| CTRI Number |
CTRI/2024/06/069623 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation between role of Obesity in pubertal growth and early menarche among school going female children in Madurai district. |
|
Scientific Title of Study
|
Association of Obesity in pubertal growth and early menarche among school going female children in Madurai district-A Cross sectional study. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Sabana yasmine |
| Designation |
PG SCHOLAR |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16/17,Department of Kuzhandhai Maruthuvam ,National Institute of Siddha,Tambaram Sanatorium,Chennai-47
Kancheepuram TAMIL NADU 600047 India |
| Phone |
9600876457 |
| Fax |
|
| Email |
sabanayasmine2020@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K Suresh |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16/17,Department of Kuzhandhai Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,chennai-47
Kancheepuram TAMIL NADU 600047 India |
| Phone |
9962571137 |
| Fax |
|
| Email |
drsureshherbal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr K Suresh |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16/17,Department of Kuzhandhai Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,chennai-47
Kancheepuram TAMIL NADU 600047 India |
| Phone |
9962571137 |
| Fax |
|
| Email |
drsureshherbal@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,Tambaram Sanatorium,Chennai-47 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room no 16/17,Department of Kuzhandhai Maruthuvam,National Institute of Siddha , Tambaram Sanatorium, Chennai-47
Kancheepuram. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr N Sabana yasmine |
Schools in Madurai District |
MADURAI DISTRICT
Zone 1- one of the Primary and secondary schools in Goripalayam.
Zone 2- one of the primary and secondary schools in tallakulam.
Zone 3- one of the primary and secondary schools in uthangudi.
Zone 4- one of the primary and secondary schools in theppakulam. Madurai TAMIL NADU |
9600876457
sabanayasmine2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| District Educational Officer, Madurai district . |
Approved |
| Institutional Ethics Committee, National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
obesity and Early menarche |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Female |
| Details |
1.Girls of age group 8years to 12 years
2.School going girls attained menarche |
|
| ExclusionCriteria |
| Details |
1.Presence of any associated severe systematic illness.
2.Presence of pelvic pathology such as chronic pelvic infection,pelvic endometriosis.
3.Actively taken any medication for other health problems. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The relation between the association of obesity in pubertal growth and early menarche among school going female children in Madurai district will be reported |
Getting approval from screening IEC at NIS -1 months
Study commencement and conduct of the study – 4 months
Data compilation and analysis of data – 15 days
Submission of report and publication – 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="184" Sample Size from India="184"
Final Enrollment numbers achieved (Total)= "184"
Final Enrollment numbers achieved (India)="184" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
BACKGROUND : Obesity is a major public health problem that has grown to epidemic proportions throughout the world. Rates in adults range from 10 to 25% in most Western European countries and from 20 to 25% in some parts of the United States. In children and adolescents, the National Health and Nutrition Examination Survey (NHANES III) reported an estimated 20% prevalence of obesity, defined as a body mass index (BMI) greater than 85th percentile. For all age groups and degrees of obesity ,girls are higher risk than boys. Obesity is not restricted to a single ethic, age, or socioeconomic group, although cultural, environmental, and genetic factors clearly play a role. The environmental factors that contribute to the development of a high degree of body fatness early in life include a high proportion of sedentary activities (eg, TV viewing), low proportion of physical activity, and a shift in diet towards more fast foods with high fat and calorie content. Among the genetic factors, polymorphism or mutations in any of the following genes may be involved in the pathophysiology of obesity Leptin is a protein product of the obesity (ob) gene. It is secreted as a hormone mainly from white adipose tissue and serves as a signal for the brain of the body’s energy stores .By reducing food intake and increasing thermogenesis, leptin controls body fat tissue and, hence, body weight. Studies of its physiologic action in humans have shown a strong positive correlation between serum leptin concentrations and the percentage of body fat. Severe obesity is associated with a higher likelihood of continued overweight. This risk is much higher in children with obese parents. Studies have shown that parental obesity is the most important risk factor of obesity in children, owing to both the genetic influence and the shared environment (lifestyle, nutritional habits, food preferences, etc). Several critical periods in childhood have been identified in the development and persistence of obesity. In the gestational period, there is a direct association of high birth weight with subsequent adiposity. Thereafter, in the first year of life, children undergo changes in nutritional behavior which may influence adiposity in later life. Another crucial period is ages of 5-8 years, where adiposity increases after its nadir in childhood (‘adiposity rebound’). An early adiposity rebound may serve an index of further obesity. The final risk period for the development of persistent obesity is adolescence. The observation that overweight girls tend to mature earlier than lean girls has led to the hypothesis that the degree of body fatness may trigger the neuroendocrine events that lead to the onset of menses .obesity, as measured by BMI, A correlation was also found between age at adiposity rebound and age at menarche, As obese children have higher leptin levels than lean children, this may be an important factor in their earlier onset of puberty OBJECTIVE : To determine the association of obesity in pubertal growth and early menarche among school going female children in Madurai district. STUDY DESIGN: This is an Cross Sectional Study of Randomized Sampling method will be held for 6 months on Association of obesity in pubertal growth and early menarche among school going female children in Madurai district with 184 participants and her parent and to whom a questionnaire regarding the study and obtaining proper consent form, assent form from the parent. participants who have Presence of any associated severe systematic illness ,Presence of pelvic pathology such as chronic pelvic infection, pelvic endometriosis, Actively taken any medications for other health problems will be excluded from the study. OUTCOME: The Relation between the association of obesity in pubertal growth and early menarche among school going children in Madurai District will be reported. RESULTS AND DISCUSSION: The results will be statistically analysed and reported. KEYWORDS: Obesity, Early Menarche. |