Overweight and Obesity and Puberty Development Cohort Study
NCT ID: NCT04113070
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
14100 participants
OBSERVATIONAL
2019-10-11
2026-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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.
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
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Years
12 Years
ALL
No
Sponsors
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Shanghai Children's Medical Center
OTHER
BoAi Hospital of Zhongshan
OTHER
QuFu People's Hospital
INDIV
Inner Mongolia People's Hospital
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Sijia Gu
staff of Research Department
Principal Investigators
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Shijian Liu, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Children's Medical Center
Locations
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Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Chen C, Zhang Y, Sun W, Chen Y, Jiang Y, Song Y, Lin Q, Zhu L, Zhu Q, Wang X, Liu S, Jiang F. Investigating the relationship between precocious puberty and obesity: a cross-sectional study in Shanghai, China. BMJ Open. 2017 Apr 11;7(4):e014004. doi: 10.1136/bmjopen-2016-014004.
Colmenares A, Gunczler P, Lanes R. Higher prevalence of obesity and overweight without an adverse metabolic profile in girls with central precocious puberty compared to girls with early puberty, regardless of GnRH analogue treatment. Int J Pediatr Endocrinol. 2014;2014(1):5. doi: 10.1186/1687-9856-2014-5. Epub 2014 Apr 17.
Wang M, Zhang Y, Lan D, Hill JW. The Efficacy of GnRHa Alone or in Combination with rhGH for the Treatment of Chinese Children with Central Precocious Puberty. Sci Rep. 2016 Apr 13;6:24259. doi: 10.1038/srep24259.
Luke B. Adverse effects of female obesity and interaction with race on reproductive potential. Fertil Steril. 2017 Apr;107(4):868-877. doi: 10.1016/j.fertnstert.2017.02.114.
Deng F, Tao FB, Liu DY, Xu YY, Hao JH, Sun Y, Su PY. Effects of growth environments and two environmental endocrine disruptors on children with idiopathic precocious puberty. Eur J Endocrinol. 2012 May;166(5):803-9. doi: 10.1530/EJE-11-0876. Epub 2012 Feb 8.
Boyne MS, Thame M, Osmond C, Fraser RA, Gabay L, Reid M, Forrester TE. Growth, body composition, and the onset of puberty: longitudinal observations in Afro-Caribbean children. J Clin Endocrinol Metab. 2010 Jul;95(7):3194-200. doi: 10.1210/jc.2010-0080. Epub 2010 Apr 28.
Biro FM, Khoury P, Morrison JA. Influence of obesity on timing of puberty. Int J Androl. 2006 Feb;29(1):272-7; discussion 286-90. doi: 10.1111/j.1365-2605.2005.00602.x. Epub 2005 Dec 20.
Kaplowitz PB. Link between body fat and the timing of puberty. Pediatrics. 2008 Feb;121 Suppl 3:S208-17. doi: 10.1542/peds.2007-1813F.
Abdel Ghany SM, Sayed AA, El-Deek SEM, ElBadre HM, Dahpy MA, Saleh MA, Sharaf El-Deen H, Mustafa MH. Obesity risk prediction among women of Upper Egypt: The impact of serum vaspin and vaspin rs2236242 gene polymorphism. Gene. 2017 Aug 30;626:140-148. doi: 10.1016/j.gene.2017.05.007. Epub 2017 May 4.
Grarup N, Moltke I, Andersen MK, Dalby M, Vitting-Seerup K, Kern T, Mahendran Y, Jorsboe E, Larsen CVL, Dahl-Petersen IK, Gilly A, Suveges D, Dedoussis G, Zeggini E, Pedersen O, Andersson R, Bjerregaard P, Jorgensen ME, Albrechtsen A, Hansen T. Loss-of-function variants in ADCY3 increase risk of obesity and type 2 diabetes. Nat Genet. 2018 Feb;50(2):172-174. doi: 10.1038/s41588-017-0022-7. Epub 2018 Jan 8.
Wasim M, Awan FR, Najam SS, Khan AR, Khan HN. Role of Leptin Deficiency, Inefficiency, and Leptin Receptors in Obesity. Biochem Genet. 2016 Oct;54(5):565-72. doi: 10.1007/s10528-016-9751-z. Epub 2016 Jun 16.
Euling SY, Selevan SG, Pescovitz OH, Skakkebaek NE. Role of environmental factors in the timing of puberty. Pediatrics. 2008 Feb;121 Suppl 3:S167-71. doi: 10.1542/peds.2007-1813C.
Marshall WA, Tanner JM. Variations in pattern of pubertal changes in girls. Arch Dis Child. 1969 Jun;44(235):291-303. doi: 10.1136/adc.44.235.291. No abstract available.
Marshall WA, Tanner JM. Variations in the pattern of pubertal changes in boys. Arch Dis Child. 1970 Feb;45(239):13-23. doi: 10.1136/adc.45.239.13.
Bridges NA, Christopher JA, Hindmarsh PC, Brook CG. Sexual precocity: sex incidence and aetiology. Arch Dis Child. 1994 Feb;70(2):116-8. doi: 10.1136/adc.70.2.116.
Lebrethon MC, Bourguignon JP. Management of central isosexual precocity: diagnosis, treatment, outcome. Curr Opin Pediatr. 2000 Aug;12(4):394-9. doi: 10.1097/00008480-200008000-00020.
Klein KO. Precocious puberty: who has it? Who should be treated? J Clin Endocrinol Metab. 1999 Feb;84(2):411-4. doi: 10.1210/jcem.84.2.5533. No abstract available.
Sun Y, Tao FB, Su PY, Mai JC, Shi HJ, Han YT, Wang H, Lou XM, Han J, Liu J. National estimates of the pubertal milestones among urban and rural Chinese girls. J Adolesc Health. 2012 Sep;51(3):279-84. doi: 10.1016/j.jadohealth.2011.12.019. Epub 2012 Mar 15.
Sun Y, Tao F, Su PY; China Puberty Research Collaboration. National estimates of pubertal milestones among urban and rural Chinese boys. Ann Hum Biol. 2012 Nov-Dec;39(6):461-7. doi: 10.3109/03014460.2012.712156. Epub 2012 Aug 6.
Ong KK, Bann D, Wills AK, Ward K, Adams JE, Hardy R, Kuh D; National Survey of Health and Development Scientific and Data Collection Team. Timing of voice breaking in males associated with growth and weight gain across the life course. J Clin Endocrinol Metab. 2012 Aug;97(8):2844-52. doi: 10.1210/jc.2011-3445. Epub 2012 May 31.
Yu T, Yu Y, Li X, Xue P, Yu X, Chen Y, Kong H, Lin C, Wang X, Mei H, Wang D, Liu S. Effects of childhood obesity and related genetic factors on precocious puberty: protocol for a multi-center prospective cohort study. BMC Pediatr. 2022 May 27;22(1):310. doi: 10.1186/s12887-022-03350-x.
Other Identifiers
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SCMCIRB-K2019007
Identifier Type: -
Identifier Source: org_study_id
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