| CTRI Number |
CTRI/2023/08/056630 [Registered on: 18/08/2023] Trial Registered Prospectively |
| Last Modified On: |
17/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
WOMANLI ( Women Oriented Multimodal Approach Nurturing Lifestyle Improvement) Intervention for weight loss in serious mental illness: a randomized control trial |
|
Scientific Title of Study
|
Efficacy of WOMANLI ( Women Oriented Multimodal Approach Nurturing Lifestyle Improvement) Intervention for weight loss in serious mental illness: a randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Purbasha Mitra |
| Designation |
Junior Resident, Department of Psychiatry |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Room no 123, Department of
Psychiatry, Aiims bhubaneswar, Sijua, Patrapada, Khordha
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
purbashamitra95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Purbasha Mitra |
| Designation |
Junior Resident, Department of Psychiatry |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Room no 124, Department of Psychiatry, Aiims Bhubaneswar, Sijua, Patrapada, Khordha
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
purbashamitra95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Purbasha Mitra |
| Designation |
Junior Resident, Department of Psychiatry |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Room no 123, Department of Psychiatry, Aiims Bhubaneswar, Sijua, Patrapada, Khordha
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
purbashamitra95@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
SIJUA, PATRAPADA, KHordha |
| Type of Sponsor |
Government 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 Shree Mishra |
All India Institute of Medical Sciences Bhubaneswar, |
Psychiatry OPD room 124 and D2 ward Sijua, Patrapada, Khordha
Khordha
ORISSA |
8249255952
psych_shree@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMSBHubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F209||Schizophrenia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Comparator Agent |
no name |
Scales and questionnaires will be applied. participants will be briefly advised about healthy lifestyle over 5 minutes |
| Comparator Agent |
no name |
Scales and questionnaires will be applied. participants will be briefly advised about healthy lifestyle over 5 minutes |
| Comparator Agent |
no name |
Scales and questionnaires will be applied. participants will be briefly advised about healthy lifestyle over 5 minutes |
| Intervention |
WOMANLI |
• Brief introduction regarding the necessity of a healthy lifestyle and the risks of metabolic syndrome. (5 minutes)
• Assessment of perceived healthy lifestyle and barriers and facilitators for implementing positive lifestyle practices for patients and caregivers (10 minutes)
• Information about the Healthy eating options available in Odisha from “ Byanjan†a book by Government Of Odisha(10 minutes)
• Discussion and demonstration of proposed exercise module: Based on a home based, life style integrated exercise training programme by Cegieski et al(31), but modified according to Indian settings and Yogasanas: (20 minutes)
 3 sets of 12 repetitions of each exercise at least 4 days a week(will be demonstrated as video module)
 Squats(Dand baithak)
 Calf raise
 Biceps curls
 Triceps extension
 Press up
 Oblique twists
 10 to 30 minutes of brisk walking/ running (modifiable according to settings)
 Yogasanas (modifiable according to patient preference and feasibility)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Women clinically diagnosed with Schizophrenia spectrum Disorders or BPAD or Depression as per DSM 5 within at least 4 months who are clinically stable on a stable dose of at least one atypical antipsychotic for more than 3 months/2 months .
2. Patients with fulfilling at least 3 criteria of NCEP ATP III guidelines
3. Patients of 18 to 65 years
4. Legally authorized representative (LAR) /patient giving voluntary written consent for participation in the study
|
|
| ExclusionCriteria |
| Details |
1. Patients with Severe illness with active psychotic symptoms
2. Patients with significant head trauma or organic disease
3. Physical disability affecting mobilization
4. Pregnant and lactating mothers
• Patients unable to communicate
• Male patients
Any contraindications for physical exercise
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| â— To compare the effect of Intervention versus TAU on the lifestyle of the participants to be measured by change in weight over a period of 24 weeks in female patients with serious mental illness as per DSM 5 for at least 6 months and on atypical antipsychotics for at least 3 months fulfilling NCEP ATP III criteria for metabolic syndrome |
12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the effectiveness of this Intervention in terms of changes in the other physical and biochemical parameters of metabolic syndrome :
Lipid profile as measured by Triglyceride and Total Cholesterol
Fasting blood sugar
Blood Pressure
Waist and hip circumference
Body Mass Index
2. To compare the effectiveness of Intervention in terms of lifestyle implementation with help of following tools:
GPAQ( Score to be converted to mets per minute)
3. To compare the effectiveness of Intervention in terms of changes in mental health outcomes measured by :
BPRS, PANSS, YMRS, HDRS, GAF
4. Explore the facilitators and barriers in implementing the intervention by the care givers and the subjects in a semistructed questionnaire
|
12 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/08/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study is proposed
to be a randomized control trial which
will be conducted over a timeframe of 12 weeks.
The women diagnosed with SMI on a stable dose of 2nd generation
antipsychotics for at least 3 months attending the psychiatry OPD or receiving
IP care will be screened using the NCEP ATP III Definition and 56 amongst them, who are diagnosed as metabolic
syndrome will be recruited for the study. It will be conducted in the Department of Psychiatry,
AIIMS, Bhubaneswar, over a period of 11 months. Written informed consent will
be taken from the legally authorized representative (LAR) after explaining the
objectives and procedure of the study in detail. The detailed history, relevant
socio-demographic details, clinical and treatment data will be collected in a
structured case record form. At baseline Weight, height, waist and hip circumference,
BP will be measured and BMI calculated, FBS, and Fasting Lipid Profile will be tested. BPRS, HDRS, YMRS, PANSS and
GAF will be administered to assess baseline severity of illness. GPAQ will be applied. The study
sample will be randomized using computer-generated random numbers with a 1:1
allocation ratio into two treatment groups, each group comprising of 28 patients.28 Patients who are randomised into the control arm will receive “ Treatment as usual and 28 Patients
who are randomized into the intervention arm, will be given the "WOMANLI" intervention that includes In Person meeting and telephonic intervention. Both groups will be followed up after 12 weeks and primary and secondary outcomes will be measured |