| CTRI Number |
CTRI/2025/10/096221 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating how nutritional education effects the knowledge and practices in perimenopausal women who attend hospital in North Karnataka. |
|
Scientific Title of Study
|
Effect of nutritional education on knowledge and practice among perimenopausal women attending tertiary care centre in North Karnataka. A Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shravana Shivanandayya kalmath |
| Designation |
PG student |
| Affiliation |
School of Allied Health Sciences KAHER Belagavi |
| Address |
Department of Nutrition and Dietetics School of Allied Health Sciences KAHER Belagavi
Department of Nutrition and Dietetics Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
07019008828 |
| Fax |
|
| Email |
shravanakalmath30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hema Patil |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College Belagavi Karnataka |
| Address |
Department of Obstetrics and Gynecology Jawaharlal Nehru Medical College Belagavi Jawaharlal Nehru Medical College Belagavi Karnataka
Nehru nagar Jawaharlal Nehru Medical College Belagavi Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9164342888 |
| Fax |
|
| Email |
hemabanad@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shravana Shivanandayya kalmath |
| Designation |
PG student |
| Affiliation |
School of Allied Health Sciences KAHER Belagavi |
| Address |
Department of Nutrition and Dietetics School of Allied Health Sciences KAHER Belagavi
Nehru nagar School of Allied Health Sciences KAHER Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7019008828 |
| Fax |
|
| Email |
shravanakalmath30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of obstetrics and gynaecology Dr Prabhakar Kore Hospital and Medical Research Centre Belagavi Karnataka |
|
|
Primary Sponsor
|
| Name |
Shravana Shivanandayya Kalmath |
| Address |
Department of Nutrition and Dietetics School of Allied Health Sciences KAHER Belagavi |
| 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 |
| Shravana Kalmath |
KLEs Dr Prabhakar Kore Hospital and Medical College Belagavi |
Nehru Nagar Belagavi Karnataka
Belgaum
KARNATAKA |
7019008828
shravanakalmath30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional ethics committee Jawaharlal Nehru Medical college Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Perimenopausal healthy women. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Nutritional education on knowledge and practice among perimenopausal women. |
Nutritional handouts on perimenopause will be provided for the women who are in intervention group for one week. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women who can communicate normally.
And are aged between 40-45 years.
Who provide consent are included. |
|
| ExclusionCriteria |
| Details |
Women who do not provide consent are excluded.
Women with comorbidities are excluded.
Who are undergoing Hormonal replacement therapy are also excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge scores, practice scores at three points. |
Before giving intervention, immediately after the intervention and at 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be improved knowledge & practice score among perimenopausal women who were in intervention group. |
Before giving intervention, immediately after the intervention & at 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
Final Enrollment numbers achieved (Total)= "132"
Final Enrollment numbers achieved (India)="132" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/11/2025 |
| Date of Study Completion (India) |
20/01/2026 |
| 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)
Modification(s)
|
Completed |
| 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
Modification(s)
|
Perimenopausal women attending the tertiary care center were screened to check whether they can be included in the study or not, and then randomization was done to make control and intervention groups. Then the data was collected at three points from the intervention group and at two points from the control group. And then data was analysed to obtain results. |