Efficacy of WOMANLI ( Women Oriented Multimodal Approach Nurturing Lifestyle Improvement) Intervention for weight loss in serious mental illness: a randomized control trial
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
The study is proposedto be a randomized control trial whichwill be conducted over a timeframe of 12 weeks.The women diagnosed with SMI on a stable dose of 2nd generationantipsychotics for at least 3 months attending the psychiatry OPD or receivingIP care will be screened using the NCEP ATP III Definition and 56 amongst them, who are diagnosed as metabolicsyndrome 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 willbe taken from the legally authorized representative (LAR) after explaining theobjectives and procedure of the study in detail. The detailed history, relevantsocio-demographic details, clinical and treatment data will be collected in astructured 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 andGAF will be administered to assess baseline severity of illness. GPAQ will be applied. The studysample will be randomized using computer-generated random numbers with a 1:1allocation 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 Patientswho 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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
时间窗: 12 Weeks
次要结局
- 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)