EAL

PDM: Metabolic Syndrome (2013)

Citation:

Bihan H, Takbou K, Cohen R, Michault A, Boitou F, Reach G, Le Clesiau H. Impact of short-duration lifestyle intervention in collaboration with general practitioners in patients with the metabolic syndrome. Diabetes & Metabolism. 2009; 35: 185-191.

PubMed ID: 19299181

Study Design:

Prospective Cohort Study

Class:

B - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To evaluate the impact of simple, short-term lifestyle interventions on the metabolic syndrome by counseling patients on diet and physical activity according to the objectives of the French National Food Health Plan (PNNS) guidelines in collaboration with general practitioners (GPs) .

Inclusion Criteria:

Patients attending the Health Testing Center for a global health examination were screened for metabolic syndrome, including laboratory tests
Of 4,511 consultations given over five months, 3,250 subjects underwent a blood test, 386 (11.8%) of whom were found to have metabolic syndrome
95 consecutive patients who returned for their results and agreed to participate in the study.

Exclusion Criteria:

Diabetic patients or those taking hypolipidaemic therapy were excluded.

Description of Study Protocol:

Recruitment

Patients attending the Health Testing Center (CES) for a global health examination and who were screened for metabolic syndrome.

Design

Prospective cohort study

Blinding used

Implied with measurements

Intervention

A medical face-to-face interview was scheduled 15 days after screening for the metabolic syndrome, and all of the study patients received a planned intervention consisting of education, phone calls and re-evaluation after six months
- Subjects were classified as having the metabolic syndrome (MS) based on the National cholesterol Education Program Adult Treatment Panel III
- Anthropometric measures, blood pressure, blood lipids and blood glucose measures were collected at baseline and at six months post-intervention
- A baseline questionnaire on nutrition habits, physical activity, PNNS objectives and deprivation status, plus the subject's psychological profiles were assessed
- The subject's eating habits and physical activity were then compared to their results with the nine objectives of the PNNS guidelines; for each item, the subject was identified as being either compliant or not
- At six months, each subject repeated the biological and clinical data, which was then compared to the results from the baseline data collected
Baseline Medical Face-to-Face Interview:
- A single practitioner conducted the interviews lasting from 15 minutes to one hour
- Focus was on MS and its probable consequences on health, plus the management of MS with lifestyle modification
- Two documents were provided in accordance with the PNNS recommendations
- The documents were to be passed on from the subject to their general practitioner (GP)
- The results of the examination (clinical and biological data) were sent to the subject's GP and the subjects were encouraged to consult their GPs during the following two months as a specific follow-up
At three months, a CES practitioner contacted all the GPs by phone to evaluate follow-up of their patients as well as to obtain the GPs' opinions of the importance of the MS and the implications of their attitude in their daily practice, counseling and treatments
- This call also encouraged and promoted interaction between the GP and his patient
- The subject was also called by the CES practitioner to reinforce the educational message regarding MS.

Statistical Analysis

Descriptive statistics were used to describe the data
Odds ratios were conducted
Two-sided T- and McNemar tests were used to analyze the differences between the groups at baseline and at six months post-intervention.
Logistic-regression analysis was conducted.

Data Collection Summary:

Timing of Measurements

Baseline and six months post-intervention

Dependent Variables

Modifications in eating and exercise behaviors in accordance with the PNNS objectives
Anthropometric measures
Blood lipids
Blood glucose
Blood pressure.

Independent Variables

Education on nutrition and physical activity in accordance with PNNS guidelines and in collaboration with GPs.

Control Variables

Description of Actual Data Sample:

Initial N

N=95

46 males
49 females.

Attrition (Final N)

N=82; (N=2 excluded with diabetes; N=11 lost to follow-up).

Age

52±4.5 years.

Ethnicity

French.

Other Relevant Demographics

Employment status: 70.7% of males, 38.1% of females
Those who had a GP: 68.4% of males; 93.3% of females
State of deprivation (>40.2) score: 54.3% of males; 63.3% of females.

Anthropometrics

Anthropometric measures were similar within the subject population.

Location

Bobigny, France.

Summary of Results:

Key Findings

N=43 (52.4%) of the 82 subjects still had MS after the intervention
The main positive outcomes were seen in SBP (-30.5%; median BP: -8.89mmHg), waist circumference (-29.3%) and triglyceride levels (-22.0%) in both genders
Percentage of subjects achieving PNNS goals in modifications of nutritional and physical behaviors from baseline to six months post-intervention (N=81, except for physical activity, N=78. Some questions were left unanswered).
After six months, median weight had decreased from 90.1±13.7 to 88.4±13.0kg in men and from 84.2±16.9 to 83.1±16.0kg in women
There were no significant changes in HDL-cholesterol and blood glucose levels.

Objective	Baseline	Six months	Chi-square (P<0.05)
Fruit/Vegetables	3.7%	12.3%	0.039
Added fats	80.3%	91.3%	0.022
Added sugar	49.4%	91.4%	0.000
Beverages	22.2%	63.0%	0.000
Physical activity	6.4%	26.9%	0.001

Author Conclusion:

The authors concluded that simple healthcare measures integrated with GP practices, together with external help for therapeutic education and counseling, may be as effective as more time-consuming lifestyle modification interventions.

Funding Source:

Other:

Source was not identified

Reviewer Comments:

The authors misrepresented the number of subjects (N=43 of 82, 52.4%) who had a decrease in MS in the abstract and in the text of the article. The article stated that N=43 still had MS, however 52.4% experienced a decrease in the prevalence of MS. Actually N=39, 47.6% experienced a decrease in MS.
The results were somewhat unclear and difficult to understand because not enough statistical information was provided
Often ANOVA is used as a statistical test for repeated measures, which would have been appropriate in this study as well, however, it was not used in the analysis of the data.

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?	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?	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?	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?		???
	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?	???
	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?	???
	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?		???
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	???
	8.2.	Were correct statistical tests used and assumptions of test not violated?	???
	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?		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?		???
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.2.	Was the study free from apparent conflict of interest?	???