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NCT Number: NCT04113070

Overweight and Obesity and Puberty Development 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.

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Key information

Conditions

Precocious Puberty Body Weight Endocrine System Diseases Gonadal Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Puberty, Precocious Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location status: Recruiting

Location contact

Shijian Liu, Ph.D

CONTACT

[email protected]

21-38625637

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anthropometric measuring

Device

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.

Growth environment evaluation

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shijian Liu, Ph.D

CONTACT

[email protected]

21-38625637

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2019
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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