| CTRI Number |
CTRI/2024/12/078185 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Exploring Stress Hormone Levels and Sleep-Wake Cycle Issues in Overweight Teenagers: A Snapshot Study |
|
Scientific Title of Study
|
Cortisol dynamics and chronobiological disruptions in adolescent obesity: A cross-sectional analysis |
| 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 Jayabharathi M |
| Designation |
Postgraduate |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute, SBV (Deemed to be-University) |
| Address |
Department of Community Medicine, 2nd Floor, Mahatma Gandhi Medical College and Research Institute
SBV Pondicherry College Campus
Pillaiyarkuppam
Department of Community Medicine, 2nd Floor, Mahatma Gandhi Medical College and Research Institute
SBV Pondicherry College Campus
Pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9943813809 |
| Fax |
|
| Email |
bharathishree05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J Jenifer Florence Mary |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute, SBV (Deemed to be-University) |
| Address |
Department of Community Medicine, 2nd Floor, Mahatma Gandhi Medical College and Research Institute
SBV Pondicherry College Campus
Pillaiyarkuppam
Department of Community Medicine, 2nd Floor, Mahatma Gandhi Medical College and Research Institute
SBV Pondicherry College Campus
Pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9965540150 |
| Fax |
|
| Email |
drjeniferjohn.0912@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr J Jenifer Florence Mary |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute, SBV (Deemed to be-University) |
| Address |
Department of Community Medicine, 2nd Floor, Mahatma Gandhi Medical College and Research Institute
SBV Pondicherry College Campus
Pillaiyarkuppam
Department of Community Medicine, 2nd Floor, Mahatma Gandhi Medical College and Research Institute
SBV Pondicherry College Campus
Pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9965540150 |
| Fax |
|
| Email |
drjeniferjohn.0912@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tamilnadu Alliance for Development of Community Medicine
HIG-I-21,Third Main Road,Nolambur Phase 1 Mogappair West,Chennai-600037,India |
|
|
Primary Sponsor
|
| Name |
Dr Jayabharathi M |
| Address |
Department of Community Medicine,2nd floor,Mahatma Gandhi Medical College and Research Institute, SBV College Campus, Pillayarkuppam,Pondicherry-607402,India |
| Type of Sponsor |
Other [Self] |
|
|
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 Jayabharathi |
Mahatma Gandhi Medical College and Research Institute |
Department of Community Medicine, 2nd Floor,SBV College Campus, Pillaiyarkuppam, Puducherry to cuddalore main road
607402
Pondicherry
PONDICHERRY |
9943813809
bharathishree05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non obese and Obese individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
High BMI group |
Participants with BMI ≥25 kg/m² are included for assessment of anthropometric and cortisol parameters |
| Comparator Agent |
Normal BMI Group |
Participants with a BMI between 18.5 to 24.9 kg/m² are included for the same assessment. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
BMI ≥25 kg/m2 (As per the Asian guidelines) and waist-hip ratio (WHR) ≥0.8
Body fat percentage of ≥35% (calculated by the formula (1.20 x BMI) + (0.23 x Age) – 5.4)
Undergraduate female students in the age group of 17 to 19 years
|
|
| ExclusionCriteria |
| Details |
Diagnosed obesity due to known endocrine disorders
Participants taking medications that may cause obesity will not be included in the study |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum cortisol levels |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Body mass index, blood pressure, waist-hip ratio and body fat percentage |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2024 |
| Date of Study Completion (India) |
22/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Submitted for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study investigates the relationship between adolescent obesity, serum cortisol dynamics, and chronobiological disruptions. Using a cross-sectional design, it focuses on adolescents aged 17 to 19 years to explore the association between obesity, sleep patterns, and cortisol levels. Anthropometric indices such as BMI and waist-hip ratio will assess obesity, while validated questionnaires will gather data on sleep quality and chronotype. Serum cortisol levels will be measured to evaluate hypothalamic-pituitary-adrenal (HPA) axis activity. Stratified sampling will be employed to recruit college students in Puducherry. The findings aim to elucidate hormonal and lifestyle factors contributing to obesity, supporting the development of targeted public health interventions. |