PDM: Metabolic Syndrome (2013)

Christian JG, Byers TE, Christian KK, Goldstein MG, Bock BC, Prioreschi B, Bessesen DH. A computer support program that helps clinicians provide patients with metabolic syndrome tailored counseling to promote weight loss. J Am Diet Assoc. 2011; 111(1): 75-83.


PubMed ID: 21185968
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 test the effect of a computerized support tool to enhance brief physician-delivered health lifestyle counseling to patients with increased metabolic risk factors during two usual care visits.

Inclusion Criteria:
  • 18 to 75 years old
  • Waist circumference more than 35 inches for women or more than 40 inches for men or BMI higher than 25kg/m2 and two or more features of metabolic syndrome:
    • TG higher than 150mg per dL
    • HDL less than 40mg per dL for men and less than 50mg per dL for women
    • Fasting glucose of 200mg per dL or higher
    • BP 135/85mm Hg or higher
  • Use of medications to control any of the above.
Exclusion Criteria:
  • Substance use or abuse
  • Severe arthritis or medical conditions limiting physical activity
  • Recent myocardial infarction or stroke
  • Peripheral vascular disease.
Description of Study Protocol:


Clinic staff reviewed records to verify eligibility and contacted, screened and enrolled potential participants sequentially without consideration for their interest in losing weight. 


RCT between two clinics.

Blinding Used

Implied with measurements.


Computer expert system generated four to five page individualized, tailored reports providing feedback addressing participant-identified barriers to improving physical activity and diet. At baseline the subjects brought two to three dietary and physical activity goals they wanted to achieve based on the report. They were then given a 30-page planning guide that provided information on preventing diabetes and achieving dietary and physical activity goals. The computer also provided the patient's physician with a one-page summary of the patient's assessment and provided the physician with patient-specific counseling recommendations based on a motivational interviewing approach. 

Statistical Analysis

Analysis for non-similarity between groups was carried out using hypothesis testing. A one-tail T-test was performed and results were considered significant if there was a less than 5% chance that the variation between groups occurred due to random chance alone.   

Data Collection Summary:

Timing of Measurements

Baseline, six months (intervention only) and 12 months. 

Dependent Variables

  • Height and weight using a digital scale
  • Waist circumference at the superior iliac crest with tape measure parallel to the floor at the end of a relaxed expiration. All measurers were trained by one investigator.
  • BP
  • Fasting blood for glucose, insulin and lipids
  • Physical activity by validated seven-day recall
  • Energy intake by combining the Block and McPherson FFQs.

Independent Variables

  • Computer expert system generated four- to five-page individualized, tailored report providing feedback addressing participant-identified barriers to improving physical activity and diet. At baseline the subjects brought two to three dietary and physical activity goals they wanted to achieve based on the report. They were then given a 30-page planning guide that provided information on preventing diabetes and achieving dietary and physical activity goals. The computer also provided the patient's physician with a one page summary of the patient's assessment and provided the physician with patient-specific counseling recommendations based on a motivational interviewing approach. The subjects had a brief study-related visit at six months to reassess their goals and review their goal sheet with their physician, who reinforced their lifestyle change goals. 
  • The control group was given a packet of health education materials addressing diabetes, diet and exercise before a baseline usual care visit. They had no additional intervention about their specific goals for weight or physical activity other than what they might receive during usual care. 
Description of Actual Data Sample:
  • Initial N: 279 
  • Attrition (final N): 263 (83 males, 180 females)
  • Age: 50.0±11.79 years for controls and 49.2±13.04 years for intervention
  • Ethnicity:
    • 50.8% white, 45.4% Hispanic and 5% other in controls
    • 50.4% white, 42.9% Hispanic and 9% other in intervention
  • Anthropometrics: Similar in sex, economic status, disease risk status, age, weight, BMI, waist circumference, lipids and fasting glucose and insulin.
  • Location: Pueblo, CO.
Summary of Results:

Key Findings

  • Intervention patients lost 1.5kg (1.6% weight change) vs. a mean weight gain of 0.15kg (0.16% weight change for controls (P=0.002)] 
  • 26.5% of intervention sustained a weight loss of 5% or more of total body weight at 12 months vs. 8.5% of controls [OR=3.86; (P=0.002)] and 7.5% sustained a weight loss of 10% or more at 12 months vs. 2,3% of controls [odds ratio=3.4; (P = 0.024)]
  • Intervention had a significant decrease in waist circumference (-2.2cm) vs. a gain in controls (+1.5cm, P=0.01)
  • Baseline BMI, sex, blood serum lipid levels, BP, blood glucose and age did not predict success
  • Intervention increased self-reported physical activity by a mean of 613 metabolic equivalent unit-minutes per week vs. a 123 metabolic equivalent unit-minutes per week for controls (P=0.15)
  • Intervention reduced self-reported energy (kcal) by a mean of 1,495kcal per week (14.9%) vs. a 843kcal per week (6.6%) reduction for controls (P=0.02)
  • No significant differences between the two groups were found for changes in fasting insulin, fasting glucose, TC, LDL-C, HDL-C, TG or systolic and diastolic BP
  • In subjects who lost 5% or more of body weight compared to those who did not, significant differences were found:
    • Change in TC (P=0.03)
    • Change in fasting glucose (P=0.01)
    • Change in TG (P=0.05)
  • No significant differences were found between genders or racial/ethnic groups in any of the outcomes.   
Author Conclusion:

A brief computer-based intervention designed to increase the dialogue between patients and clinicians about behavioral goals can lead to increased 12-month weight loss.

Funding Source:
Government: US National Institute of Diabetes, Digestive and Kidney Diseases
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? 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? 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? 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)? 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? 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