Subjects with SMI
A total of 989 psychiatric patients were recruited for the study (774 women and 215 men) and gave written informed consent. Patients were recommended to participate in the study by psychiatrists working either privately or in hospital offices in Thessaloniki (Greece). The study was carried out from January 2007 to November 2009. The study has been approved by the ethical committee of the Technological Educational Institute of Thessaloniki (Ref. No 20111). All patients were found competent by an independent psychiatrist, who was not involved in the study, to participate and to follow weight loss intervention at the enrollment visit. All patients continued on treatment with their medication. Antipsychotic drugs were being used by 28% of patients (n = 274), 30% of patients were taking antidepressants (n = 297), 23% of patients were taking both antipsychotics & antidepressants (n = 230) and 19% of patients (n = 288) were taking antipsychotics & antidepressants, as well other types of medication (e.g. acholytic, antiparkinson, antiepileptic). Medication was kept constant for every patient.
Prior to the baseline assessment, patients visited the dietitian for familiarization with study design and measurements. The dietitian explained the study design and measurements thoroughly and then patients' relevant questions were answered.
At the beginning of the study (baseline-visit A), at 3 mo, 6 mo and 9 mo of the nutritional intervention (visit B, C and visit D respectively), several anthropometric measurements were undertaken to assess the outcome of the nutritional intervention program. All the measurements were carried out by the same two dietitians.
Body weight was measured on a standing scale calibrated to 0.1 kg (Seca digital scale). Body height was measured on a wall-mounted stadiometer. The subjects stood with legs parallel and shoulder-width apart. Waist circumference (WC) was measured at the end of normal expiration at the minimal waist (smallest horizontal circumference above the umbilicus and below the xiphoid process). Hip circumference (HP) was measured around the maximum circumference over the buttocks.
Body Fat was measured by the bioelectrical impedance analysis (BIA, Akern version 1.31). During the 9 mo period, subjects were asked to visit the nutrition unit every 2 wks. At these visits, body weight, waist circumference and body fat were measured by the same dietitian. For patients who dropped out, body weight was recorded and BMI was calculated when the drop out occurred.
The intervention period lasted 9 months and consisted of 2 phases: a familiarization visit and an intensive 9 month nutritional intervention period. The dietary advice for weight control was given in each patient by a registered dietitian. It was based on a Mediterranean-style diet in combination with personalized healthy nutrition counselling. Each patient received personalized dietary regimen on the basis of dietary history and lifestyle. The dietary regimen was characterized by a moderate consumption of carbohydrates (50-55% of total energy per day) and a high fiber content, 15-20% protein and a fat intake of 30-35% of total energy per day. Moreover, patients were advised to consume fruits, vegetables, whole grains (legumes, rice, maize, and wheat) daily and to increase their consumption of olive oil. The dietary regimen was designed to produce an energy deficit of 500 kcal per week. The patients were visiting the dietitian every two weeks to discuss weight changes and treatment goals.
The Resting Metabolic Rate (RMR) was measured by indirect calorimetry (Fitmate Pro, Cosmed USA Inc.) during their first visit. All patients completed a physical activity record. RMR was multiplied by an activity factor of 1.3-1.5, according to the physical activity level of each patient, and daily energy requirements of each patient were estimated. The intervention program consisted primarily of dietary counseling, physical activity counseling and behavioral interventions in order to aid patients' adherence to a healthy life plan during the nutritional intervention. Counseling sessions were undertaken individually by each patient and included teaching healthful weight management techniques, meal planning, food shopping and preparation, portion control, techniques to differentiate emotional from psychological hunger etc. In terms of physical activity counseling, subjects were instructed to participate in light or moderate exercise at least 30 min 3-5 times per week.
Biochemical measurements were undertaken at the beginning of the study (baseline-Visit A), at 3 mo (Visit B), 6 mo (Visit C) and 9 mo (Visit D) of the nutritional intervention. Data regarding plasma glucose, total cholesterol, HDL cholesterol and triglycerides were recorded by the dietitian.
Data are expressed as means and standard deviations (SD). Within-subject paired t-tests compared initial vs end point measures for subjects that completed the 9 mo intervention. Comparisons between completers and drop-outs were performed using independent sample t-tests. In order to compensate for missing data due to withdrawal, the last-observation-carried-forward (LOCF) method was used and paired t-tests were performed against the LOCF data as well. Correlation analysis was also carried out for associations between body weight change and body fat percentage (BF %) change over time (baseline to 3 mo, 6 mo and 9 mo). Statistical significance was taken as P < 0.05. The statistical analysis was processed with SPSS 11 for Windows (SPSS, Inc., Chicago, IL, USA).