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WOMANLI ( Women Oriented Multimodal Approach Nurturing Lifestyle Improvement) Intervention for weight loss in serious mental illness: a randomized control trial

Efficacy of WOMANLI ( Women Oriented Multimodal Approach Nurturing Lifestyle Improvement) Intervention for weight loss in serious mental illness: a randomized control trial

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056630
Enrollment
56
Registered
2023-08-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F209- Schizophrenia, unspecified

Interventions

Intervention1: WOMANLI: â?¢ Brief introduction regarding the necessity of a healthy lifestyle and the risks of metabolic syndrome. (5 minutes) â?¢ Assessment of perceived healthy lifestyle and barrier

Sponsors

All India Institute of Medical Sciences Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
?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 syndromeTimepoint: 12 Weeks

Secondary

MeasureTime frame
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 Timepoint: 12 WEEKS

Countries

India

Contacts

Public ContactPurbasha Mitra

AIIMS, Bhubaneswar

purbashamitra95@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026