A randomized controlled trial of therapeutic lifestyle modification in rural women with metabolic syndrome: a pilot study Eui-Geum Oh a, ⁎ , Sa Saeng Hyun b , Soo Hyun Kim b , So-yeoun Bang c , Sang Hui Chu a , Justin Y. Jeon d , Myung Sook Kang b a College of Nursing, Nursing Policy and Research Institution, Yonsei University, Seoul 120-752, Korea b College of Nursing, Yonsei University, Seoul 120-752, Korea c HaeChun College, Yonsei University, Seoul 120-752, Korea d Department of Sport and Leisure Studies, Yonsei University, Seoul 120-752, Korea Received 26 February 2007; accepted 13 September 2007 Abstract The aim of the study was to identify the effects of the therapeutic lifestyle modification (TLM) program on women with the metabolic syndrome in rural areas. Thirty-two women with the metabolic syndrome were randomly assigned to the intervention or control group. The women in the intervention group participated in a 4-week TLM program consisting of health screening, education, exercise, diet, and counseling. Those in the control group received a booklet with basic education for metabolic syndrome. Repeated-measures analysis of variance was used for analyzing the effects of the TLM intervention on anthropometric indicators, serologic assays, and psychosocial outcomes. The participants in the intervention group showed significant reductions in body weight (-4.6 kg vs -2.0 kg), waist circumference (-6.2 cm vs -1.7 cm), and triglyceride levels (-52.2 mg/dL vs -2.2 mg/dL) compared with those in the control group at 4 weeks (P b .01). In addition, the TLM intervention group showed significant positive behavior changes; almost all of the women tried to control their intake of food and their weight and to exercise 3 times per week. The TLM intervention showed no group and time interaction effect on systolic blood pressure, fasting glucose, high-density lipoprotein cholesterol, or low-density lipoprotein cholesterol levels. However, there was a positive time effect; after the program, high-density lipoprotein cholesterol levels increased and systolic blood pressure, fasting glucose, and low-density lipoprotein cholesterol decreased compared with levels before the intervention in both groups. These results indicate that a well-developed comprehensive TLM intervention can improve metabolic syndrome over a short-term period. © 2008 Elsevier Inc. All rights reserved. 1. Introduction Metabolic syndrome, also called syndrome X, is char- acterized by insulin resistance, abdominal obesity, elevated blood pressure, and lipid abnormalities [1]. The clustering of risk factors called the metabolic syndrome confers an increased risk of cardiovascular disease–related morbidity and mortality [2,3] and all-cause mortality, even in the absence of clinically evident cardiovascular disease and/or diabetes mellitus [3]. The Third Report of the National Cholesterol Education Program Adult Treatment Panel (NCEP-ATP III) has recommended appropriate measures to identify individuals with the metabolic syndrome and to manage their care before development of cardiovascular complications [4]. Difference in prevalence of metabolic syndrome has been reported in previous studies [1,5-7]. The prevalence is increased in middle- or older-aged women [5,8]. Over the past decades, South Korea has experienced rapid socio- economic growth, resulting in lifestyle changes that promote the development of components of metabolic syndrome within the population [8]. Using the NCEP-ATP III definition of metabolic syndrome, it was found that its age- Available online at www.sciencedirect.com Metabolism Clinical and Experimental 57 (2008) 255 – 261 www.elsevier.com/locate/metabol ⁎ Corresponding author. Division of Clinical Nursing Science (Adult Health Nursing), College of Nursing, Nursing Policy and Research Institution, Yonsei University, 134 Shinchon-Dong, Seodaemun-Gu, PO Box 8044, Seoul 120-752, Korea. Tel.: +82 2 2228 3256; fax: +82 2 392 5440. E-mail address: euigeum@yumc.yonsei.ac.kr (E.-G. Oh). 0026-0495/$ – see front matter © 2008 Elsevier Inc. All rights reserved. doi:10.1016/j.metabol.2007.09.009