Overweight and Obesity and Puberty Development Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-12
SponsorShanghai Jiao Tong University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children over 6 years old from grade 1, 2 and 3 in selected primary schools in Zhongshan, Qufu and Huhhot since 2019
Disqualifiers
Children with overweight or obesity had a history of hormone drug treatment last for 6 months
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Anthropometric measuring
DeviceTo 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.
Growth environment evaluation
Other interventionThe 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.
Treatment groups
14,100 Participants
are divided into 2 treatment groupsGroup A: Overweight and obesity group2 interventions
Group B: Non-overweight group2 interventions
Trial outcomes
Primary outcomes
1
Rate of precocious puberty
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.
Time frame
1 yearSecondary outcomes
1
Rate of early puberty
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.
Time frame
1 yearSponsors and contacts
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Shanghai Jiao Tong University School of Medicine
Lead sponsor
Shanghai Children's Medical Center
Collaborator
BoAi Hospital of Zhongshan
Collaborator
QuFu People's Hospital
Collaborator
Inner Mongolia People's Hospital
Collaborator
Source ClinicalTrials.gov