical practice. This study will help answer that question.
The DECODE study will look back at information already collected from children aged 2-18 who attended specialist Complications of Excess Weight (CEW) clinics in England between 2021 and 2025. These clinics support children with severe obesity and related health problems. The study will include children whose obesity started before age 5 and who have already had one or both NHS genetic tests: the R149 obesity gene panel or a comparative genomic hybridisation (CGH) array (a test that looks for missing or extra pieces of DNA).
The aim is to find out how often these tests detect a genetic cause of obesity ("diagnostic yield") and whether certain clinical features-such as developmental delay, neurodivergence, short stature or different eating behaviours -help predict a positive result.
No new tests or visits are required for this study. Only anonymised information from medical records will be used. Around 500-800 children from up to ten hospitals are expected to be included.
The findings will help the NHS understand who benefits most from genetic testing and how results can guide treatment, support families, and shape future services.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants will be identified from paediatric tier 3 complications of excess weight (CEW) clinic services in England.
Key inclusion criteria (4 listed)
- Aged 2-18 years old
- Early onset of obesity (before 5 years old)
- Obesity (BMI SDS ≥3/ ≥99.6th percentile)
- Attended a Complications of Excess Weight (CEW) clinic appointment between 2021 and 2025 (inclusive) and had a genetic investigation (R149 and/or CGH) array
Key exclusion criteria (3 listed)
- Onset of obesity after 5 years of age
- History of chemotherapy, radiotherapy, antipsychotics and steroid use (possible iatrogenic causes of obesity)
- Known diagnosis of craniopharyngioma or hypothalamic tumour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic yield of R149 and CGH array genetic testing in patients with severe, early-onset obesity under specialist paediatric weight management services
Time frame: 2021-2025
1 secondary outcome
The association of clinical features in the history with a positive genetic diagnosis namely: developmental delay, neurodivergence, learning difficulties, short stature, appetite dysregulation and restricted diet.
Time frame: 2021-2025
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 25 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Georgina Yan.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 25 Mar 2026. 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?
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?
Diagnostic yield of R149 and CGH array genetic testing in patients with severe, early-onset obesity under specialist paediatric weight management services (time frame: 2021-2025). 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 25 Mar 2026.