DM: Effectiveness of MNT Provided by RD/RDN (2015)
Lemon CC, Lacey K, Lohse B, Hubacher DO, Klawitter B, Palta M. Outcomes monitoring of health, behavior, and quality of life after nutrition intervention in adults with type 2 diabetes. J Am Diet Assoc 2004; 104(12):1085-15.PubMed ID: 15565074
To examine changes in health and lifestyle indicators over 6 months in persons with type 2 diabetes mellitus receiving nutrition counseling from a registered dietitian.
A second objective was to promote RD participation in outcomes monitoring and research.
- diagnosis of type 2 diabetes mellitus (DM), regardless of date of diagnosis
- no intervention by a dietetics professional for DM within 1 year of the baseline session
- age 20 years or older
- sufficient cognitive awareness to participate
- acute or chronic renal failure
- chemotherapy or radiation therapy within the previous 60 days
- major unplanned surgery requiring more than one overnight stay in the hospital within the previous week
Recruitment (To minimize selection bias) RD's recruited the first two patients meeting inclusion criteria each day, up to six per week, with a goal of 5-10 patients.
Recruitment of RD's: Dietitians were recruited through multiple venues: Wisconsin Dietetic Assocaition practice survey, work site visits, and state district meetings and newsletters. 16 regional 1-hour training sessions were conducted, and 111 dietitians were registered and trained. 28 withdrew soon, 59 of the remaining 83 contributed data.
Design: Time Series
Blinding used (if applicable) not applicable
Intervention (if applicable):
RD's provided diabetes nutrition education / counseling according to their facility's policy. All subjects received face-to-face nutrition education/counseling at baseline; additional sessons were scheduled at the discretion of the subject and dietitian, but were not required.
Data was collected using an intervention record, a baseline report, and 3-month and 6-month follow-up reports, using original and previously utilized assessmsent tools. Subjective data were colleted in the face-to-face or telephone interviews. Objective data were obtained via chart review at each time point. Self-management behaviors were assessed through responses of subjects.
Intervention record included dates and lengths of sessions, session type, setting, charge, and frequency with which specific therapeutic lifestyle change topics were addressed.
A follow-up survey was sent to the 83 participating RDs 4 months after completion of data collection, regarding ease of participation, problems and rewards encountered, and interest in participation in future studies. 61 responded.
Statistical Analysis Repeated-measures analysis of variance, paired t-test, Wilcoxon signed rank test, sign test, Spearman correlation, and X2 analysis were conducted.
Timing of Measurements Baseline, 3-months, 6 months
- Glycemic control (HbA1c, fasting glucose)
- Coronary heart disease risk (calculated with formula from Framingham Heart Study Coronary Heart Disease Risk Prediction Chart)
- Self-management behaviors
- Quality of life
- Dietitians' perceptions of the study were also measured
- Nutrition intervention per facility protocol
Control Variables not specified
Initial N: 244 (119 were men)
Attrition (final N): 22 were lost to follow-up. Intervention records were completed for 221, complete or partial data was obtained on 205 at 3 months, and 208 at 6 months. Intervention records plus data from baseline, 3 months and 6 months were obtained for 184 subjects.
Age: not specified
Ethnicity: not specified
Other relevant demographics: not specified
- baseline 8.7 ± 2.0
- 0-3 month change: -1.4 ± 2.1
- 0-6 month change: -1.7 ± 2.0
- 3-6 month change: -0.4 ± 1.2
5 year Coronary Heart Disease Risk (%):
- baseline 11.5 ± 6.0
- 0-3 month change: -2.0 ± 3.0
- 0-6 month change: -3.5 ± 6.1
- 3-6 month change: -0.4 ± 3.8
Weight and glycemic control, coronary heart disease risk, and self-management behaviors improved significantly between baseline and 3 months, and between baseline and 6 months.
Weight, BMI, and HbA1c also improved significantly between 3 months and 6 months.
Increased time and/or number of sessions with the RD were associated with weight loss and reduced HbA1c, fasting plasma glucose, total cholesterol, and triglyceride levels. Self-perceived health status and missed work days were significantly improved at 6 months.
Obstacles for the RD's were: difficulty obtaining current lab values, lack of time, and inability to reach subjects for follow-up.
Clinical improvements were greatest between baseline and 3 months, with stabilization between 3 and 6 months, suggesting ongoing intervention is needed to support continued clinical progress.
- Positive health, behavior, and quality-of-life outcomes were demonstrated following nutrition counseling for type 2 diabetes.
- RD's in the study appreciated the ready-to-use forms, tools, and training that were provided.
- RD's in the study found satisfaction in being part of a larger research project.
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?||???|
|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?||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?||N/A|
|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.)||N/A|
|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?||???|
|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?||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?||???|
|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?||???|
|7.7.||Were the measurements conducted consistently across groups?||N/A|
|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|