Childhood ObesityNCT05622513
Phthalate Esters and Childhood Obesity
An observational study of Childhood Obesity, run by Shenzhen Center for Disease Control and Prevention.
Trial summary
Phthalate esters have been considered closely related with childhood obesity, but the existing studies revealed inconsistent results. This study was desigened to investigate the association between phthalate esters and childhood obesity in China. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 4 Nov 2022
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Students aged 6-8 years from monitoring schools in Shenzhen, China.
Who may be able to join
- Children who were classified as normal, overweight and obesity based on age, gender and BMI.
Who cannot join
- The participants who were with endocrine disorders.
About this study
Official title: the Association Between Phthalate Esters and Childhood Obesity
Phthalate esters have been considered closely related with childhood obesity, but the existing studies revealed inconsistent results. This study was desigened to investigate the association between phthalate esters and childhood obesity in China.
Read the detailed description
The physical activity, dietary intake and the levels of urine phthalate metabolites of children were detected, and the associations between these 3 factors and childhood obesity were analyzed.
- Conditions
- Childhood Obesity
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cases | obesity / overweight children | |
| controls | normal weight children |
What is being measured
The primary outcome is the main question the study is designed to answer.
the levels of urine phthalate metabolites
9 phthalate metabolites (MMP, MEP, MnBP, MiBP, MEHP, MEOHP, MEHHP, MCEPP, MCMHP) in first morning urine sample of the participants were detected
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Sep 2016
- Primary completion1 Jun 2017
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Center for Disease Control and Prevention
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Di Li, Shenzhen Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622513
- Sponsor's protocol ID
- szCDC_3
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li D, Yao Y, Chen D, Wu Y, Liao Y, Zhou L. Phthalates, physical activity, and diet, which are the most strongly associated with obesity? A case-control study of Chinese children. Endocrine. 2023 Oct;82(1):69-77. doi: 10.1007/s12020-023-03465-w. Epub 2023 Aug 2.
PubMed 37532921
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Association Between Phthalate Esters and Childhood Obesity
- ClinicalTrials.gov ID
- NCT05622513
- Acronym / sponsor ID
- szCDC_3
- Conditions
- Childhood Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Shenzhen Center for Disease Control and PreventionOther government
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 18 Nov 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.
Phthalate esters have been considered closely related with childhood obesity, but the existing studies revealed inconsistent results. This study was desigened to investigate the association between phthalate esters and childhood obesity in China.
Detailed description
The physical activity, dietary intake and the levels of urine phthalate metabolites of children were detected, and the associations between these 3 factors and childhood obesity were analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | –obesity / overweight children |
| controls | – | –normal weight children |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Students aged 6-8 years from monitoring schools in Shenzhen, China.
Key inclusion criteria (1 listed)
- Children who were classified as normal, overweight and obesity based on age, gender and BMI.
Key exclusion criteria (1 listed)
- The participants who were with endocrine disorders.
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
the levels of urine phthalate metabolites
Time frame: 3 months
9 phthalate metabolites (MMP, MEP, MnBP, MiBP, MEHP, MEOHP, MEHHP, MCEPP, MCMHP) in first morning urine sample of the participants were detected
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 18 Nov 2022.
- Derived from this study: PubMed 37532921Li D, Yao Y, Chen D, Wu Y, Liao Y, Zhou L. Phthalates, physical activity, and diet, which are the most strongly associated with obesity? A case-control study of Chinese children. Endocrine. 2023 Oct;82(1):69-77. doi: 10.1007/s12020-023-03465-w. Epub 2023 Aug 2.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity, run by Shenzhen Center for Disease Control and Prevention.
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: finished, as of the sponsor's last update on 18 Nov 2022. 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?
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?
the levels of urine phthalate metabolites (time frame: 3 months). 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 NCT05622513, which also lists 1 linked publication.
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 18 Nov 2022.