EAL

MNT: Disorders of Lipid Metabolism (2015)

Citation:

Batista MdCR and Franceschini SdCC. Impact of nutritional counseling in reducing serum cholesterol in public health service patients. Arq Bras Cardiol. 2003; 80 (2):167-170.

PubMed ID: 12640510

Study Design:

Before-After Study

Class:

D - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To assess the impact of nutritional counseling on lipid profiles of hypercholesterolemic patients treated at basic health units and to assess patients' nutritional status before and after this intervention.

Inclusion Criteria:

Over 20 years of age
Total serum cholesterol at least 200mg per dL
Had received dietary counseling and returned at least once to consult with nutritionist
Had not used lipid-lowering medication during study period.

Exclusion Criteria:

Diabetics
Those with CAD.

Description of Study Protocol:

Recruitment: Patients with hypercholesterolemia were referred by health care workers for nutritional guidance and studied at two basic health units
Design: Before-after study
Intervention: Dietary counseling (instructions for food selection, portion size and preparation provided after a dietary recall). Adjusting total fat, saturated fat and cholesterol and trans fat intake, increasing fiber intake, according to NCEP 1993.
Statistical analysis: Medians were compared using Wilcoxon test; frequencies compared using chi-square test. P<0.05 as significance level.

Data Collection Summary:

Timing of Measurements

Initial screening (baseline), follow-up at three months, then final screening (varied, median time 11 months after baseline).

Dependent Variables

BMI
Total, LDL- and HDL-cholesterol
Triglycerides.

Independent Variables

Dietary counseling (all received).

Control Variables

Not reported, aside from "intervention" description.

Description of Actual Data Sample:

Initial N: 96; 86.5% female, 13.5% male
Attrition (final N): Not described
Mean age: 53.2±12 years; 68.8% 59 years of age or younger and 31.3% over 60 years)
Ethnicity: Not described
Other relevant demographics: Not described
Anthropometrics: 70.3% overweight or obese
Location: Belo Horizonte, Brazil.

Summary of Results:

Key Findings

Variables (from Figure 1)	Before 3 Months of Dietary Intervention Mean (no SD provided)	After 3 Months of Dietary Intervention Mean (no SD provided)	Statistical Significance of TIme Effect
BMI	27.8	27	P<0.001
Total Cholesterol	263.5	239.5	P<0.001
LDL-Cholesterol	175	149	P<0.001
Triglycerides	187	150	P<0.05

No change in HDL (P=0.78).

Author Conclusion:

Dietary intervention provides significant improvement in the lipid profile of patients and should be employed as a primary treatment for hypercholesterolemia.

Funding Source:

Other:

not reported

Reviewer Comments:

Not specified; all variables differ
Attrition is uncertain (BL-EP)
Many counfounders not described.

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?		???
	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?	No
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
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?		No
	4.1.	Were follow-up methods described and the same for all groups?	No
	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%.)	No
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	No
	4.4.	Were reasons for withdrawals similar across groups?	???
	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?	???
	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.)	???
	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?	???
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		N/A
	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?	No
	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?	No
	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?	N/A
	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?	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?		No
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	No
	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?	No
	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?	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?		No
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	No
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?	Yes