Overweight and Obesity and Puberty Development Cohort Study

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT04113070

Collaborator

Shanghai Children's Medical Center (Other), BoAi Hospital of Zhongshan (Other), QuFu People's Hospital (Other), Inner Mongolia People's Hospital (Other)

14,100

Enrollment

Location

86.6

Anticipated Duration (Months)

162.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Precocious Puberty Overweight and Obesity	Device: Anthropometric measuring Other: Growth environment evaluation

Detailed Description

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.
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.
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.
Exposures: Participants with overweight or obesity will be included in overweight and obesity group at baseline.
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;
Outcomes measures: Participants' puberty stage will be evaluated by secondary sexual characteristics development by physician palpation.

Study Design

Study Type:

Observational

Anticipated Enrollment :

14100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 11, 2019

Anticipated Primary Completion Date :

Oct 1, 2026

Anticipated Study Completion Date :

Dec 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Overweight and obesity group 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. 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 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. 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.

Arm

Intervention/Treatment

Overweight and obesity group

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. 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

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. Willingness to comply with study requirements

Device: Anthropometric measuring

Other: Growth environment evaluation

Outcome Measures

Primary Outcome Measures

Rate of precocious puberty [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.

Secondary Outcome Measures

Rate of early puberty [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine
Shanghai Children's Medical Center
BoAi Hospital of Zhongshan
QuFu People's Hospital
Inner Mongolia People's Hospital

Investigators

Principal Investigator: Shijian Liu, Ph.D, Shanghai Children's Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Sijia Gu, staff of Research Department, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT04113070

Other Study ID Numbers:

SCMCIRB-K2019007

First Posted:

Oct 2, 2019

Last Update Posted:

Feb 5, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sijia Gu, staff of Research Department, Shanghai Jiao Tong University School of Medicine

Additional relevant MeSH terms:

Obesity

Puberty, Precocious

Overweight

Study Results

No Results Posted as of Feb 5, 2020