| CTRI Number |
CTRI/2026/01/101532 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Structured lifestyle framework consisting of diet, physical activity and sleep] |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate personality-based lifestyle intervention in PCOS |
|
Scientific Title of Study
|
Effectiveness of a Personality-Matched Lifestyle Intervention in Women with Polycystic Ovary Syndrome: A Quasi-Experimental Study |
| 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 B Dharani |
| Designation |
Assistant Professor |
| Affiliation |
ACS Medical College and Hospital |
| Address |
Department of Physiology,
ACS Medical College and Hospital,
Velappanchavadi,
Chennai – 600077, Tamil Nadu, India
Chennai
TAMIL NADU
600077
India |
| Phone |
08610263796 |
| Fax |
|
| Email |
dharani.physio@acsmch.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Dharani |
| Designation |
Assistant Professor |
| Affiliation |
ACS Medical College and Hospital |
| Address |
Department of Physiology,
ACS Medical College and Hospital,
Velappanchavadi,
Chennai – 600077, Tamil Nadu, India
TAMIL NADU
600077
India |
| Phone |
08610263796 |
| Fax |
|
| Email |
dharani.physio@acsmch.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Dharani |
| Designation |
Assistant Professor |
| Affiliation |
ACS Medical College and Hospital |
| Address |
Department of Physiology,
ACS Medical College and Hospital,
Velappanchavadi,
Chennai – 600077, Tamil Nadu, India
TAMIL NADU
600077
India |
| Phone |
08610263796 |
| Fax |
|
| Email |
dharani.physio@acsmch.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ACS Medical College and Hospital |
| Address |
ACS Medical College and Hospital,
Velappanchavadi,
Chennai – 600077,
Tamil Nadu, India |
| Type of Sponsor |
Private medical college |
|
|
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 B Dharani |
ACS Medical College and Hospital |
Department of Physiology,
ACS Medical College and Hospital,
Velappanchavadi,
Chennai – 600077, Tamil Nadu, India
Chennai
TAMIL NADU |
08610263796
dharani.physio@acsmch.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACS MedicalCollege andHospitalInstitutionalEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Structured lifestyle modification |
Structured lifestyle modification framework consisting of structured diet, physical activity and behavioural strategies for duration of 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 18–35 years
Diagnosed with PCOS based on Rotterdam criteria
Not currently pregnant or planning pregnancy during the study period
On stable or no pharmacological treatment for PCOS
Owns a smartphone and has access to WhatsApp or similar digital tools
Willing to participate in a lifestyle intervention and adhere to study protocols |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in body composition parameters (Body Mass Index and body fat percentage) from baseline to 12 weeks following a personality-matched lifestyle intervention in women with Polycystic Ovary Syndrome (PCOS). |
Baseline, at 6 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in anthropometric parameters from baseline to 12 weeks.
Change in body composition parameters from baseline to 12 weeks.
Change in autonomic function from baseline to 12 weeks.
Change in psychological well-being from baseline to 6 weeks and 12 weeks.
Adherence to the personality-matched lifestyle intervention during the 12-week study period.
Feasibility and acceptability of the lifestyle intervention assessed at 12 weeks. |
Baseline, at 6 weeks and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/01/2026 |
| 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="1"
Months="0"
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
|
This quasi-experimental study aims to evaluate the effectiveness of a personality-matched lifestyle intervention in women aged 18–35 years with Polycystic Ovary Syndrome. Over a 12-week intervention period, participants will receive individualized physical activity and lifestyle recommendations tailored to their personality traits, supported by digital adherence strategies. The study will assess changes in body composition, autonomic function, and psychological well-being from baseline to the end of the intervention. The feasibility, acceptability, and adherence to the personalized intervention will also be evaluated. Findings are expected to support a scalable, low-cost, and patient-centered lifestyle management approach for women with PCOS. |