EAL

DLM: Medical Nutrition Therapy (2010)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

This study evaluated the incremental value of detailed nutritional counseling by dietitians when added to general nutritional advice provided by physicians.

Inclusion Criteria:

NCEP criteria for dietary treatment:

LDL cholesterol greater than 4.16mmol per L (Patients with less than two cardiac risk factors)
LDL cholesterol greater than 3.38mmol per L (Patients with greater than two cardiac risk factors)
LDL cholesterol greater than 2.6mmol per L (Patients with CHD or other atherosclerotic CVD).

Exclusion Criteria:

Previous counseling by RD
Unstable cardiovascular condition with the past three years
Pregnancy within previous 12 months
Chronic renal or liver disease
Untreated hypothyroidism or malignancy
Treatment with lipid-lowering drugs, thiazides, estrogen or corticosteroids
LDL cholesterol greater than 5.2mmol per L (200mg per dL)
TG greater than 4.4mmol per L (400mg per dL).

Description of Study Protocol:

Recruitment: participants recruited from cholesterol screening programs in a large industrial complex and from primary care clinics

Design: RCT

Intervention: after a visit with a physician, subjects were randomly assigned to receive further counseling from either a physician or 2-3 individual counseling sessions with a Registered Dietitian during a 3-month period

Data Collection Summary:

Timing of Measurements

Baseline, 6 weeks, 3, 6 and 12 months

Dependent Variables

measured fasting lipid profiles (total cholesterol, triglycerides, HDL- cholesterol) and used Friedwald method to calculate LDL-cholesterol

Independent Variables

Usual care by physician
MNT by Registered Dietitian (2-3 individual sessions in 3 month period) after initial visit with physician

Description of Actual Data Sample:

Initial N: 136 (66 to dietitian group; 70 to physician group)

Attrition (final N): 118 (13% attrition rate; 8 subjects dropped out of each group)

Anthropometrics Baseline: no differences in lipids, weight, BMI, activity levels or diet betweeen treatment groups

Location: Israel

Summary of Results:

Changes in total were greatest at 3 months when subjects in the dietitian counseling group had greater significantly greater percent change in total cholesterol than the physician group of -9±8% versus -5±9% (95% CI 1-7%), respectively (P<0.05). Mean decrease in the LDL-cholesterol was 12±10% in the RD group and 7±11% the physician's usual care group (P<0.0004). Only 40% of subjects had reached NCEP goal by end of 3 months. By 12 months, serum lipids for both groups of subjects had climbed and about half the benefit had been lost.

Author Conclusion:

The results of this study can help refine the dietary approach to the treatment of patients with hypercholesterolemia
Dietary counseling by primary care practitioners and dietitians in “ a stepped approach” may be appropriate, especially if strategies for enhancing long term adherence are developed.
Patients at higher risk are less likely to attain the specified target goals with the current NCEP diets alone, even when counseled by registered dietitians
A modified dietary approach possibly combined with earlier introduction of lipid lowering medications should be considered in these patients.

Funding Source:

University/Hospital:

Faculty of Medical Sciences, Ben-Gurion University, Beer-Sheva, Israel

Reviewer Comments:

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?	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?	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?	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)?	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