Overweight and Obesity and Puberty Development Cohort Study

February 3, 2020 updated by: Sijia Gu, Shanghai Jiao Tong University School of Medicine

The Effect of Childhood Overweight and Obesity and Genetic Factors on Puberty Development: a Prospective Cohort Study

Precocious puberty and childhood overweight and obesity are important public health problems that both had adverse effects, which including psychological symptom in childhood, short final height or reproductive dysfunction in adulthood, on children's physical and psychological development.The prevalence of precocious puberty and childhood overweight and obesity are both high, and a growing body of epidemiological studies suggested that there was a close relationship of childhood overweight and obesity with puberty development, especially in girls. However, the underlying mechanism between them is unclear. Existing evidence shows that the occurrence of precocious puberty and overweight and obesity are the result of interaction of multiple factors, which consists growth environment and genetics, and many previous studies provided that more overlapping genes existed between obesity and precocious puberty patients, suggesting that common genes may result in these diseases. Therefore, based on a case control study, which will investigate the associations between obesity pleiotropic genes and early puberty, the researchers will collect information related to obesity, growth environment factors and risk genes in this study to evaluate the relationships of these related factors and precocious puberty, and to further explore whether there exists biological interaction effects of these risk factors on sexual precocity. This project has been approved by the Ethics Committee of Shanghai Children's Medical Center.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Purpose: A prospective cohort study. The aim of this study is to investigate the effect of pediatric weight status and childhood growth environment on puberty development.
  2. Participants: Participants are primary school children aged 6- to 12-year-old, and their parents must be willing to engage in this study and comply with study requirements.
  3. Study Procedure: According to geographic and population distribution, about 40 schools included in this study by stratified, random clustering sampling in three cities of China, including Qufu, Zhongshan and Huhhot. Participant will accept anthropometric measuring by clinicians from the three collaborated hospitals, including BoAi Hospital of Zhongshan, QuFu People' s Hospital and Inner Mongolia People's Hospital. This study will be conducted among children of grade 1 to 3 from selected schools in 2019 and the first, secondary and third follow-up will be conducted one, two and three year later respectively.
  4. Exposures: Participants with overweight or obesity will be included in overweight and obesity group at baseline.
  5. Related risk factors: Childhood growth and family environmental information, including physical activity, diet habit, sleep duration, family structure and family social-economic status, will be collected by parent-reported questionnaire;
  6. Outcomes measures: Participants' puberty stage will be evaluated by secondary sexual characteristics development by physician palpation.

Study Type

Observational

Enrollment (Anticipated)

14100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A stratified random sample of children over 6 years old from grade 1 to 3 of selected primary schools in three cities in China

Description

Inclusion Criteria:

  • Children over 6 years old from grade 1, 2 and 3 in selected primary schools in Zhongshan, Qufu and Huhhot since 2019

Exclusion Criteria:

  • Children with overweight or obesity had a history of hormone drug treatment last for 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Overweight and obesity group
  1. Children with BMI cutoff points greater than 25.0 or 30.0 at 18 years old were defined overweight or obesity according to age- and sex-specific cutoff points standard proposed by International Obesity Task Force (IOTF) for 2- to 18-year-old children.
  2. Willingness to comply with study requirements
Device: Anthropometric measuring
To divide participants into overweight and obesity and non-overweight group according to their weight status, height (H), weight (W) and waist circumference (WC) will be measured with a uniform tool, which has been calibrated. When measuring the height, the subjects are required to take off their shoes and stand in an upright position. To measuring weight, the subjects are required to wear close-fitting clothes and bare feet. Subjects are required to take the standing position to measure waist circumference horizontally at the mid-point of line between the lower margin of the ribs and the upper margin of the ilium. All those data will be kept one decimal place. Anthropometric measuring will be taken at baseline and follow-up periods.
Other: Growth environment evaluation
The information of children' growth environment, including family environment, physical activities, dietary and sleep habits, will be collected by parent-report questionnaire at baseline and follow-up periods.
Non-overweight group
  1. Children with BMI smaller than 25.0 at 18 years old were defined non-overweight according to age- and sex-specific cutoff points standard proposed by International Obesity Task Force (IOTF) for 2- to 18-year-old children.
  2. Willingness to comply with study requirements
Device: Anthropometric measuring
To divide participants into overweight and obesity and non-overweight group according to their weight status, height (H), weight (W) and waist circumference (WC) will be measured with a uniform tool, which has been calibrated. When measuring the height, the subjects are required to take off their shoes and stand in an upright position. To measuring weight, the subjects are required to wear close-fitting clothes and bare feet. Subjects are required to take the standing position to measure waist circumference horizontally at the mid-point of line between the lower margin of the ribs and the upper margin of the ilium. All those data will be kept one decimal place. Anthropometric measuring will be taken at baseline and follow-up periods.
Other: Growth environment evaluation
The information of children' growth environment, including family environment, physical activities, dietary and sleep habits, will be collected by parent-report questionnaire at baseline and follow-up periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of precocious puberty
Time Frame: 1 year
All subjects will accept physician palpation to assess their puberty development stage according to Tanner staging method: Testicular volume will be measure by palpation and a Prader testicular meter and be graded to 1 (< 4 ml) to 5 (> 20 ml) in boys. Breast development will be graded to 1(pre-adolescent) to 5 (fully mature) in girls. Pubic hair development will be graded to 1(pre-adolescent) to 5 (fully mature) in both boys and girls. Precocious puberty will be defined as the onset age of breast development (B2) or pubic hair development (PH2) before 8 years or menarche before 10 years in girls and of PH2 or testicular enlargement (T2) before 9 years in boys. For girls with overweight or obesity, breast ultrasound will be used to discriminate glandular breast and fat tissue.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of early puberty
Time Frame: 1 year
All subjects will accept physician palpation to assess their puberty development stage according to Tanner staging method: Testicular volume will be measure by palpation and a Prader testicular meter and be graded to 1 (< 4 ml) to 5 (> 20 ml) in boys. Breast development will be graded to 1(pre-adolescent) to 5 (fully mature) in girls. Pubic hair development will be graded to 1(pre-adolescent) to 5 (fully mature) in both boys and girls. Early puberty will be defined as children reached a certain puberty stage earlier than the median age of that stage. According to a large Chinese population-based study, the median ages for pubertal stages will be referenced. Moreover, the presence of menarche before 12 years in girls and of voice breaking before 13 years in boys will also be categorized as early puberty.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai Children's Medical Center
Inner Mongolia People's Hospital
QuFu People's Hospital
BoAi Hospital of Zhongshan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2019

Primary Completion (Anticipated)

October 1, 2026

Study Completion (Anticipated)

December 30, 2026

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

October 1, 2019

First Posted (Actual)

October 2, 2019

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCMCIRB-K2019007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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