MNT: Weight Management (2015)

Wong V, Chan R, Wong G, Cheung B, Chu W, Yeung D, Chim A, Lai J, Li L, Sea M, Chan F, Sung J, Woo J, Chan H. Community-based lifestyle modification programme for non-alcoholic fatty liver disease: a randomized controlled trial. Journal of Hepatology, 2013; 59: 536-542. PubMed ID: 23623998
Study Design:
Randomized Controlled Trial
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:
To assess the efficacy of a community-based lifestyle modification program in the remission of NAFLD.  
Inclusion Criteria:
  • 18 years to 70 years of age
  • Fatty liver by H-MRS, defined as intrahepatic triglyceride content of 5% or more
  • Plasma alanine aminotransferase above 30 IU per L in men, 19 IU per L in women.  
Exclusion Criteria:
  • Testing positive for Hepatitis B surface antigen or anti-hepatitis C virus antibody
  • Anti-nuclear antibody titer above 1/160
  • ETOH over 20g per day in men and over 10g per day in women
  • Liver decompensation
  • Terminal illness and cancer.
Description of Study Protocol:
  • Recruitment: Local citizens were invited to be screened with H-MRS
  • Design: Parallel group, superiority, single-blind RCT comparing lifestyle modification program with usual care in NAFLD patients
  • Blinding used (if applicable): Single-blind.


  • RD-led lifestyle modification program (increasing energy expenditure, reducing kcal intake using lifestyle behavior change) for 12 months via individual education sessions: Weekly for first four months, monthly for the remaining eight months
  • Initial session was one hour and included a complete behavioral assessment
  • Follow-up sessions were 20 minutes to review dietary practices and provide recommendations
  • All subjects were given individual meal plans, emphasizing fruit and vegetable intake, increased protein intake, moderate CHO and low-fat, low-GI, appropriate portions
  • Adherence was assessed by calculating percentage of attendance to sessions and evaluating dietary intakes and meal patterns, using weekly food records.
  • Subjects were also encouraged to see an exercise instructor at least once during the study
  • Initial consultation (30 minutes) included an individual program including moderate-intensity aerobic exercise for 30 minutes three to five times per week and increasing daily physical activities
  • Follow-up appointments evaluated progress
  • Target was reduction of BMI towards 23 kg/m2
  • Control Group was under usual or standard care per clinician at baseline (explanation of labs, encouraged to reduce CHO and fat intakes and to increase exercise to at least 30minutes per day three times per week.

Statistical Analysis

  • T-test between groups to compare continuous variables
  • Chi-square test for categorical variables
  • Intent-to-treat analysis for each outcome
  • P<0.05 as significant.
Data Collection Summary:

Timing of Measurements

Baseline measurements and then follow-up at the clinic at Months Three, Six, Nine and 12 for metabolic assessment.

Dependent Variables

  • Adherence: Percentage of session attendence and dietary intake per weekly food records
  • Body weight, BMI, waist circumference
  • Physical activities recorded in minutes per week
  • H-MRS and liver stiffness at baseline and end-point, to assess hepatic steatosis and fibrosis
  • Liver biochemistry
  • Fasting glucose
  • Lipids.

Independent Variables

Lifestyle modification intervention vs. conntrol (standard care).

Control Variables

Timing of measurements.

Description of Actual Data Sample:
  • Initial N: 1,069 screened; 154 randomized [77 to the intervention (41 male); 77 to the control (31 male)]
  • Attrition (final N): 77 in the intervention (three lost to follow-up); 77 in the control (six lost to follow-up)
  • Age: 51±9 years in intervention and control
  • Ethnicity: Chinese
  • Anthropometrics: BMI, 25.5±3.9 in intervention; 25.3±3.2 in control
  • Location: Hong Kong, China.
Summary of Results:

Key Findings

  • 83% subjects in the Intervention Group attended more than 80% of the dietary consultation sessions. 84% of the Intervention Group attended exercise consultation sessions.
  • Remission of NAFLD at 12 months occurred in 64% subjects in the Intervention Group and in 20% of subjects in the Control Group (P<0.001)
  • Lifestyle intervention, decreased body weight and waist circumference and reduced cholesterol were associated with remission in univariate analyses, however only reduced body weight remained an independent predictor associated with remission by multivariate analysis.
  • The Intervention Group had a greater reduction in body weight, BMI and waist circumference, ALT, liver stiffness and LDL-cholesterol at 12 months. Weight loss was associated with remission in a dose-dependent manner.


Treatment Group
Measures and confidence intervals

Control Group
Measures and confidence intervals

Statistical Significance of Group Difference

Change IHTG




Change Liver Stiffness




Change in Body Weight -5.6±4.4kg -0.6±2.5kg <0.001

Change in Waist Circumference



Change in ALT (IU/L) -17±30 -7±19 0.011
Change in LDL (mmol/L) -0.3±1.0 -0.2±0.6 0.28


Author Conclusion:
  • A community-based lifestyle modification program is effective at normalizing liver fat in NAFLD patients
  • While the effect is proportional to the degree of weight loss, many patients with weight loss of at least 3% have remission of NAFLD.  
Funding Source:
Government: Nutritional Research FOundation of the UK; Research Grants Council of the Hong Kong SAR
University/Hospital: Chinese Univ of Hong Kong
Reviewer Comments:
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) Yes
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? Yes
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? Yes
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? Yes
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) Yes
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? Yes
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? Yes
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? N/A
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  6.8. In diagnostic study, were details of test administration and replication sufficient? Yes
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? Yes
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? Yes
  8.6. Was clinical significance as well as statistical significance reported? No
  8.7. If negative findings, was a power calculation reported to address type 2 error? N/A
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes