Data_Sheet_1_Calorie-restricted diet mitigates weight gain and metabolic abnormalities in obese women with schizophrenia: a randomized controlled trial.docx

BackgroundObesity is a prevalent health problem in patients with schizophrenia, and calorie restriction diet (CRD) achieved effective weight loss and metabolic improvement; however, these have not been rigorously evaluated in obese patients with schizophrenia. ObjectiveTo measure the effects of CRD on weight loss and metabolic status in hospitalized obese women with schizophrenia during a 4-week period. MethodsParticipants were randomly assigned to two groups in a 1:1 ratio. The intervention group (n = 47) was asked to follow a CRD and the control group (n = 48) a normal diet for 4 weeks. Outcomes of body weight, body composition, as well as metabolic parameters were measured at baseline and following the intervention period. ResultsForty-five participants completed the 4-week research in both the intervention and control groups. Compared to the normal diet, adherence to the CRD significantly decreased body weight (2.38 ± 1.30 kg), body mass index (0.94 ± 0.52 kg/m2), waist circumference (4.34 ± 2.75 cm), hip circumference (3.37 ± 2.36 cm), mid-upper circumferences, triceps skin-fold thickness, fat mass and free fat mass with large effect sizes (p = <0.001, ηp2 range between 0.145 and 0.571), as well as total cholesterol (0.69 ± 0.70 mmol/L) with a medium effect size (p = 0.028, ηp2 = 0.054). There were no differences between the CRD and control groups in terms of pre-post changes in triglycerides, high- and low-density lipoprotein-cholesterols, as well as systolic and diastolic blood pressures (p > 0.05). ConclusionCRD is preventative of weight gain, but not apparent in intervention for metabolic status in hospitalized obese women with schizophrenia. Clinical trial registration: http://www.chictr.org.cn, ChiCTR-INR-16009185.背景：肥胖是精神分裂症患者中普遍存在的健康问题，热量限制饮食（calorie restriction diet, CRD）可实现有效的减重与代谢改善，但此类干预尚未在精神分裂症肥胖患者中得到严格评估。 目的：评估为期4周的热量限制饮食（CRD）对住院精神分裂症肥胖女性患者的减重效果与代谢状态的影响。 方法：研究对象以1:1的比例随机分为两组。干预组（n=47）需遵循热量限制饮食，对照组（n=48）则采用正常饮食，干预周期均为4周。分别于基线与干预结束后测量体重、身体成分及代谢相关参数。 结果：干预组与对照组均有45名受试者完成了为期4周的研究。与正常饮食组相比，遵循热量限制饮食可显著降低体重（2.38±1.30 kg）、体重指数（body mass index, BMI）（0.94±0.52 kg/m²）、腰围（4.34±2.75 cm）、臀围（3.37±2.36 cm）、上臂围、肱三头肌皮褶厚度、脂肪量与去脂体重，且效应量较大（p<0.001，ηp²范围为0.145~0.571）；同时可显著降低总胆固醇（0.69±0.70 mmol/L），效应量中等（p=0.028，ηp²=0.054）。两组在甘油三酯、高密度脂蛋白胆固醇与低密度脂蛋白胆固醇的前后变化，以及收缩压、舒张压方面均无显著差异（p>0.05）。 结论：热量限制饮食可预防体重增加，但在改善住院精神分裂症肥胖女性患者的代谢状态方面效果并不显著。 临床试验注册：http://www.chictr.org.cn，ChiCTR-INR-16009185。