EAL

UWL: Food, Appetite and Environment (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To examine the effects of a regular diet in the management of type 2 diabetes in a nursing home, by comparing the glycemic response of residents with type 2 diabetes living in a nursing home that were fed a regular diet and a no-concentrated sweets diet.

Inclusion Criteria:

Type 2 diabetes
Orally fed.

Exclusion Criteria:

Terminally ill residents
Residents with an active infection.

Description of Study Protocol:

Recruitment

All subjects at the 200-bed skilled nursing facility who had type 2 diabetes and who were orally fed were included.

Design

Non-randomized clinical trial. Patients were divided into two groups according to attending physician.

Intervention

Regular diet or no-concentrated-sweets diet.

Statistical Analysis

Standard descriptive statistics were used to characterize groups
Student's T-test for independent samples was used to compare group means
To compare categorical variables, chi-square for contingency tables was used
Student's paired T-test was also used.

Data Collection Summary:

Timing of Measurements

Baseline values were defined as the value one month prior to the diet change. Data collection done at baseline and three months after the diet change. Glycated hemoglobin measured again at six months.

Dependent Variables

Body weight measured in everyday clothes and shoes at the same time of day
Mean fasting blood glucose and mean blood glucose levels
Glycated hemoglobin
Serum albumin
Serum hemoglobin.

Independent Variables

Regular diet or no-concentrated-sweets diet

Control Variables

Age
Sex.

Description of Actual Data Sample:

Initial N: 28 subjects, nine men, 19 women, 14 in each group
Attrition (final N): 28
Age: Mean 82±7.5 years (range 59 to 93 years). 82.9±6.5 years in control group, 81.1±8.4 years in intervention group.
Ethnicity: 90% white
Anthropometrics: Groups were similar at baseline in all respects except that the control group had a lower mean fasting blood glucose concentration (P=0.04)
Location: St. Louis, Missouri.

Summary of Results:

Variables	Control Group (N=14)	Intervention Group (N=14)	P value
Baseline BMI (kg/m²)	26.8±5.4	28.5±7.8	0.50
Baseline glycated hemoglobin (%)	6.0±0.6	6.7±1.1	0.14
Baseline mean fasting blood glucose (mmol per L)	5.8±1.8	8.2±3.0	0.04
Baseline mean blood glucose (mmol per L)	7.8±1.9	9.8±2.6	0.10
Baseline albumin (g per L)	33.0±3.0	34.0±5.0	0.76
Baseline hemoglobin (g per L)	108.7±15.0	107.5±7.7	0.83
Three-month BMI (kg/m²)	28.0±6.7	29.3±7.9	0.64
Three-month glycated hemoglobin (%)	6.7±1.5	7.0±1.1	0.75
Three-month mean fasting blood glucose (mmol per L)	6.6±1.7	7.3±2.1	0.45
Three-month mean blood glucose (mmol per L)	7.8±1.9	8.1±2.3	0.76
Three-month albumin (g per L)	35.0±7.0	34.0±4.0	0.80
Three-month hemoglobin (g per L)	106.0±14.5	111.0±18.1	0.63
Six-month glycated hemoglobin (%)	6.4±1.5	6.7±0.9	0.57

Other Findings

At three months after the diet change, there was no difference between the groups in BMI, mean fasting blood glucose, mean blood glucose levels, serum albumin and serum hemoglobin.

The group mean for glycated hemoglobin was not different between the two groups at baseline, three months or six months.

Increase in diabetic medication was required in both groups.

Author Conclusion:

There is evidence that the residents with diabetes in long-term care facilities can be successfully managed with a regular diet without a limitation on concentrated sweets. We further recommend that glucose levels should be monitored and medication adjusted, rather than restricting the diet for these high-risk residents.

Funding Source:

Reviewer Comments:

Significant differences between groups at baseline. Small sample sizes, power analysis not completed. Authors note that they examined a small and predominantly white population and were unable to measure increased consumption of food by residents in this population.

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?	???
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?		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?	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?		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?		???
	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?	???
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	???
	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?		???
	7.1.	Were primary and secondary endpoints described and relevant to the question?	???
	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?		???
	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)?	???
	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