Lifestyle Wellness Program (LWP) is a 12-week weight management intervention developed by Eli Lilly Laboratories for controlling weight gain for individuals with schizophrenia under antipsychotic use . The program consists of a one-hour weekly session to discuss topics like dietary choices, lifestyle, physical activity and self-esteem with patients and their relatives . The program combines behavioural techniques such as the use of diaries and role play to dealing with stress, and psychoeducation components including awareness of dietary habits. The intervention is comprised by 12 sessions as follows: a) one session for the introduction of the intervention; b) four sessions for discussing dietary choices using the concept of the food pyramid; c) three sessions for discussing the importance of physical activity; d) one session for self-esteem and motivation; e) one session for management of anxiety; and f) one session opened to relatives, and h) the wrap up of the program . The inclusion of relatives may be a particular feature of the program for countries where most of the patients live with their families as is the case in Brazil. The groups are led by mental health professionals (nurses, occupational therapists, psychologists and dietitians), who are trained with a manual and a set of DVDs explaining the program.
A multicentric randomized clinical trial was conducted to compare the efficacy of this Lifestyle Wellness Program (LWP) with controls on a standard care (SC) group. Patients on the intervention group and on standard care group had regular visits to the psychiatrist and attended regular sessions of other psychosocial interventions offered by the program they were enrolled. Participants were drawn from the following outpatient programs: a) the Schizophrenia Program (Programa de Esquizofrenia – PROESQ, Universidade Federal de São Paulo); b) the Schizophrenia Program of Institute of Psychiatry- PROJESQ (Universidade de São Paulo); c) the CAISM (Centro de Atenção Integrada à Saúde Mental) from Irmandade Santa Casa de Misericórdia de São Paulo; and d) the Psychosocial Community Center Luiz da Rocha Cerqueira, which is directed by the Universidade Federal de São Paulo, all located in the city of São Paulo.
Participants using any antipsychotic in the past three months, presenting a diagnosis on the schizophrenia spectrum confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID I-P) , aged between 18 and 65 years old, and being clinical stable, i.e., reaching less than 60 in the Positive and Negative Syndrome Scale (PANSS) scale  were asked to participate. They also needed to be motivated to lose weight or have showed some concern about weight gain. Participants were already enrolled in the outpatient units included in the study and were referred by either the clinician or a mental health worker of the team.
Patients were excluded if they were not clinically stable, in the presence of DM, or had a previous history of an eating disorder (Anorexia and Bulimia), or drug and alcohol abuse. Patients were not allowed to take any medication with the intention of controlling or reducing weight. Participants who agreed to take part in the study signed written informed consent and were randomly assigned to the intervention group or a standard care group using a randomization table available on the web site http://www.randomization.com. The protocol was submitted and approved by the Ethical Committee of each center.
The primary outcome was defined as weight and body mass index (BMI) changes. BMI was calculated as weight in kilograms divided by the square of the height in meters. Data on social and demographic characteristics, clinical data and physical examination (weight, height, BMI, waist circumference and blood pressure) were routinely recorded. Weight was recorded every month, in the morning, on the same scale (Kratos-cas Linea model), without shoes, with the individuals wearing light clothes. Waist was considered at the level of the navel. Blood pressure was measured twice, and the mean of both measures was considered. Measures were collected by the same investigator in all assessments.
Fasting plasma glucose, insulin, total cholesterol, HDL-cholesterol, LDL- cholesterol and triglycerides levels were assessed at baseline, and at three- and six-month follow-up. A surrogate of insulin resistance, the Homeostatic Model Assessment (HOMA-IR) was calculated at baseline, at three and six months .
Blind investigators applied the following instruments to participants of the trial at baseline and three-month follow up: the Positive and Negative Syndrome Scale (PANSS)  to evaluate the severity of the disease, the Calgary Depression Scale  to assess depression, Clinical Global Impression – Severity Scale (CGI-S)  and Clinical Global Impression- Improvement Scale (CGI-I)  to assess clinical global impression. Global functioning was evaluated by Global Assessment of Functioning (GAF) , and independent living skills by Independent Living Skills Survey- patient version (ILSS-BR/P) . Patients were asked to reply to the following self-rated scales: The World Health Organization's WHOQOL-BREF quality of life assessment- WHOQoL-BREF , Rosenberg self-esteem scale , Dietary Instrument for Nutrition Education (DINE) to classify dietary fat (satured and unsatured fat) and fiber intakes , Fagerström tolerance questionnaire to evaluate tobacco dependence , and International Physical Activity Questionnaire-short version (IPAQ)  to evaluate physical activity. IPAQ short form is an instrument designed primarily for population surveillance of physical activity among adults. IPAQ classifies physical activity into three categories: walking, moderate and vigorous activity.
Patients were evaluated at five moments during the study: baseline (physical examination, blood tests and scales), at one-month and two-month follow up (weight and BMI), at three-month follow up (physical examination, blood tests and scales), and at six-month follow up (physical examination and blood tests). No inputs about lifestyle were given after the 12-week program.
The sample size was estimated based in an open pilot study with 48 patients, where it was showed a weight difference of -1 kg (weight loss) and a standard deviation of 2 after three months. Taking into account a 35% of drop-outs (α=0.05, power 0.8), the expected number in each group was found to be 90 patients.
All randomized subjects were included in the initial analysis. Weight and BMI changes were defined as main outcomes. Two-sided t-tests and chi-square tests were used to analyze the differences between the groups at baseline and during follow-up.
ANOVA with repeated measures was used to compare the intervention versus standard care groups over time. We describe two types of p value, one that represents difference over time and the other that represents interaction between groups. Analyses of the main outcomes were based on the intention-to-treat analysis, with the Last Observation Carried Forward (LOCF) using weight and BMI measures of the last assessment available. An alpha level of .05 was set for all statistical tests. Data was analyzed using Statistical Package for Social Sciences, version 15 (SPSS Inc, Chicago, Illinois).