EAL

MNT: Disorders of Lipid Metabolism (2015)

Citation:

Lim H, Son JY, Choue R. Effects of medical nutrition therapy on body fat and metabolic syndrom components in premenopausal overweight women. Ann Nutr Metab. 2012; 61: 47-56.

PubMed ID: 22832546

Study Design:

Before-After Study

Class:

D - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

To examine the effects of MNT on changes of individual metabolic syndrome components
To examine the relationship between metabolic syndrome components and body fat reduction acheived following adherence to an MNT program.

Inclusion Criteria:

BMI of 23kg/m² or higher (WHO cutoff for Asians)
Pre-menopausal women, 20 years of age or older.

Exclusion Criteria:

Diagnosis of any serioius disease, recent surgery, eating disorder, taking any medications during three months prior to the study
Very high knowledge of dietary or lifestyle management, based on nutrition knowledge questionnaire.

Description of Study Protocol:

Recruitment
Community advertisements and websites.

Design
Before-and-after study.

Intervention
An RD provided MNT bi-weekly for 12 weeks (30-minute sessions) according to protocol for MetS management

Program began with assessment of nutritional status and each participant received guidance on calorie needs
Goals: Achieve ideal body weight, avoid high-risk foods and adhere to recommenations (high-quality protein, fiber, vitamins and minerals)
Follow-up interveiws were used to reinforce the intervention.

Statistical Analysis

Paired T-tests to compare changes in variables
Partial correlations controlled for confounding variables used to examine relationship between BF reduction and changes in MetS components
P<0.05 as significance level.

Data Collection Summary:

Timing of Measurements

All measurements of variables of interest collected at baseline and after 12 weeks of MNT intervention.

Dependent Variables

BMI
Body weight
Body fat, kg and percentage
WC
BP
TG
HDL-cholesterol
Fasting glucose
Dietary assessment (collected at baseline and weekly during the 12-week intervention using three-day food records).

Independent Variables

Time and MNT intervention
MetS diagnosis: NCEP-ATPIII and International Diabetes Federation (three or more of the following: WC over 85cm; SBP/DBP over 130/85mmHg, known hypertension or on related therapy; TG at least 150mg per dL; HDL-cholesterol over 50mg per dL; fasting glucose over 100mg per dL, known diabetes or on related therapy.

Control Variables

Age
Duration of physical activity
Alcohol consumption
Cigarette smoking.

Description of Actual Data Sample:

Initial N

291 recruited
172 enrolled.

Attrition (final N)

160
MetS Group: 44
Non-MetS Group: 116.

Age

MetS Group: 39.1 years (range, 28 to 52 years)
Non-MetS Group: 40.3 years (range, 25 to 53 years).

Ethnicity

Korean.

Anthropometrics

BMI

MetS Group: 28.5±3.8
Non-MetS Group: 26.2±2.4.

Location

Seoul, Korea.

Summary of Results:

Key Findings

Mean percentage changes in BF and MetS components following MNT

BF mass declined 11% for both groups (-1.5% and 1.7%)
Change in glucose and SBP/DBP was not different between groups

Changes in the following were significantly different between groups (MetS Group and Non-MetS Group, respectively).

WC: -1.8cm vs. -2.8cm, P<0.05
TG: -42.9 vs. 12.1, P<0.01
HDL: +4.7 vs -2.0, P<0.001.

There were significant associations between changes in body fat percentage and MetS components. In the MetS Group, changes in WC, SBP, DBP and TG were correlated with a BF reduction (P<0.05). In the Non-MetS Group, WC, SBP and DBP were related to change in BF.

Mean kcal intake decreased in both groups and daily fiber intake increased, while dietary cholesterol decreased in both groups (all P<0.05).

Author Conclusion:

Body weight and body fat reduction acheived following an MNT program improved MetS component levels in overweight Korean women
WC, BP and TG levels improved along with BF reduction
Changes in individual MetS components appear to be related to reductions in BF after controlling for covariates
Persistent, tailored intensive MNT for body fat reduction should be used to effectively control metabolic outcomes of pre-menopausal women.

Funding Source:

University/Hospital:

Kyung Hee University Post Doctoral fellowship grant

Reviewer Comments:

No control group used.

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?	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?	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?	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)?	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?	N/A
	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