EAL

MNT: Disorders of Lipid Metabolism (2015)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To determine the extent to which 2 types of counseling (Individual vs. Group) can improve physical profiles and metabolic disorders in patients with metabolic syndrome.

Inclusion Criteria:

Metabolic syndrome diagnosis.

Exclusion Criteria:

Malignant diseases
Inflammatory diseases
History of CVD
Virus or autoimmune hepatitis
Cirrhosis
Renal diseases
Thyroid diseases
Arthropathy
Other physical problems
Medication-treated diabetes mellitus
Dyslipidemia
Primary or secondary hypertension.

Description of Study Protocol:

Recruitment: Employee health checkup at the workplace
Design: Those with metabolic syndrome diagnoses were randomized into one of two groups; Individual Couseling or Group Counseling
Intervention
- Individual Counseling (IC): Three-day diet record analyzed by RDs; patients given personalized counseling sessions (one hour) plus four one-hour general counsultations with healthcare workers (MDs and RNs)
- Group Counseling (GC): One-hour group session on fundamental dietary advice by RDs plus four one-hour general consultations with healthcare workers.
Statistical analysis: Student's T-test, Peason's chi-square; P<0.05 as significant.

Data Collection Summary:

Timing of Measurements

Group session or individual session by RD at baseline only.

Dependent Variables

Body weight, body fat percentage, waist circumference measured at baseline and monthly
Blood sampling (glucose, insulin, Hgb A1C, TG, cholesterol) measured at baseline and three months.

Independent Variables

RD Counseling Group.

Control Variables

Timing of measurements
Health worker contact.

Description of Actual Data Sample:

Initial N

161 males recruited
37 randomized to individual counseling (IC) and 54 to group counseling (GC).

Attrition (Final N)

IC: 37
GC: 54
0% attrition rate.

Age

IC: 51.1±6.4 years
GC: 49.6±5.0 years.

Ethnicity
Japanese.

Anthropometrics
BMI

IC: 27.3±2.1kg/m²
GC: 27.6±2.3kg/m².

Location
Kobe, Japan.

Summary of Results:

Key Findings
Change in parameters (from baseline to three months) between IC and GC were each significantly greater in the IC than in GC.

Change in BMI: -0.6kg/m²
Body fat percentage: -2.5%
Waist circumference: -2.2cm
Systolic BP: -3.3mmHg
LDL-cholesterol: -7.9mg/dL
HbA1c: -0.7%.

While both types of counseling were somewhat effective, these results suggest that IC led to greater improvement in these metabolic outcomes.

Author Conclusion:

Lifestyle diet and exercise counseling, especially individually, may improve physical profiles and metabolic disorders in patients with metabolic syndrome.

Funding Source:

Other:

No Funding Disclosed.

Reviewer Comments:

Only one visit with RD in both IC and GC Groups: It is questionable whether this represents enough exposure.

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?	N/A
	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)	No
	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?		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?	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?	???
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	No
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	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?	N/A
	7.7.	Were the measurements conducted consistently across groups?	N/A
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?	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