EAL

MNT: Disorders of Lipid Metabolism (2015)

Citation:

Makrilakis K, Grammatikou S, Liatis S, Kontogianni M, Perrea D, Dimosthenopoulos C, Poulia KA, Katsilambros N. The effect of a non-intensive community-based lifestyle intervention on the prevalence of metabolic syndrome. The DEPLAN study in Greece. Hormones. 2012; 11(3): 316-324. PubMed ID: 22908064

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 evaluate the impact of a one-year, non-intensive, community-based, lifestyle intervention program for the prevention of type II diabetes (T2D), on the prevalence of metabolic syndrome (MS) in individuals at high risk for developing T2D.

Inclusion Criteria:

Completion of the Finnish Type II Diabetes Risk Score (FINDRISC) questionnaire with results that individual was at high risk (FINDRISC sore higher than 15) for T2D
Aged 35 years to 75 years
Resided or worked in metropolitan area around Athens
Normal standard oral glucose tolerance test results (OGTT)
Written, informed consent.

Exclusion Criteria:

Diabetes diagnosis.

Description of Study Protocol:

Recruitment

Recruited from primary care and occupation settings.

Design

In accordance with the FINDRISC score, high-risk persons for T2D participated in a one-year lifestyle intervention program consisting of six one-hour bi-monthly group sessions with a dietitian. MS prevalence was assessed at baseline and one year later.

Intervention

Six one-hour group-based (six to 10 people) sessions held monthly by a dietitian in the area of the participants' residence or work.

Statistical Analysis

Normality of distributions evaluated with Kolmogorov-Smirnov test
Comparisons between normally distributed continuous variables were performed with the calculation of paired samples Student's T-test
Non-normally distributed variables were carried out with Related Samples Wilcoxon Signed Rank test
Association between categorical variables were tested with the use of contingency tables and calculation of chi-squared test
Pearson's correlation coefficient was used to investigate associations between variables
Multiple logistic regression analysis
P<0.05 was significant.

Data Collection Summary:

Timing of Measurements

Taken at baseline and one year after intervention:
- Fasting and two-hour glucose obtained from standard 75g OGTT
- Blood pressure with average of two measurements used
- Body weight and height
- Body mass index (BMI) calculated
- Waist circumference
- Lipid panel including total cholesterol, triglycerides, HDL-cholesterol and LDL-cholesterol
- Dietary assessment using semi-quantitative FFQ
- Presence of MS assessed based on the revised AHA/NHLBI definition.
Questionnaire regarding socio-demographic characteristics and nutritional, physical activity and smoking habits completed at baseline and one year after intervention

Dependent Variables

Presence of MS
Fasting and two-hour glucose
Blood pressure
Body weight and height
Body mass index (BMI) calculated
Waist circumference
Lipid panel including total cholesterol, triglycerides, HDL-cholesterol and LDL-cholesterol
Dietary assessment
Physical activity.

Independent Variables

One-year intervention program consisting of six group-based sessions conducted by a registered dietitian.

Control Variables

Socio-demographic characteristics
Smoking habits
Age
Gender.

Description of Actual Data Sample:

Initial N: N=191 subjects (60% females, 40% males)
Attrition (final N): N=125 subjects
Age: Age 56.3±10.8 years.

Anthropometrics

Prevalence of MS was similar across all age groups and genders
Significant differences by age group emerged for the prevalence of high BP (increasing with age, P<0.001) and for the prevalence of high waist circumference and low HDL-cholesterol for the two genders (both higher in women).

Location

Athens, Greece.

Summary of Results:

Key Findings

Prevalence of MS at baseline was 63.4±48.4% and decreased to 54.8±50% at the end of intervention (P<0.001)
High waist circumference was the most common component (82% of participants)
Severity of MS in terms of the number of positive criteria did not differ by age groups or gender:
- 40.7% of subjects had three positive criteria
- 19.% of subjects had four positive criteria
- 3.3% of subjects had all five positive criteria.
In a multiple logistic regression model with backward selection of variables, including the variables that showed significant correlations in the univariate analyses; younger age (beta=–0.16, P=0.009), male gender (beta=4.44, P=0.004), improvement in dietary score after one year (beta=3.34, P=0.022), lower FINDRISC score (beta=–0.67, P=0.033), lower triglyceride level (beta=–10.12, P=0.01) and a higher HDL-C level (beta=0.32, P=0.003) were significantly and independently associated with improvement in MS status.

Variables	Baseline	One Year After Intervention	P-value
Weight (kg)	89.1 (13.4)	88.1 (13.6)	0.025
BMI (kg/m²)	32.1 (4.2)	31.6 (4.0)	0.015
Waist circumference (cm)	103 (11)	102.7 (10.6)	0.599
Systolic BP (mm Hg)	129.8 (15.8)	126.7 (18)	0.029
Diastolic BP (mm Hg)	78.8 (11.4)	79.9 (10.5)	0.361
Glucose fasting (mg per dL)	104.7 (11.3)	103.9 (24.1)	0.699
Glucose two hours (mg per dL)	118.4 (32.3)	122.2 (52.2)	0.384
Total cholesterol (mg per dL)	228.1 (34.1)	214 (36.9)	<0.001)
Triglycerides (mg per dL)	112	109.5	0.857
HDL-C (mg per dL)	49.8 (8.5)	49.8 (8.2)	0.925
LDL-C (mg per dL)	154.2 (30.5)	139.4 (35.4)	<0.001
Intervention dietary score	15.8 (2.9)	16.6 (3.1)	0.003
Exercise at work and leisure (minutes per day)	37.2 (28.3)	34.1 (25.8)	0.325
MS (percent)	63.4 (48.8)	54.8 (50)	<0.001

Other Findings

All subjects attended at least one intervention session with the dietitian:

9.7% attended one session
4.0% attended two sessions
12.9% attended three sessions
12.1% attended four sessions
26.6% attended five sessions
34.7% attended all six sessions.

Author Conclusion:

The prevalence of MS in middle-aged persons at high risk for the development of T2D is quite high and a one-year, non-intensive lifestyle intervention program is able to decrease MS prevalence significantly, possibly conferring multiple cardiovascular health benefits.

Funding Source:

Government:

Commission of the European Communities, Directorate C Public Health Grant

Reviewer Comments:

High attrition (35%) at one year
Author noted limitations:
- Small sample size
- Short duration (one year)
- Lack of control group.

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?		N/A
	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?	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	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?	Yes
	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?	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?	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?	No
	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?	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)?	No
	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?		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