| CTRI Number |
CTRI/2025/07/090991 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
13/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Screening |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the effectiveness of Meditation therapy in eating disorder among adolescents. |
|
Scientific Title of Study
|
A quasi-experimental study to assess the effectiveness of Structured meditation therapy in eating disorder among adolescents in a selected rural community of Moradabad.
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saba Hashmi |
| Designation |
Phd Scholar |
| Affiliation |
University grants commission |
| Address |
College of Nursing,Teerthanker Mahaveer University, PhD class room
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
09350210423 |
| Fax |
|
| Email |
saba.scholar@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sapna |
| Designation |
Professor |
| Affiliation |
University grant commission |
| Address |
College of Nursing, Teerthanker Mahaveer University, Ground floor office
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9877550108 |
| Fax |
|
| Email |
drsapna.nursing@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sapna |
| Designation |
Professor |
| Affiliation |
university grants commission |
| Address |
College of Nursing, Teerthanker Mahaveer University
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9877550108 |
| Fax |
|
| Email |
drsapna.nursing@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
| Ms.Saba Hashmi Room No.7rufaida College of Nursing Jamia Hamdard New Delhi-110062 India |
|
|
Primary Sponsor
|
| Name |
Saba hashmi |
| Address |
College of Nursing Teerthanker Mahaveer University, Moradabad, Uttar Pradesh, 244001 India |
| Type of Sponsor |
Other [self-fund] |
|
|
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 Saurabh |
Kundarki Block |
Community Health center, ground Floor, Room No.2
Moradabad
UTTAR PRADESH |
08178317194
mbd.phckundarki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teerthanker Mahaveer Unversity Institutional Ethics commeetee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescents with eating disorders |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Méditation therapy |
A méditation therapy will be given to adolescent in the duration of1week 7 week and 6 month. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
The adolescents present at the time of study
Adolescents who know the Hindi or English language
Adolescents willing to participate |
|
| ExclusionCriteria |
| Details |
Not Present at the time if study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of Meditation therapy on eating disorders |
3 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Screening of Eating disorders among adolescents |
5 year |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
01/08/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Adolescence as the period in human growth and development that occurs after childhood and before adulthood from the age of 10-19”. In this vulnerable population prevalence of eating disorder has increased significantly. Eating disorders refers to a group of conditions defined by abnormal eating habits that may involve either insufficient or excessive food intake to the determent of an individual’s physical and mental health. Bulimia nervosa, anorexia nervosa and binge eating disorders are the most common eating disorders, so the objective of that study To assess the prevalence of eating disorders among adolescents in a selected rural community and Second objective is to find out the effect of meditation therapy on eating disorder among adolescents in a selected community. As meditation has a great role in minimizing the eating related disorders. the study will be done in a rural community and after find out the prevalence rate of eating disorders( by administering tools) among adolescents the meditation therapy will be implemented on weekly bass till 6 month to the adolescents who will be having eating disorders .After the intervention post test will be conducted to find out the result. |