| CTRI Number |
CTRI/2025/12/098711 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutrition Interventions ] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study to check the impact of Nutrition Interventions on Young Adult Women who are obese. |
|
Scientific Title of Study
|
Efficacy of Nutrition Interventions on Obese Young Adult Women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manpreet Kaur |
| Designation |
Ph.D. Scholar |
| Affiliation |
Kurukshetra University Kurukshetra |
| Address |
Room No. 111 Department of Home Science Kurukshetra University Kurukshetra
Kurukshetra
HARYANA
136119
India |
| Phone |
9812326141 |
| Fax |
|
| Email |
manpretkaur050@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manpreet Kaur |
| Designation |
Ph.D. Scholar |
| Affiliation |
Kurukshetra University Kurukshetra |
| Address |
Room No. 111 Department of Home Science Kurukshetra University Kurukshetra
Kurukshetra
HARYANA
136119
India |
| Phone |
9812326141 |
| Fax |
|
| Email |
manpretkaur050@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Bala |
| Designation |
Assistant Professsor |
| Affiliation |
Kurukshetra University Kurukshetra |
| Address |
Department of Home Science Kurukshetra University Kurukshetra
Kurukshetra
HARYANA
136119
India |
| Phone |
9416468400 |
| Fax |
|
| Email |
suman_81@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| University Grants Commission |
|
|
Primary Sponsor
|
| Name |
UGC NET JRF Scholarship |
| Address |
University Grants Commission (UGC) Bahadur Shah Zafar Marg, New Delhi Pin: 110 002 |
| Type of Sponsor |
Research institution |
|
|
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 Ashish Aneja |
Kurukshetra University |
Room No. 109, Department of Home Science
Kurukshetra
HARYANA |
9813458645
ashishanejadr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee Kurukshetra University Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E66||Overweight and obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Subjects will not be intervened with any kind of intervention for 6 month. |
| Intervention |
Nutri Dense Mixture Supplemented Group |
Subjects will be intervened with developed nutri dense mixture based food product only for 6 month. |
| Intervention |
Nutri Dense Mixture Supplemented Group and Nutrition Education Group |
Subjects will be intervened with both nutri dense mixture based recipe and nutrition education for 6 month. |
| Intervention |
Nutrition Education and Physical Activity Group |
Subjects will be intervened with both nutrition education and physical exercise for 6 month. |
| Intervention |
Nutrition Education Group |
Subjects will be intervened with nutrition education only for 6 month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Unmarried, obese young adult women from colleges or universities who want to voluntary participate in study. |
|
| ExclusionCriteria |
| Details |
Young adult women with a history of or cuurent diagnosis of any significant metabolic or enocrine disorders including Thyroid, PCOS/PCOD,Diabetes Mellitus, eating disorders and who are married or taking weight-altering medications. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the impact of Nutrition interventions on the nutritional status of obese subjects. |
3 Months(during intervention) and 6 Months(at the end of intervention). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure the change in dietary intake and quality. |
Baseline(before intervention), 3 Months(during intervention) and 6 Months(at the end of intervention). |
| To measure the change in Knowledge, attitude and practices (KAP) related to nutrition. |
Baseline(before intervention), 3 Months(during intervention) and 6 Months(at the end of intervention). |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The study aims to select 150 obese young adult women from Kurukshetra and to study the efficacy of various nutrition interventions on the nutritional status of young adult women who are obese. The study will be carried out in three phases- In Phase I (Pre-Intervention), data on socio-demographic profile, anthropometric measurements, dietary intake will be evaluated through standard techniques. Development and standardization of nutri-dense mixture and nutri-dense mixture based recipes will be done & nutrition education material will be developed. In Phase II (Intervention) The experimental group will receive nutrition interventions for 6 months and data will be collected at baseline (before the introduction of nutrition interventions), after 3 months (during the interventions) and 6 months (at the end of interventions). In Phase III (Post-Intervention) The impact of various nutrition interventions on the nutritional status of obese young adult will be assessed |