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PDM: Metabolic Syndrome (2013)

Citation:

Munakata M, Honma H, Akasi M, Araki T, Kawamura T, Kubota M, Yokokawa T, Numata Y, Toyonaga T, J-STOP-MetS Study Group. Repeated counselling improves the antidiabetic effects of limited individualized lifestyle guidance in metabolic syndrome: J-STOP-METS final results. Hypertens Res. 2011; 34 (5): 612-616.

PubMed ID: 21228781
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:

The purpose of this study was to examine whether additional repeated counseling further improves the health effects of limited, highly individualized lifestyle guidance in metabolic syndrome.

Inclusion Criteria:
  • Diagnosed with metabolic syndrome that includes a waist circumference of over 85cm, with at least two of the following three cardiovascular risk factors: High blood pressure (systolic blood pressure at or above 130mmHg or diastolic blood pressure at or above 85mmHg), hyperglycemia (fasting blood sugar at least 110mg per dL) or dyslipidemia (triglyceride at least 150mg per dL or high density lipoprotein under 40mg per dL)
  • Provided informed consent.
Exclusion Criteria:
  • Severe obesity (body mass index of at least 35kg/m2)
  • Uncontrolled diabetes mellitus (fasting blood glucose at or above 160mg per dL or HbA1c at or above 8%)
  • Renal failure (plasma creatinine concentration of at least 1.5mg per dL)
  • Previous history of cardiovascular disease, cancer or other serious diseases.
Description of Study Protocol:

Recruitment

  • Patients who underwent annual health check-ups or those who were referred from outpatient clinics for further examination of hypertension, diabetes mellitus or dyslipidemia were recruited
  • The advertisement was announced in a health promotion lecture for the general population and in health-promoting magazines.

Design

Randomized controlled trial.

Blinding Used

Implied with measurements.

Intervention

  • Subjects were randomly assigned to either the Single Guidance or the Multiple Guidance Group
  • Subjects in the Multiple Guidance Group visited each center every two months and received a re-evaluation of body weight, waist circumference and body composition
  • If a subject's target body weight was not achieved at each visit, the cause was evaluated by an interview conducted by a trained nurse, dietitian and exercise trainer and corrected advice was presented to the subject
  • Subjects in the Single Guidance Group were requested to practice the weight reduction program on their own at the same 5% loss rate every two months
  • All subjects received highly standardized and individualized lifestyle guidance for weight loss before randomization. A physician explained the pathophysiology of metabolic syndrome, the risk of future cardiovascular events due to this condition and the rationale for prescribing weight loss and its importance in the maintenance of each subject's health.
  • A trained nurse conducted the behavioral modification therapy
  • Behavioral therapy involved the following:
    1. Recognition of unhealthy dietary habits
    2. Record-keeping of body weight
    3. Stimulus control
    4. Smoking cessation.
  • A dietitian provided advice on how to achieve the reduction in calorie intake and modify dietary lifestyle
  • Finally, the subjects were encouraged to increase physical activity to reduce fat volume. The goal of increased physical activity was at least 30 minutes of moderate physical activity per day, at least five days per week. Patients were advised to gradually increase their level of physical activity to avoid bone and joint damage. The total amount of physical activity per week corresponded to about 10 exercises, which is the recommended level of physical activity to ameliorate metabolic syndrome.

Statistical Analysis

  • Data was expressed as mean±SD
  • Differences between the groups at baseline were studied with an unpaired T-test or Mann-Whitney test for continuous variables according to the distribution of the data
  • Plasma triglyceride concentration, aspartate aminotransferase, alanine aminotransferase and gamma-glutamyl transpeptidase were studied by Mann-Whitney test and other variables were studied by the T-test
  • Categorical variables were examined by X2 test
  • The treatment effect was examined by paired T-test or Wilcoxon test
  • Comparison of the changes in each parameter between the Single Guidance and the Multiple Guidance Groups was done by analysis of covariance
  • All analyses were performed with commercially available software
  • A P-value of <0.05 was considered significant. 
Data Collection Summary:

Timing of Measurements

Baseline and six months after the first guidance session.

Dependent Variables

  • Body weight, waist circumference and metabolic syndrome components
  • Arterial stiffness, as assessed by the baPWV, was also evaluated.

Independent Variables 

  • Subjects were randomly assigned to either the Single Guidance or the Multiple Guidance Group
  • Subjects in the Multiple Guidance Group visited each center every two months and received a re-evaluation of body weight, waist circumference and body composition
  • If a subject's target body weight was not achieved at each visit, the cause was evaluated by an interview conducted by a trained nurse, dietitian and exercise trainer and corrected advice was presented to the subject
  • Subjects in the Single Guidance Group were requested to practice the weight reduction program on their own at the same 5% loss rate every two months
  • All subjects received highly standardized and individualized lifestyle guidance for weight loss before randomization. A physician explained the pathophysiology of metabolic syndrome, the risk of future cardiovascular events due to this condition and the rationale for prescribing weight loss and its importance in the maintenance of each subject's health.
  • A trained nurse conducted the behavioral modification therapy
  • Behavioral therapy involved the following
    1. Recognition of unhealthy dietary habits
    2. Record-keeping of body weight
    3. Stimulus control
    4. Smoking cessation.
  • A dietitian provided advice on how to achieve the reduction in calorie intake and modify dietary lifestyle.
  • Finally, the subjects were encouraged to increase physical activity to reduce fat volume. The goal of increased physical activity was at least 30 minutes of moderate physical activity a day at least 5 days a week. Patients were advised to gradually increase their level of physical activity to avoid bone and joint damage. The total amount of physical activity per week corresponded to about 10 exercises which is the recommended level of physical activity to ameliorate metabolic syndrome.
Description of Actual Data Sample:
  • Initial N: 109 men and women; 52 in the Multiple Guidance Group (39 men) and 57 in the Single Guidance Group (38 men)
  • Attrition (final N): 95 subjects; 45 in the Multiple Guidance Group and 50 in the Single Guidance Group
  • Age: Mean age at baseline was 50±10 years in the Single Guidance Group and 50±10 years in the Multiple Guidance Group
  • Ethnicity: Japanese
  • Other relevant demographics: Not reported
  • Anthropometrics: Mean BMI was 26.8±3.7kg/m2 in the Single Guidance Group and 27.2±3.4kg/m2 in the Multiple Guidance Group. There were no significant differences between groups at baseline.
  • Location: Preventive Medical Center, Tohoku Rosai Hospital, Sendai, Japan.
Summary of Results:

Key Findings

  • Body weight and waist circumference were significantly reduced and liver function, lipid profiles and glucose metabolism were significantly improved in both groups
  • After six months, body weight was significantly reduced in both groups (-2.5±4.7kg, P<0.0001 in the Single Guidance Group; -4.1±4.6kg, P<0.0001 in the Multiple Guidance Group), as well as waist circumference (-1.9±5.7cm, P<0.005 in the Single Guidance Group; -4.8±5.6cm, P<0.0001 in the Multiple Guidance Group)
  • After six months, there were significant reductions in triglycerides (-21±77mg/dL, P<0.01 in the Single Guidance Group; -35±67, P<0.005 in the Multiple Guidance Group) and significant increases in HDL (2.4±7.7mg per dL, P<0.05 in the Single Guidance Group)
  • After six months, glucose metabolism was significantly improved in both groups, with decreases in fasting blood sugar (-9.0±14.0mg per dL, P<0.0001 in the Multiple Guidance Group) and HbA1c (-0.12±0.35, P<0.005 in the Single Guidance Group; -0.23±0.38, P<0.001 in the Multiple Guidance Group)
  • After six months, there was only a significant decrease in systolic blood pressure in the Multiple Guidance Group (-4.9±14.0mmHg). There were no significant changes in diastolic blood pressure in either group.
  • After adjustment for baseline data, the Multiple Guidance Group showed considerably higher reduction in waist circumference (-1.9±5.7cm vs. -4.8±5.6cm, P=0.02) and fasting blood sugar concentration (-2.5±14.1mg vs. -9.0±14.0mg per dL, P =0.03) than the Single Guidance Group.
Author Conclusion:
  • In conclusion, this study showed that additional repeated counseling improved the anti-diabetic effects of single individualized lifestyle guidance in metabolic syndrome
  • This data supports the Japanese government's strategy that legally requires metabolic syndrome patients to receive repeated lifestyle guidance.
Funding Source:
University/Hospital: Preventative Medical Center, Japan
Reviewer Comments:

The authors noted several limitations to the study.

  • First, the number of anticipated subjects was not gathered, so this may have lowered the power to discriminate the health effects between the Multiple Guidance and the Single Guidance Groups
  • Second, the study period was only six months long, therefore its long-term effects are unclear.
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? No
  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? N/A
  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? Yes
  6.6. Were extra or unplanned treatments described? Yes
  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? N/A
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)? N/A
  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? Yes
  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