NCT05622513

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2022

Completed
Last Updated

November 18, 2022

Status Verified

November 1, 2022

Enrollment Period

9 months

First QC Date

November 13, 2022

Last Update Submit

November 13, 2022

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Study Arms (2)

cases

obesity / overweight children

controls

normal weight children

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Students aged 6-8 years from monitoring schools in Shenzhen, China.

You may qualify if:

  • Children who were classified as normal, overweight and obesity based on age, gender and BMI.

You may not qualify if:

  • The participants who were with endocrine disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 37532921DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine sample

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

November 13, 2022

First Posted

November 18, 2022

Study Start

September 1, 2016

Primary Completion

June 1, 2017

Study Completion

November 4, 2022

Last Updated

November 18, 2022

Record last verified: 2022-11