| CTRI Number |
CTRI/2024/04/065457 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
06/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To motivate Physical Activity among Menopause women to improve Self Efficacy and Quality of Life . |
|
Scientific Title of Study
|
Adherence to Physical Activity through Motivational Interviewing to improve Self Efficacy and Quality of Life among Menopause women |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRIYADHARSHINIG |
| Designation |
PG STUDENT |
| Affiliation |
SRIHER |
| Address |
DEPARTMENT OF MIND BODY MEDICINE AND LIFESTYLE SCIENCES, SRFAHS,SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH ,PORUR,CHENNAI-600116
CHENNAI-600116
TAMIL NADU
INDIA
DEPARTMENT OF MIND BODY MEDICINE AND LIFESTYLE SCIENCES, SRFAHS,SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH ,PORUR,CHENNAI-600116
CHENNAI-600116
TAMIL NADU
INDIA
Chennai
TAMIL NADU
600116
India |
| Phone |
7904772597 |
| Fax |
|
| Email |
a3922005@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DRDCMATHANGI |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
SRIHER |
| Address |
DEPARTMENT OF MIND BODY MEDICINE AND LIFESTYLE SCIENCES, SRFAHS,SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH ,PORUR,CHENNAI-600116
CHENNAI-600116
TAMIL NADU
INDIA
DEPARTMENT OF MIND BODY MEDICINE AND LIFESTYLE SCIENCES, SRFAHS,SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH ,PORUR,CHENNAI-600116
CHENNAI-600116
TAMIL NADU
INDIA
Chennai
TAMIL NADU
600116
India |
| Phone |
9940635874 |
| Fax |
|
| Email |
dcmathangi@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DRDCMATHANGI |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
SRIHER |
| Address |
DEPARTMENT OF MIND BODY MEDICINE AND LIFESTYLE SCIENCES, SRFAHS,SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH ,PORUR,CHENNAI-600116
CHENNAI-600116
TAMIL NADU
INDIA
DEPARTMENT OF MIND BODY MEDICINE AND LIFESTYLE SCIENCES, SRFAHS,SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH ,PORUR,CHENNAI-600116
CHENNAI-600116
TAMIL NADU
INDIA
Chennai
TAMIL NADU
600116
India |
| Phone |
9940635874 |
| Fax |
|
| Email |
dcmathangi@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,PORUR,CHENNAI-600116 |
|
|
Primary Sponsor
|
| Name |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, PORUR,CHENNAI-600116 |
| 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 |
| Priyadharshini G |
Sri Ramachandra Institute of Higher Education and Research |
Department of Mind Body Medicine and Lifestyle Sciences, Sri Ramachandra Faculty of Allied Health Sciences, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai -600116.
Chennai-600116
Tamil Nadu
India
Chennai
TAMIL NADU |
7904772597
a3922005@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Individual with PCOS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Motivation Interviewing |
The study participants would be randomly assigned to the motivational group and will receive Motivational Interviewing once a session per week (4 week). First session in person and next three sessions will be done over phone. |
| Comparator Agent |
Physical Activity |
Pre assessment would be performed in the consenting participants of the study .participants would be asked to go for walking (Physical Activity) for a minimum of 30-40 min/day/4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Individuals who have attained menopause and are less than 60.00 years old.
Individuals who have the comorbidity of hyperthyroidism/hypothyroidism and T2DM. |
|
| ExclusionCriteria |
| Details |
Individual who had injuries/deformities/undergone any surgery in the recent days.
Individuals who are more than 60.00 years old. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Behaviour change |
Adherence to physical activity through Motivational Interviewing (intervention group) or no intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
18/04/2024 |
| 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="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
|
Motivational interviewing can enhance adherence to physical activity during menopause by addressing barriers, boosting self efficacy, and emphasising the positive impact on quality of life. Regular physical activity can mitigate menopausal symptoms, reduce vasomotor symptoms, improves mood and overall well-being.The study outcome will be publish once all data are collected and analysed. |