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MNT: Weight Management (2015)

Citation:

Holmes AL, Sanderson B, Maisiak R, Brown A, Bittner V. Dietitian services are associated with improved patient outcomes and the MEDFICTS dietary assessment questionnaire is a suitable outcome measure in cardiac rehabilitation. J Am Diet Assoc. 2005; 105(10): 1533-1540.

PubMed ID: 16183352
 
Study Design:
Cohort study.
Class:
B - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:

The purposes of this study were to:

  • Examine the effectiveness of Registered Dietitian (RD) educating and counseling on diet-related patient outcomes compared with general education provided by the cardiac rehabilitation staff
  • Evaluate the effectiveness of the Meats, Eggs, Dairy, Fried Foods, In Baked Goods, Convenience Foods, Table Fats, Snacks (MEDFICTS) score as an outcome measure in cardiac rehabilitation.
Inclusion Criteria:

Patients with coronary heart disease who completed cardiac rehabilitation between January, 1996 and February, 2004.

Exclusion Criteria:
  • Nonischemic cardiac diagnoses (N=30)
  • Multiple admissions (N=24)
  • Incomplete MEDFICTS data (N=11).
Description of Study Protocol:

Recruitment

Observational study data on patients discharged between January, 1996 and February, 2004. Data for this study were abstracted from the Cardiac Rehabilitation Program outcomes database at the University of Alabama at Birmingham. 

Design

Cohort study.  

Intervention

Sessions included a combination of telemetry-monitored exercise, individual counseling and group education classes.

An initial orientation and assessment appointment was conducted by a case manager (registered nurse or exercise physiologist). A typical program involved 24 to 36 prescribed sessions two to three times per week within three to four months.

Individual counseling by RD was not routinely practiced for all patients, but it was recommended to supplement the group education classes when indicated.

Groups were formed based on education source:

  • Registered Dietitian
  • General education from cardiac rehabilitation staff.

Statistical Analysis

  • Baseline characteristics were compared between groups with T-tests or chi-square tests
  • Pre- and post-diet-related outcomes were compared within groups with paired T-tests
  • Controlling for baseline measures and lipid-lowering medication, associations were examined between RD education and diet-related outcomes and ending MEDFICTS score and diet-related outcomes.

 

Data Collection Summary:

Timing of Measurements

Data extracted from outcomes database.

Dependent Variables

  • Lipids
  • Waist circumference measured around the largest part of the abdomen in inches
  • Height, weight, body mass index (BMI) measured on scale without shoes 
  • MEDFICTS score
  • Self-reported physical activity of minutes engaged in moderate or vigorous activities lasting for at least 10 minutes duration.

Independent Variables

Groups were formed based on education source:

  • Registered Dietitian
  • General education from cardiac rehabilitation staff.

Control Variables

  • Age
  • Ethnicity
  • Cardiovascular risk factors
  • Lipid-lowering medication
  • Baseline measurements.
Description of Actual Data Sample:
  • Initial N: 491 patients completed cardiac rehabilitation during January, 1996 and February, 2004
  • Attrition (final N): 426 cardiac rehabilitation patients (30% female) after application of exclusion criteria. 359 received RD education, 67 received general education.
  • Age: Mean age 62±11 years
  • Ethnicity: 28% were non-White
  • Location: University of Alabama at Birmingham.

 

Summary of Results:

Diet-related Measures Compared Before and After Cardiac Rehabilitation

Variables

RD Education - Change (N=359)

Within Group P Value

General Education - Change (N=67)

Within Group P Value Between Groups P Value for Change

Total Cholesterol

-17.9±49 <0.001 -17.9±41 NS NS

LDL-Cholesterol

-17.1±42

<0.001

-6.0±34

NS 0.06
HDL-Cholesterol +0.5±8 NS  +1.0±6 NS NS
Triglycerides -34.4±165 <0.001 -9.2±121 NS NS
Waist, Inches -0.6±2 <0.001 0±2 NS 0.03
BMI -0.4±1 <0.001 -0.2±1 NS NS

MEDFICTS Diet Scores

-13.8±27

<0.001

-8.5±18

<0.001 NS

Other Findings

84% of patients received some aspect of RD education, and those receiving the most intensive RD education had baseline MEDFICTS scores indicating the poorest diet habits and achieved the greatest degree in improvement in dietary scores. 

At baseline, the RD group had more dyslipidemia (88% vs. 76%), more obesity (47% vs. 27%), a larger waist (40±6 vs. 37±5 inches), a higher BMI (30±6 vs. 27±5), a higher diet score (32±28 vs. 19±19) and lower self-reported physical activity (7±12 vs. 13±18 metabolic equivalent hours) than the general education group (all P<0.05).

RD education was associated with improved LDL-cholesterol (R=0.13, P=0.04), triglycerides (R=0.48, P=0.01), and MEDFICTS score (R=0.18, P=0.01).

Improvements in MEDFICTS scores were correlated with improved total cholesterol, triglycerides and waist measurements (all R=0.19; P=0.04). 

Author Conclusion:

RD-facilitated nutrition education and counseling within an outpatient cardiac rehabilitation program was associated with improved diet-related outcomes when compared with patients receiving general education from the cardiac rehabilitation staff. The inclusion of RDs providing nutrition education and counseling is thus an important benefit in cardiac rehabilitation settings. The MEDFICTS diet questionnaire seems to be an effective method of identifying patients at enrollment in cardiac rehabilitation in need of dietary changes that can prompt more intense nutrition education and/or counseling. The MEDFICTS diet score is a responsive and valid measure in cardiac rehabilitation that tracks diet quality changes that ultimately improve diet-related clinical outcomes. Future studies are needed to compare existing dietary behavioral questionnaires or to develop new ones to identify the most effective dietary screening and outcome tool within cardiac rehabilitation settings. Future randomized studies in the cardiac rehabilitation setting are also needed to determine the optimal type and frequency of RD services and other supportive dietary interventions that will optimize patient outcomes.

Funding Source:
Industry:
Morrison Healthcare
Other:
University/Hospital: University of Alabama
Reviewer Comments:

Authors note the following limitations:

  • Single center cardiac rehab program has limited generalizability
  • Data were not collected for the specific purposes of comparing RD-facilitated education and counseling with a control group or testing the effectiveness of the MEDFICTS dietary questionnaire as an outcome measure in a cardiac rehab program.
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? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? No
3. Were study groups comparable? ???
  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? ???
  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? 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.) Yes
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? Yes
  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? 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? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? Yes
  6.6. Were extra or unplanned treatments described? Yes
  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)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? Yes
  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