Study design and objectives
- The main issue that is addressed in this paper is associated with the effect of clozapine treatment among the patients with schizophrenia. It is reported that, following the treatment of clozapine, gaining weight is very common among the people who are treated with this medicine. Therefore the study, examined the impact of physical activity and dietary practices among the obese patients suffering from the disease schizophrenia. Therefore, it can be stated that, in the present study, the objective is clearly mentioned (Wu et al., 2007).
- From the study, it is observed that the study follows the randomized controlled study design. In the Eastern Taiwan, approximately clozapine-treated53 patients who are obese in nature (having the Body Mass Index of more than 27) are recruited in this study randomly to the control group or to the intervention group. The detailed sampling technique showed that, initially, 753 hospitalized patients’ data were collected in between September 2003 to February 2004 (Wu et al., 2007). All the patients in the selected sample population matched the criteria of DSM-IV diagnosis of schizophrenia and the all the patients were under age group of 18-65 years. Along with this, patients who are not taking medicine that is clozapine less than 300 mg were excluded from the study. Not only this, but the patients taking any kind of antipsychotic drugs or any type of lipid lowering medications were also not considered as ideal sample population for this study. The Asian individuals along with BMI of higher than 27kg/m2 were considered to be included in the present study. Moreover, the patients with any type of mental illness, persons with disability during walking, pregnant women are also not included in the study. After implementing all the inclusion and exclusion criteria, only 56 patients were eligible for the final study and they were randomly assigned to the control or intervention group of the study (Wu et al., 2007).
As a part of the intervention, primarily dietary intervention that is dietary control was implemented by the registered dietician. The registered dietician is responsible for taking care of the calorie intake of the patients who were included in this study (Wu et al., 2007). It is reported in the study that, the calorie intake of the women participants was restricted to 1300 kcal to 1500 kcal per day and on the other hand, in case of male subjects the calorie intake was restricted to the 1600 kcal to 1800 kcal per day. According to the study of Reid Baron and Zee (2014), it is reported that, the minimum dietary requirement for the women is approximately 1200 kcal per day and in case of males this dietary intake requirement is almost 1600 to 1800 kcal per day. As a part of this, the researchers measured the daily calorie intake of the participants and along with this, the type of foods such as artificial sweeteners, sugar free versions of foods and drinks, fruit and vegetables (up to 7.5 servings per day) consumed by those people was also analysed by the researchers. The study of Liu et al. (2018), reported that, the current average macronutrient intake of the Taiwan population is composed of 10-14% of protein diet, 20-30% of fat diet and 58 -68% of carbohydrate diet in terms of calorie supply to the body of the individuals (Wu et al., 2007).
Another important intervention that is implemented in this study is associated with the physical activity of the people. According to the US Surgeon general’s report, it was reported that, persons of all ages should have a minimum of 30 minutes physical activity every day and it is also mentioned that, the physical activity should be moderate in nature. According to the study of Duncan et al. (2015), it is reported that, as a part of the moderate intensity daily exercises, an individual may perform brisk walking on most of the days in a week. In this study, it was reported that, the authors had designed a different physical activity plan moderate in nature for the study participants. In this context, it can be stated that, the physical activity program of the current study comprised of a 6 months activity and all the physical activities designed for this program was performed by the individuals three days in a week by the study population of the current study (Wu et al., 2007). Therefore, it can be stated that , the physical activity program designed in such a way that , it can be performed in the hospital environment. In this physical activity program, the participants performed consisted level of walking for 1.62 km for approximately 40 minutes, performing stair case exercise that is walking up 231 stairs and walking down for 330 stairs. The measurement of the stair (walking up) was 14 cm per stair and the measurement of the stair (walking down) was 13.5 cm per stair. This stair activity lasted for 20 minutes under the supervision of the registered nurses of the hospital (Wu et al., 2007). The researchers also assured that throughout the 6 months period of exercise intervention, the walking speed of the participants and distances of the walking were same and only the intensity of the warm up exercises were changed during the 6 months period. As a part of this, the researchers encouraged the participants to perform the warm exercises within 60 minutes ; however the participants were instructed not to force themselves during the exercise schedule. It was estimated that during the performances of the physical activity, the participants approximately expended energy at a specific rate of 600 to 750 kcal per week. Along with this, in order to motivate the participants towards the exercise program, different motivational activities were performed and as a part of this, the participants were performed various rewards such as sugar-free drinks, soap and toilet paper (Wu et al., 2007).
Intervention details
The main outcome of this study showed that dietary control program and regular physical activity program can significantly decrease the body weight and along with this, the intervention can also improve metabolic profiles of IGFBP-3, triglyceride and insulin among obese inpatients taking clozapine for the treatment of schizophrenia (Wu et al., 2007).
The collected data was analysed by using the variance and covariance analysis (ANCOVA) with SPSS statistical software (version 10.0). The anthropometric data, hormonal profile and metabolic data of the participants in the intervention group were compared with the data of the control group participants at beginning of the study and the same analysis was performed after three months and at the end of the study. The data that were collected at the initiation of the study were used as the covariate in this study. While performing the analysis of the collected data, a repeated measure ANCOVA was used for all the baseline data (Wu et al., 2007). For adjusting the cofounding variables, mix-designed ANCOVA was used and this same method was also used for testing the correlation in between the variables. In this study, for all the cases p value of 0.05 was considered as significant. The study result showed that only 53 patients completed the whole process and from the control group 3 people withdrew themselves from the study as they were discharged from the hospital. After identifying the subjects in this study, 25 patients were assigned to the control group and on the other hand, 28 persons were assigned to the intervention group of the study. In the control group, 44 per cent of the subjects were male and rest of the population that were female that is 56 per cent of the total population was female. On the other hand, in the intervention group there were 17 women and 11 men along with the mean age group of 42.2±7.5 years (Wu et al., 2007). However, no significance differences were found in between the two groups in terms of age or gender of the participants. While discussing the anthropometric measures that is BMI, waist-to-hip ratio waist and hip circumference, body weight, and fat percentage of body weight, it was found that, there was no significant differences in between the two study groups. From the study, it can be reported that, all the study findings were presented in a tabular formant. From the result table, it was observed that, at the baseline data no significant differences regarding the body fact percentages among the men (30.9%±4.8% in the study group and 30.0%±5.1% in the control group) and among women (43.6%±10.7% and 41.4%±5.7%, respectively) (Wu et al., 2007). However, the body fat percentage of the men was significantly lower than that of the body fat percentage of the women (p<0.001); however free fat mass among the men was higher than that of the female. As shown in the table 1, body fat percentages at three and six months were not reduced within the intervention group participants and also among the intervention group and control group population of the present study. Therefore after three and six months, the difference in between the free fat percentages of in between the women and men disappeared in between the men and women of the study population. Although no difference was found in between the above said parameters, reduction in the parameters in the study group like body weight, BMI and waist and hip circumference measures were observed (Wu et al., 2007). All the parameters decreased significantly (p<0.05) after three and six months period among the intervention group compared with the control group of the study. However, the hip circumference of the study population in the intervention group was reduced only after the 6 months of the intervention. The researchers found that, significant differences were found among the intervention group participants after the three months in the parameters like body weight, BMI, hip circumferences but the waist circumference was reduced among the intervention group only after 6 months of the intervention (Wu et al., 2007).
Main outcome and analysis
On the other hand, the data presented in the table 2 of this study, it was reported that, no differences were found at the baseline data of the insulin levels, prolactin, triglyceride, cortisol, cholesterol and serum glucose among the control and intervention group of the study. However, during the intervention process at 3 and 6 months significant differences were noted in between the control and intervention group. While discussing about the levels of the triglyceride among the participants, it was reported that, there was significant differences in between the control and intervention group at the six months of the study (Wu et al., 2007). However, the study failed to show any significant differences in between the control and intervention group the study regarding the insulin levels, prolactin, triglyceride, cortisol, cholesterol and serum glucose after three months and six months of the intervention. Along with this, significant decrease in the triglyceride and cortisol concentrations at 3 and 6 months of the intervention was reported among the patients and on the contrary, in case of insulin levels changes were observed only 6 months of the intervention of the present study Surprisingly, the triglyceride level of the control group significantly enhanced at 6 months compared to the level of 3 months (Wu et al., 2007).
In case of the growth hormone level of the study population, it was reported that, no changes were reported in between the study and control group of the study regarding the level of growth hormone, IGF-1, IGFBP-3, and the molar ratio of IGF-1 and IGFBP-3. From the data of table 3 of the study it was reported that, there were no changes in the levels of IGF-1 and growth hormone levels among the intervention and control group participants even after 3 months and 6 months (Wu et al., 2007). Although level of IGFBP-3 was similar among the participants of both groups, still at the end of 6 months, the level of IGFBP-3 was lower among the intervention group than that of the control group of the study. Surprisingly, it was found that, the participants of the control groups had higher level of these growth factors after six months compared to the level of the baseline data of the study. The molar ratio of the IGFBP-3 and IGF-1 of the study group showed no significant differences while compared with the data of the control group (Wu et al., 2007).
Study population and characteristics
As a part of the future direction of the present study, the researchers proposed that, life style medication can be prescribed to prevent obesity related abnormalities and in various studies this findings were also reported (Wu et al., 2007).
While discussing the chance variance of the study, it can be stated that, no chance variance was present in the study. However, while discussing the biases of the present study, it can be stated that, the due to lack of adequate work forces and work site support, it was not possible to monitor all the study participants. Therefore, it may be stated that, lack of proper observation of the patients can be marked as study bias (Wu et al., 2007).
In this regard, it can be stated that, the level of the physical fitness of the study population can be accounted as one of the confounding factors of this study. According to the study of Attux et al. (2013), it is stated that the intensity of the exercise is correlated with the level of fitness and so an individual with low level of physical fitness is not capable of performing exercises at same level like a physically fit person. However, the authors did not consider the level of physical fitness of the individuals during the sampling process and so it may affect the study result as all the subjects will not be able to perform exercises in a same manner (Wu et al., 2007).
Yes, sub group analysis was performed in this study in terms of the gender of the study population. The study discussion showed that, there was different outcome for men and women. The average waist-hip ratio of the clozapine- treated patients with schizophrenia was 0.97 for men and 0.88 for women. According to the study of Du et al. (2017), it is reported that, Japanese criteria for central obesity are 0.9 for men and 0.8 for women. Therefore, the present study reported that both men and women had central obesity.
As per the study discussion, it can be stated the causal relationship in between exposure and outcome is plausible as in various other studies, this association is also established by the authors. According to the report of Xu et al. (2017), it is stated that community based physical activity interventions are quite effective in improving the obesity condition among the community people. This study finding also supported the credibility of the nutritional intervention program that is also found in the study of Wu et al. (2007). Another study by Martin et al. (2018) reported that, use of healthy diet and regular physical activity are highly associated with the reduction of obesity. Therefore, it can be stated that, the study findings of the present study is quite relevant. Taylor et al. (2018) also stated that, physical intervention can reduce the prevalence of the obesity among the selected study population.
Metabolic profile findings
The findings of the study cannot be applied to other population as the exposure-outcome relationship is completely based on those who use clozapine due to schizophrenia. However, in case of such type of patients, the study findings can be applied. Yes, the study findings can be applied to other population as from the previous study findings it is clear that physical activity and nutritional intervention are effective in reducing obesity among the people.
References
Attux, C., Martini, L. C., Elkis, H., Tamai, S., Freirias, A., Camargo, M. D. G. M., … & Bressan, R. A. (2013). A 6-month randomized controlled trial to test the efficacy of a lifestyle intervention for weight gain management in schizophrenia. BMC psychiatry, 13(1), 60.
Du, P., Wang, H. J., Zhang, B., Qi, S. F., Mi, Y. J., Liu, D. W., & Tian, Q. B. (2017). Prevalence of abdominal obesity among Chinese adults in 2011. Journal of epidemiology, 27(6), 282-286.
Duncan, M. J., Stanley, M., Smith, M., Price, M. J., & Leddington Wright, S. (2015). Coincidence anticipation timing performance during an acute bout of brisk walking in older adults: effect of stimulus speed. Neural plasticity, 2015.
Liu, Y. T., Hsu, C. S., Chang, C. C., & Hsu, S. H. (2018, October). Nutrition Security and Optimal Dietary Intake in Taiwan. In a workshop at Institute for Food and Resource Economics, University of Bonn (Vol. 17).
Martin, A., Booth, J. N., Laird, Y., Sproule, J., Reilly, J. J., & Saunders, D. H. (2018). Physical activity, diet and other behavioural interventions for improving cognition and school achievement in children and adolescents with obesity or overweight. Cochrane Database of Systematic Reviews, (1).
Reid, K. J., Baron, K. G., & Zee, P. C. (2014). Meal timing influences daily caloric intake in healthy adults. Nutrition research, 34(11), 930-935.
Taylor, R. W., Gray, A. R., Heath, A. L. M., Galland, B. C., Lawrence, J., Sayers, R., … & Hatch, B. (2018). Sleep, nutrition, and physical activity interventions to prevent obesity in infancy: follow-up of the Prevention of Overweight in Infancy (POI) randomized controlled trial at ages 3.5 and 5 y. The American journal of clinical nutrition, 108(2), 228-236.
Wu, M.K., Wang, C.K., Bai, Y.M., Huang, C.Y. & Lee, S.D. (2007). Outcomes of obese, clozapine-treated inpatients with schizophrenia placed on a six-month diet and physical activity program. Psychiatric services, 58(4),544-550.
Xu, F., Marchand, S., Corcoran, C., DiBiasio, H., Clough, R., Dyer, C.S., Nobles, J., White, J., Greaney, M.L. & Greene, G.W. (2017). A community-based nutrition and physical activity intervention for children who are overweight or obese and their caregivers. Journal of obesity, 2017.