MNT: Disorders of Lipid Metabolism (2015)
Recruitment
Included subjects had abnormal laboratory findings (hypertension, diabetes, dyslipidemia, abnormal liver function indices) among employees of L Company who received a health examination and a comprehensive medical checkup implemented by the National Health Insurance Workplace visiting nutrition education program between June and September 2011.
Design
Cohort study.
Intervention- Male workers received nutrition education by a clinical dietitian for four months:
- Clinical nutritionists visited the workplace to provide nutrition assessment and education and to observe the progress of subjects every month
- Each educational session was carried out for 20 minutes and subjects received consulting two times on average
- Self-developed nutrition education leaflets were used as educational tools.
- Anthropometric data (height, weight, waist circumference), blood pressure and biochemical blood indices (fasting blood sugar, liver function tests and total cholesterol panel) were measured before and after the four-month nutrition education period
- Dietary habits and lifestyle (regularity of meals, drinking and smoking habits) were investigated by self-administered questionnaires based on the medical examination chart provided by the National Health Insurance during health checkup
- Nutrient intake was determined by 24-hour dietary recall.
Statistical Analysis
- SPSS Statistic 18 for statistical processing was used
- Descriptive statistics of mean and standard deviation was used to analyze general characteristics
- Non-parametric Wilcoxon signed ranked test of the paired T-test was used to analyze clinical and biochemical measurements including blood pressure, blood lipids, blood glucose and liver function indicators
- Body mass index (BMI) was classified according to normal weight (BMI less than 23.0kg/m2), overweight (BMI between 23.0kg/m2 and 25.0kg/m2) and obese (BMI 25.0kg/m2 or higher) and used the non-sequential variable with the non-parametric method for analysis
- Spearman's correlation was used to verify factors that influence clinical indicators related to metabolic syndrome in the significance level of P<0.05.
Timing of Measurements
Measurements were taken at baseline and again after four months of nutrition education.
Dependent Variables
- Anthropometric measurements taken: Height, weight and waist circumference (WC); BMI was calculated
- Blood pressure: Systolic blood pressure (SBP) and diastolic blood pressure (DBP)
- Blood indices:
- Blood glucose: Fasting blood sugar (FBS)
- Blood lipids: Total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)
- Liver function indicators: Serum glutamic oxalacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and Gamma-glutamyl transpeptidase (r-GTP).
Independent Variables
Four months of nutrition counseling at work.
- Initial N: 75 males
- Attrition (final N): 75 males
- Age: 41.1±5.6 years
- Ethnicity: Korean; not described in detail.
Other Relevant Demographics
Lifestyle and Dietary Habits
Variables | Criteria | N (%) |
Regularity of meals | Yes | 34 (59.6) |
No | 23 (40.4) | |
Alcohol drinking | Drinker | 63 (86.3) |
Non-drinker | 10 (13.7) | |
Smoking status | Smoker | 28 (51.9) |
Non-smoker | 26 (48.1) |
Anthropometrics
Variables | Before Nutrition Education N=75 |
|
Height, cm | 172.2±6.3 | |
Weight, kg | 76.2±10.2 | |
BMI, kg/m2 | 25.7±2.9 | |
Normal weight (BMI<23.0) | 17 (22.7) | |
Overweight (BMI 23.0 to 25.0) | 16 (21.3) | |
Obesity (BMI≥25.0) | 42 (56.0) | |
WC, cm | 88.4±7.7 |
Values are presented as mean±SD or N (%).
Location
Seoul Korea.
Key Findings
Dependent Variables | Independent Variables | Coefficient | P-value |
Blood pressure | |||
SBP, mm Hg | WT, kg | 0.285 | P<0.05 |
DBP, mm Hg | r-GTP, IU per L | 0.240 | P<0.05 |
Glycemic control | |||
FBS, mg per dL | WT, kg | 0.235 | P<0.05 |
BMI, kg/m2 | 0.233 | P<0.05 | |
Lipid profile | |||
TC, mg per dL | TG, mg/dL | 0.270 | P<0.05 |
TG, mg per dL | BMI, kg/m2 | 0.341 | P<0.01 |
r-GTP, IU per L | 0.330 | P<0.01 | |
HDL-C, mg per dL | -0.258 | P<0.05 | |
SGPT, IU per L | 0.272 | P<0.05 | |
HDL-C, mg per dL | WT, kg | -0.240 | P<0.05 |
Liver function indicators | |||
SGPT, IU per L | WT, kg | 0.327 | P<0.01 |
BMI, kg/m2 | 0.259 | P<0.05 | |
r-GTP, IU per L | WT, kg | 0.307 | P<0.01 |
BMI, kg/m2 | 0.255 | P<0.05 |
*Analyzed with Spearman's correlation coefficient.
Other Findings
- Although SBP was reduced from 120.0mm Hg to 117.8mm Hg and DBP was reduced from 79.1mm Hg to 77.0mm Hg after nutrition education there was no significant difference found
- FBS was significantly reduced from 100.5mg per dL to 97.0mg per dL after nutrition education (P<0.01)
- TC was significantly reduced from 211.3mg per dL to 204.4mg per dL (P<0.05)
- TG was reduced from 216.6mg per dL to 204.0mg per dL after nutrition education without showing a significant difference
- HDL-C was similar before and after nutrition education
- LDL-C was significantly reduced from 131.1mg per dL to 123.6mg per dL after nutrition education (P<0.05)
- All liver function tests were reduced after nutrition education but did not present significant difference.
Nutrition intake surveys showed that on subjects consumed:
- 2,160 calories on average (90% of the nutrient intake standards for men between 30 years and 49 years)
- 321.3g carbohydrates (60% total calories)
- 79.7g protein (15% total calories, consisting of 57% animal protein and 43% plant protein)
- 61.8% fat (26% total calories)
- 312.9mg cholesterol (recommendation for dyslipidemia patients is 200mg)
- 15.6g dietary fiber
- 900.7mcg RE vitamin A (recommended intake for men between 30 years and 49 years is 750mcg RE)
- 63.2mg Vitamin C (recommended intake for men between 30 years and 49 years is 100mg).
- The results of this study verified that the visiting nutrition education provided to male workers through individual-based, self-directed education was effective in reducing body mass index and improving clinical quality index
- It is important to achieve nutrition management through systematic education or counseling by nutritionists in the workplace and thus the development of a program suitable for the workplace and the regular implementation of the program is necessary
- It is possible to consider connecting hospitals with professional clinical nutritionists and health check-up programs with workplaces
- Nutritionists will actively contribute to the improvement of national health.
Other: | not described |
- There was no detailed description of how the dependent measurements were taken (e.g., was weight self-reported or measured by nutritionist)
- Data in Table 2 (lifestyle and dietary habits) and Table 7 (average daily nutrients intake) appear to be baseline data. No data were reported after the four months of nutrition counseling.
- No data seem to be collected or reported on exercise, which would influence several of the outcomes
- It is important to note that the BMI categories used in this paper are different that U.S. BMI categories
- The inclusion and exclusion criteria was not described in detail. Since no other recruitment methods were described, it appears as if subjects did not have a choice in participating. They were identified based on their abnormal findings on a health exam and participated in the study.
- Had to give a negative rating because there were so many things that were just not described in detail so "unclear" was chosen for many of the answers.
Quality Criteria Checklist: Primary Research
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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? | ??? | |
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? | ??? | |
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) | N/A | |
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.) | ??? | |
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? | Yes | |
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? | N/A | |
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? | N/A | |
5.1. | In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? | N/A | |
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.) | N/A | |
5.3. | In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? | Yes | |
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? | N/A | |
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? | ??? | |
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? | No | |
6.6. | Were extra or unplanned treatments described? | No | |
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? | ??? | |
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? | No | |
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)? | No | |
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? | N/A | |
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? | ??? | |
10.1. | Were sources of funding and investigators' affiliations described? | ??? | |
10.2. | Was the study free from apparent conflict of interest? | ??? | |