DM: Effectiveness of MNT Provided by RD/RDN (2015)
Citation:
Takahashi M, Araki A, Ito H. Development of a new method for simple dietary education in elderly patients with diabetes mellitus. Geriatrics and Gerontology International, 2004; 4: 111-119.
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
NEUTRAL:Research Purpose:
The objective of this study was to compare the effects of simple dietary education on food intake, nutritional components and glycemic control to those of conventional dietary education.
Inclusion Criteria:
- Age: At least 60 years
- HbA1c at least 7.0%
- Mini-mental state examination (MMSE) score at least 24.
Exclusion Criteria:
- Patients with low abilities to carry out activities of daily life (ADLs)
- Patients with cognitive impairment, dementia, aphasia, malignancy or acute illness.
Description of Study Protocol:
Recruitment
- Subjects recruited from diabetic outpatients
- 30 subjects were receiving their first visit at the clinic, and 38 patients had visited the clinic for at least two years.
Design
Randomized controlled trial.
Blinding Used
Implied with measurements.
Intervention
- Subjects were randomized to either the Simple Education Group or the Conventional Education Group
- For both education groups, dietitians conducted a detailed interview covering lifestyle and dietary habits and assessing cognition, family status and family support of the patients
- The frequency for both simple and convention dietary education consisted of a mean of three sessions of about 30 minutes each over a three-month period
- The same dietitian took charge of both types of dietary education
- Simple education
- Patients were instructed to have three meals a day and take well-balanced meals including carbohydrate-containing food (staple food), protein-containing food (main dish) and fiber-containing food (side dish)
- They were told to measure the quantity of staple food so that it could be identified as part of the total energy intake
- The dietitian told them to take one to 1.5 dishes of protein-containing foods at every meal and to take as much food containing fish and soybean as they could (rather than meats and eggs)
- They were asked to have two dishes of vegetables per meal and instructed that fat-containing foods should make up no more than two dishes at breakfast or lunch and that sweets should be taken at most once or twice a week
- They were taught the number and amount of fruits that one could eat per day, which was one unit and advised that no more than one glass of milk should be taken per day, that sugar-free or low-sugar yogurt should be chosen and less than two units of alcohol should be consumed per day
- Leaflets showing the amount of staple food, main dish and side dish were used and a sample menu was shown to them using a food model.
- Conventional education
- Conducted using food exchange lists, consisting of four groups of food
- Patients are taught to measure food, how to compose a dietary menu using the food exchange lists and to keep a dietary record
- Food exchange lists, food model and leaflets showing the amounts of staple food and a well-balanced diet containing staple food, main dish and side dish were used.
Statistical Analysis
- Differences between simple and conventional dietary education in the demographic characteristics are baseline were assessed using chi-square tests for discrete variables and two-sample T-tests for continuous variables
- To test group differences in food and nutritional intake, HbA1c, body weights, serum cholesterol, triglycerides and HDL-cholesterol, analysis of covariance was performed using the corresponding pretest factor score as covariate
- Paired T-tests were used within each group to test the change from pre-test to post-test and two-sample T-tests were used to compare groups post-tests
- Results were regarded as statistically significant if P<0.05.
Data Collection Summary:
Timing of Measurements
Measurements made at baseline and at three, six, nine and 12 months after education.
Dependent Variables
- HbA1c
- Body weight
- Serum levels of total cholesterol, triglycerides and HDL-cholesterol
- Food intake for a week assessed with Yoshimura's food frequency questionnaire.
Randomization to the Simple Education Group or the Conventional Education Group.
Description of Actual Data Sample:
Initial N
68 subjects, 28 men, 40 women
- 30 new elderly diabetic outpatients
- 38 outpatients who had been visiting clinic.
Attrition (Final N)
No attrition reported
- New patients in simple education (N=15): Seven men, eight women; mean age, 67.4±8.0 years
- New patients in conventional education (N=15): 10 men, five women; mean age, 67.1±8.0 years
- Long-term patients in simple education (N=19): Six men, 13 women; mean age, 74.4±6.0 years
- Long-term patients in conventional education (N=19): Five men, 14 women; mean age, 74.2±5.3 years.
Age
As above.
Ethnicity
Assumed to be Japanese.
Other Relevant Demographics
None specifically mentioned.
Anthropometrics
- Among new patients, both groups were similar with respect to age, gender ratio, BMI, duration of diabetes, diabetes treatment, HbA1c levels and prescribed total energy
- Among long-term patients, groups had similar ages, gender ratios, BMI, duration of diabetes, diabetes treatment and prescribed total energy, however the HbA1c level was significantly lower in the Conventional Dietary Education Group than in the Simple Dietary Education Group at baseline.
Location
Japan.
Summary of Results:
Key Findings
New Patients
| Metabolic Marker | Education | Baseline | 3 Months | 6 Months |
12 Months |
|
HbA1c (%)
|
Simple | 8.1±0.7 | 7.0±0.6, P<0.001 | 6.7±0.7, P<0.001 |
6.9±0.9, P<0.01 |
| Conventional |
8.3±1.1 |
7.1±1.0, P<0.01 |
6.6±0.8, P<0.001 |
7.3±1.2, P<0.01 |
|
|
Body weight (kg) |
Simple |
57.5±8.6 |
55.7±8.0, P<0.05 |
56.3±7.2 |
56.8±7.3 |
| Conventional | 63.0±9.3 | 61.8±10.3, P<0.05 | 61.8±10.8 | 63.7±10.3 | |
| Total cholesterol (mg/dL) | Simple | 203±30 | 196±22 | 193±23 | 199±22 |
| Conventional | 212±39 | 202±23 | 196±24, P<0.05 | 197±22 | |
| Triglycerides (mg/dL) | Simple | 142±53 | 121±56 | 121±45 | 119±52 |
| Conventional | 120±56 | 159±91 | 147±78 | 148±76 | |
| HDL-cholesterol (mg/dL) | Simple | 59±17 | 57±12 | 56±10 | 59±16 |
| Conventional | 53±15 | 51±14 | 51±16 | 53±15 |
Long-term patients
| Metabolic Marker | Education | Baseline | 3 Months | 6 Months |
12 Months |
|
HbA1c (%)
|
Simple | 8.3±0.9 | 8.2±1.2 | 7.8±1.3, P<0.05 |
7.9±1.3 |
| Conventional |
7.7±0.6 |
7.6±0.7 |
7.5±0.8 |
7.4±0.7, P<0.05 |
|
|
Body weight (kg) |
Simple |
51.8±12.0 |
51.6±12.1 |
51.8±11.5 |
51.6±11.7 |
| Conventional | 54.7±7.8 | 53.5±7.9 | 52.9±8.1 | 52.0±8.2 | |
| Total cholesterol (mg/dL) | Simple | 208±36 | 196±35, P<0.001 | 201±27 | 215±87 |
| Conventional | 208±34 | 207±41 | 202±34 | 215±43 | |
| Triglycerides (mg/dL) | Simple | 107±36 | 107±39 | 116±47 | 105±45 |
| Conventional | 123±68 | 141±80 | 143±91 | 132±68 | |
| HDL-cholesterol (mg/dL) | Simple | 58±14 | 55±12 | 55±11 | 56±16 |
| Conventional | 54±12 | 52±13 | 52±14 | 56±14 |
Other Findings
- At baseline and after three months, there was no statistical difference in total energy intake between the two groups
- In the Simple Dietary Education Group, the total energy intake was reduced from 1,607±204kcal per day to 1,376±251kcal per day and in the Conventional Dietary Education Group, it was reduced from 1,648±185kcal per day to 1,386±184kcal per day
- Simple dietary education reduced the intake of carbohydrate and fat, as well as the ratio of carbohydrate to total energy and increased the ratio of protein to total energy
- Simple dietary education was effective in reducing the intake of sweets, fruits and soft drinks
- Simple dietary education tended to decrease the intakes of cereals, milks and oils
- Conventional dietary education increased the intake of seaweed and green-yellow vegetables
- There were no statistical differences in the intakes of meat, fish, green-yellow vegetables and alcohol before and after the educational sessions
- Both types of education increased the intake of mushrooms
- In new diabetic patients, simple and conventional nutritional courses reduced HbA1c to similar levels at three, six and 12 months, as well as intake of total energy, sweets and fruits at three months after the education
- In new diabetic patients, both types of education similarly reduced body weight at three months and there were no significant differences in lipid levels between or within groups, except for the total cholesterol levels between baseline and six months in the Conventional Dietary Education Group
- Long-term patients had no significant differences in total energy intake and HbA1c levels at three months, but at six and 12 months small decreases in HbA1c levels were observed for both the simple and conventional dietary education courses
- In long-term patients, there were no significant differences in body weights and lipid levels between or within groups, except for total cholesterol levels between baseline and three months in the Conventional Dietary Education Group.
Author Conclusion:
- Our results suggest that simple dietary education is useful and effective for elderly diabetic patients on their first visit in a similar fashion to the conventional dietary education
- Because of the small effects of both types of education on glucose control in the long-term patients, more psychosocial support may be necessary
- In summary, simple dietary education was similarly effective in improving total energy intake and in glycemic control compared to conventional education in new patients, however in long-term patients, the effects on glucose control and food intake were small and slow. For long-term patients, it may be necessary to use more psycho-social interventions.
- Since we excluded patients with low abilities to carry out activities of daily life (ADLs) and cognitive impairment, it is also needed to see whether simple education is feasible and effective or not in those who have mild cognitive impairment.
Funding Source:
| Other: | Not described |
Reviewer Comments:
- No attrition reported, even after one year
- Small numbers of subjects in groups
- Among long-term patients, the HbA1c level was significantly lower in the Conventional Dietary Education Group than in the Simple Dietary Education Group at baseline.
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Quality Criteria Checklist: Primary Research
|
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| 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? | No | |
| 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? | No | |
| 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? | No | |
| 4.1. | Were follow-up methods described and the same for all groups? | No | |
| 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%.) | No | |
| 4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | ??? | |
| 4.4. | Were reasons for withdrawals similar across groups? | ??? | |
| 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? | N/A | |
| 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)? | 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? | 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? | No | |
| 10.2. | Was the study free from apparent conflict of interest? | Yes | |