| CTRI Number |
CTRI/2025/02/080890 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on how high school students feel about their body image and to assess their level of satisfaction |
|
Scientific Title of Study
|
Assessment of body image satisfaction in adolescents |
| 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 Sandesh Kini B |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Faculty room 4, Department of Pediatrics, Kasturba Medical College, Manipal, Udupi District, Karnataka, India.
Udupi
KARNATAKA
576104
India |
| Phone |
9731149519 |
| Fax |
|
| Email |
sandesh.kini@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandesh Kini B |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Faculty room 4, Department of Pediatrics, Kasturba Medical College, Manipal, Udupi District, Karnataka, India.
Udupi
KARNATAKA
576104
India |
| Phone |
9731149519 |
| Fax |
|
| Email |
sandesh.kini@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandesh Kini B |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Faculty room 4, Department of Pediatrics, Kasturba Medical College, Manipal, Udupi District, Karnataka, India.
Udupi
KARNATAKA
576104
India |
| Phone |
9731149519 |
| Fax |
|
| Email |
sandesh.kini@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Dr. Sandesh Kini B, Associate Professor, Faculty room number 4, Department of Pediatrics, Kasturba Medical College, Manipal, Udupi District, Karnataka, India. PIN-576104 |
|
|
Primary Sponsor
|
| Name |
Dr. Sandesh Kini B |
| Address |
Faculty room 4, Department of Pediatrics, Kasturba Medical College, Manipal, Udupi District, Karnataka, India. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandesh Kini B |
Sharada Residential School Udupi |
Class room number 8, Academic block, Sharada Residential School, Kunjibettu, Udupi Town, Udupi District, Karnataka, India. PIN-576101
Udupi
KARNATAKA |
9731149519
sandesh.kini@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College/Kasturba Hospital lnstitutional Ethical Committee (KMC/KH IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents aged 13-16 years who provide assent and have consent from caregivers to participate in the study |
|
| ExclusionCriteria |
| Details |
Adolescents with a history of psychiatric illness or any condition affecting self-perception or unwilling to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Level of body image satisfaction, will be categorized into low/moderate/high satisfaction based on scale cut-off scores. |
Outcome will be assessed at baseline at the start of the study on day 1. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between body image satisfaction & factors like age, gender, socioeconomic status, & social media exposure will be analyzed. |
Outcome will be assessed at baseline on day 1 at the start of the study. |
|
|
Target Sample Size
|
Total Sample Size="229"
Sample Size from India="229"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Aim of the study is to assess the level of body image satisfaction among adolescents in high school. Primary objective of the study is to determine the prevalence of body image satisfaction among high school students and to analyze the association between body image satisfaction and demographic variables such as age, gender, and socioeconomic status. Secondary objective of the study is to identify potential influencing factors, including social media exposure, peer influence, and self-esteem, on body image perception. Consent will be obtained from the school Principal to conduct a cross sectional observational study among high school students aged 13 to 16 years. The study will be commenced after obtaining approval from Kasturba Medical College Manipal Institutional Ethics Committee. A health education talk on “body image issues among adolescents” will be given to the students by the principal investigator before the data collection, following which a structured self-reported questionnaire called the ”Adolescent Body Image Satisfaction Scale (ABISS)” will be provided to each student meeting the inclusion criteria. Demographic and clinical data such as age, gender, parents occupation, diet, sleep, bowel and bladder habits etc will be noted down in the pre-designed proforma. Anthropometric data such as height, weight, waist/hip circumference will be noted. General physical examination and systemic examination will be performed and the findings will be noted down. Students will be categorized as normal BMI/ underweight/ overweight/obese. Based on the ABISS score the students will be categorized as having low/moderate/high body image satisfaction. The data will be compiled in an excel sheet and will be subjected to statistical analysis. Children with low body image satisfaction will be counselled by the principal investigator and will be referred to Kasturba Hospital Manipal for mental health support if indicated. |