MNT: Disorders of Lipid Metabolism (2015)
Gaetke LM, Stuart MA, Truszczynska H. A single nutrition counseling session with a registered dietitian improves short-term clinical outcomes for rural Kentucky patients with chronic diseases. J Am Diet Assoc. 2006 Jan; 106(1): 109-112.PMID: 16390674PubMed ID: 16390674
To determine if nutrition counseling from a Registered Dietician (RD) would improve clinical outcome measures of patients with type 2 diabetes and (CVD) on a subsequent physician visit.
Subjects must be:
- Adult patients and selected subjects seen by the same MD between 1991 and 2002 in a rural outpatient office in small eastern Kentucky town
- Diagnosed with Type 2 diabetes mellitus (DM) or CVD
- Referred to the same RD by the physician.
Subjects were excluded if they were:
- Diagnosed with additional major medical complications
- Taking lipid-lowering or hypoglycemic agents.
No recruitment, this was a medical record review.
Retrospective cohort study
- One-hour individual diet instruction by RD who provided and explained written materials
- RD met with patient either on the same day or within a three-week period.
- Baseline characteristics compared between medical nutrition therapy (MNT) group and group not receiving MNT using two sample T-tests or Χ2 tests of association
- Mean clinical outcomes were compared using two-way repeated measures analysis of variance:
- Within subjects at baseline and three months
- Between subjects (MNT compared to non-MNT)
- BMI measures using whole sample (N=175)
- Disease-specific measures done for CVD (N=94) and Type 2 DM (N=94) separately, sample sizes varied due to missing data
- Post-hoc comparison of means done by comparing change in outcome measures over a three-month (baseline to follow-up) within groups
- Mean clinical outcomes adjusted by age and sex.
Timing of Measurements
- Clinical and anthropometric measures abstracted from medical records at a baseline MD visit before seeing the RD (if seen)
- Second measures collected from chart at a second MD visit three months after scheduled nutrition counseling.
- Clinical outcome measures:
- Fasting blood glucose
- TC, LDL, HDL, TC/HDL, TG
- Anthropometric Measures
- Body weight
Single RD patient visit.
- 58 females, 117 males.
- Mean age: 60 years
- Age range: 32 to 90 years.
- MNT group was significantly younger than non-MNT group (57.6±12.0 years vs. 63.0±12.4 years, P=0.004)
- MNT group had a HbA1c significantly higher than non-MNT group (9.8%±2.5% vs. 8.4%±1.7%, P=0.02)
- MNT group did not differ significantly in gender compared to non-MNT group
- MNT group were more likely to use tobacco than non-MNT group (38.1% vs. 18.2%, P<0.04).
Small rural eastern Kentucky town.
Baseline (Adjusted for Age and Sex)
Measures and Confidence Intervals
Three-month Visit (Adjusted for Age and Sex)
Measures and Confidence Intervals
Mean fasting blood glucose (mmol per L)
|Mean HbA1c (%)|
|Mean TC (mmol per L)|
|6.4±0.1||6.6±0.1||Not significant, only significant difference seen for unadjusted values|
|Mean LDL (mmol per L)|
|Mean TG (mmol per L)|
|Body weight (lbs)|
|Variables||MNT Group||Non-MNT Group||Significance|
Fasting blood glucose
(ADA target, <7.0 mmol per L)
Met target at three months
(ADA target, <7%)
Met target at three months
|20 (N=44)||0 (N=44)||P<0.01|
(NCEP target, <5.17 mmol per L )
Met target at three months
|8 (N=45)||0 (N=43)||P<0.01|
- MNT and non-MNT groups not significantly different at baseline for number of patients meeting targeted guidelines for fasting blood glucose, HbA1c, or TC
- A convenience subsample of the study population (MNT group = 43, non-MNT group = 19) was analyzed for length of time outcomes measures remained significantly different from baseline:
- Outcomes that were significantly different at three months were still significantly different at six months
- Outcomes that were significantly different at three months had returned to baseline values at 12 months.
- Patients with chronic diseases, including type 2 diabetes and CVD, who receive a single nutrition counseling session with an RD had improved clinical outcome measures compared with patients with the same chronic diseases who did not receive nutrition counseling.
- Continued need for RD visits after six months based upon small convenience sample of study population
- Confirms value of nutrition intervention as an effective approach to treating type 2 diabetes and CVD.
|University/Hospital:||University of Kentucky Summer Faculty Research Fellowship Program|
- Body weight is mislabeled in the table. It is defined as kilograms and it should be pounds.
- No statistical explanation of patients with missing data
- Provides adjusted measures for age and sex, although gender was not statistically different between groups
- No control for confounding factors that play a role in disease outcomes, such as tobacco use or ethnicity
- Unclear as to why statistical comparisons were not made between groups (MNT vs. non-MNT) with continuous clinical outcome data, only with nominal data
- No explanation of records not included in final sample size.
Quality Criteria Checklist: Primary Research
|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|
|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?||No|
|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?||No|
|3.||Were study groups comparable?||No|
|3.1.||Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)||No|
|3.2.||Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?||No|
|3.3.||Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)||No|
|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?||No|
|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")?||No|
|4.||Was method of handling withdrawals described?||N/A|
|4.1.||Were follow-up methods described and the same for all groups?||N/A|
|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%.)||N/A|
|4.3.||Were all enrolled subjects/patients (in the original sample) accounted for?||N/A|
|4.4.||Were reasons for withdrawals similar across groups?||N/A|
|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?||No|
|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.)||No|
|5.3.||In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?||No|
|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?||No|
|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?||No|
|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?||N/A|
|6.8.||In diagnostic study, were details of test administration and replication sufficient?||Yes|
|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?||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)?||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?||No|
|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|