Elsevier

Journal of Hepatology

Volume 59, Issue 3, September 2013, Pages 536-542
Journal of Hepatology

Research Article
Community-based lifestyle modification programme for non-alcoholic fatty liver disease: A randomized controlled trial

https://doi.org/10.1016/j.jhep.2013.04.013Get rights and content

Background & Aims

Healthy lifestyle is the most important management of non-alcoholic fatty liver disease (NAFLD). This study aimed at assessing the efficacy of a community-based lifestyle modification programme in the remission of NAFLD.

Methods

This was a parallel group, superiority, randomized controlled trial. 154 adults with NAFLD identified during population screening were randomized to participate in a dietitian-led lifestyle modification programme at 2 community centres or receive usual care for 12 months. The primary outcome was remission of NAFLD at month 12 as evidenced by intrahepatic triglyceride content (IHTG) of less than 5% by proton-magnetic resonance spectroscopy.

Results

74 patients in the intervention group and 71 patients in the control group completed all study assessments. In an intention-to-treat analysis of all 154 patients, 64% of the patients in the intervention group and 20% in the control group achieved remission of NAFLD (difference between groups 44%; 95% CI 30–58%; p <0.001). The mean (SD) changes in IHTG from baseline to month 12 were −6.7% (6.1%) in the intervention group and −2.1% (6.4%) in the control group (p <0.001). Body weight decreased by 5.6 (4.4) kg and 0.6 (2.5) kg in the two groups, respectively (p <0.001). While 97% of patients with weight loss of more than 10% had remission of NAFLD, 41% of those with weight loss of 3.0–4.9% could also achieve the primary outcome.

Conclusions

The community-based lifestyle modification programme is effective in reducing and normalizing liver fat in NAFLD patients.

Introduction

Non-alcoholic fatty liver disease (NAFLD) affects 15–40% of the general adult population and is the most common cause of abnormal liver biochemistry worldwide [1], [2]. Some patients with NAFLD run a progressive clinical course and may develop cirrhosis and hepatocellular carcinoma [3], [4], [5], [6].

Lifestyle modification is the cornerstone of the management of NAFLD [7]. Weight reduction by dietary intervention and/or exercise is associated with decrease in liver enzymes [8], [9], [10], [11], reduced liver fat [12], [13], [14], [15], and improvement in liver histology [16], [17]. However, 2 important questions remain unanswered. First, the majority of NAFLD patients are seen at the primary care setting. Reported intervention programmes were invariably conducted in expert centres. The implementation and efficacy of lifestyle modification programmes at the community setting are unclear. Second, many reported interventions involved tightly controlled diet over short periods ranging from several weeks to months. It is unlikely that patients can adhere to such diets for a long time. The optimal intervention with good efficacy and sustainability for patients with NAFLD is currently unknown.

This study tested the hypothesis that a community-based lifestyle modification programme is superior to usual care in normalizing hepatic steatosis in patients with NAFLD.

Section snippets

Trial design

This was a parallel group, superiority, single-blind randomized controlled trial comparing a community-based lifestyle modification programme with usual care in NAFLD patients.

Study population

NAFLD patients were recruited from a population screening project in Hong Kong. Details of the project have been described previously [2], [18]. In brief, a list of local citizens was randomly generated from the government census database. They were invited to undergo screening with proton-magnetic resonance spectroscopy (

Study subjects

Of 1069 people who underwent population screening from May 2008 to September 2010, 251 had NAFLD, of which 154 had abnormal ALT level and consented to join the trial (Fig. 1). 77 patients were randomized to the lifestyle modification programme and 77 received usual care. Three patients in the intervention group and 6 in the control group were lost to follow-up, but all randomized patients were included in the intention-to-treat analysis. The two groups were well-matched in demographic

Discussion

In this randomized controlled trial, a community-based lifestyle modification programme resulted in remission of NAFLD in the majority of patients. The efficacy on weight reduction was sustainable at 1 year. Although the chance of NAFLD remission increased with the degree of weight loss in a dose-response fashion, over 40% of patients with weight loss of as little as 3.0–4.9% of the baseline body weight also achieved remission of NAFLD.

In a randomized controlled trial of 31 overweight or obese

Financial support

This study was supported in part by the Nutritional Research Foundation of the United Kingdom, the direct grant of the Chinese University of Hong Kong (ref 2011.1.025) and a grant from the Research Grants Council of the Hong Kong SAR (Project No. SEG CUHK_02).

Conflict of interest

Vincent Wong, Grace Wong, and Henry Chan have received paid lecture fees from Echosens.

Acknowledgements

We would like to thank Cheong-Chun Chan from Jockey Club School of Public Health and Primary Care for dietary data entry and analysis. We also thank the following medical and nursing students for their help in clinical data collection and entry: Yik-Ching Hung, Queenie Lau, Kam-Ho Lui, Long-Hei Siu, Kelvin Wan, Ho-On Wong, and Ronald Wong.

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    ClinicalTrials.gov NCT00868933.

    These authors contributed equally to this work.

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