HTN: Medical Nutrition Therapy (2015)


Ferrara AL, Pacioni D, Di  Fronzo V, Russo BF, Stalano L, Speranza E, Gente R, Gargiulo F, Ferrara F. Lifestyle educational program strongly increases compliance to nonpharmacologic intervention in hypertensive patients: A two-year follow-up study. J Clin Hypertens. 2012; 14(11): 767-772. 

Study Design:
Randomized Controlled Trial
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:
To evaluate whether an educational program dedicated to non-pharmacologic measures to treat hypertension, including small group meetings with doctors and dietitians in addition to usual controls in the outpatient clinic, would be useful in achieving better and long-lasting results in the control of blood pressure (BP) levels, body weight (BW) and serum parameters of glucose and lipid metabolism when compared with the usual approach in an outpatient clinic. 
Inclusion Criteria:
Stable blood pressure for the previous six months.
Exclusion Criteria:
Normal blood pressure.
Description of Study Protocol:


Hypertension outpatient clinic.



Blinding Used

Doctors and dietitians in the outpatient clinic were unaware of the group to which patients were randomized.


Educational care program (EC) or usual care (UC). Those in EC were supplemented with additional information regarding the disease and importance of non-pharmacologic treatment per a protocol of small group meetings with a dietitian and doctors.
All received UC, which included visits every three months in outpatient clinic with a physician and an RD.


Comparison of means were performed by Student T-test for unpaired data and one-way analysis of variance with Tukey's multiple comparisons. Non-parametric variables were analyzed by X2 test.


Data Collection Summary:

Timing of Measurements

Baseline and one year, as well as a measurement at year two for a sub-sample that agreed to continue.

Dependent Variables

  • BP, heart rate
  • BW, BMI
  • Blood lipids, serum creatinine, fasting blood glucose.

Independent Variables

Educational care vs. usual care programs.

Control Variables

Mediterranean diet low in salt.

Description of Actual Data Sample:
  • Initial N: N=200
  • Attrition (final N): N=188 (98 males, 90 females)
  • Age: Aged 56.2±10 years
  • Anthropometrics: Similar for BW, BP, glucose, lipids, energy intake, dietary macronutrients and micronutrients, smoking history, physical activity and daily anti-hypertensive use
  • Location: Naples, Italy.


Summary of Results:


  • Between-group differences in BMI (P<0.001), visceral obesity (P<0.001), systolic BP (P<0.001), diastolic BP (P<0.01) and triglycerides (P<0.01) were found at one year, with EC having lower values
  • Between baseline and 12 months, EC had significant decreases in SBP and DBP (P<0.001), waist circumference (P=0.04), cholesterol (P=0.01)  and LDL-C (P=0.02)
  • At two years, differences between EC (N=59) and UC (N=56) remained for BW (P<0.05), BMI (P<0.01), waist circumference (P<0.001), SBP (P< 0.01) and DBP (P<0.03)
  • No significant changes occurred in anti-hypertensive therapy in either group. 
  • Changes in systolic BP during follow-up were significantly related to changes in BW, BMI, energy intake, lipids (particularly saturated fatty acids), cholesterol and sodium. 
Author Conclusion:
The present investigation shows that involving patients in a face-to-face program with doctors and dietitians is a low-cost and benefit procedure able to improve the outcome of the disease and reduce the risk of cardiovascular events, possibly preventing increasing costs for drug therapy.
Funding Source:
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) No
  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? 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? 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? No
  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? 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? 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? 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)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? N/A
  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