EAL

UWL: Medical Nutrition Therapy (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To characterize the nutritional and cognitive function in Group Living for Demented Elderly (GLD)
To examine the effects of oral supplementation on nutritional, cognitive and functional status in a six-month follow-up
To test whether nutritional supplements could affect the rate of decline in the cognitive function or in ADL activities.

Inclusion Criteria:

Living in one of two different units of group-living for demented elderly people (GLD) in two southern suburbs of Stockholm, Sweden
Diagnosed with dementia.

Exclusion Criteria:

Relatives expressed the wish that the member not participate in the study.

Description of Study Protocol:

Recruitment

All residents living in one of two GLD units in southern suburbs of Stockholm were invited to participate.

Design

Controlled non-randomized study.

Intervention

The participants in the interventional setting received two 200-ml oral liquid supplements daily during the five-month period of the intervention
A juicy supplement was given in between meals in the afternoon
A balanced supplement was given in the evening when the prescribed drugs were distributed
Personnel at the intervention site attended a 12-hour educational program about nutrition and diet for the elderly
Lectures were combined with practical exercises such as calculating BMI, making and testing nutritional drinks, thickening or enriching drinks of various types and trying foods with various consistencies.

Statistical Analysis

Student's T-test, the Mann-Whitney U-test and X² test were used in accordance with the distribution of variables
Possible changes at the follow-up were evaluated by the paired T-test or Wilcoxon's Sign Bank Test
For correlation analyses, Pearson's and Spearman's correlation coefficients were calculated depending on the distribution of the variables
Multiple regression analyses were performed in order to evaluate possible independent relationships between the variables
The Statistica program package (Statsoft, OK, United States) was used for the statistical calculations.

Data Collection Summary:

Timing of Measurements

Pre- and post-intervention.

Dependent Variables

Mini-mental State Examination
The following parameters collectively comprised the Nutritional Score Index, used in the study:
- BMI
- Triceps skinfold thickness
- Serum albumin
- Serum transferrin
- Serum B₁₂
- Serum hemoglobin
- Serum Insulin-like growth factor-one.

Independent Variables

The participants in the interventional setting received two 2000-ml oral liquid supplements daily during the five-month period of the intervention
A juice supplement was given between meals in the afternoon
A balanced supplement was given in the evening when the prescribed drugs were distributed
Personnel at the intervention site attended a 12-hour educational program about nutrition and diet for the elderly
Lectures were combined with practical exercises such as calculating BMI, making and testing nutritional drinks, thickening or enriching drinks of various types and trying foods with various consistencies.

Control Variables

Level of dementia
Co-morbidities.

Description of Actual Data Sample:

Initial N

22 out of 23 residents participated (84% females) served as the experimental group
14 out of 18 residents (93% female) at the second site participated as the control group.

Attrition (Final N)

21 subjects in the experimental group
12 subjects in the control group
Two residents passed away and one was hospitalized.

Age

Mean age, 84±4 years.

Other Relevant Demographics

Cardiac co-morbidity (nine subjects)
Neurologic/psychiatric co-morbidity (eight subjects)
Pulmonary co-morbidity (three subjects)
Five participants had more than one major disease
Other diagnoses (not specified) were found in five participants
Six subjects did not suffer from any chronic illness
Two residents had diabetes.

Anthropometrics

No significant changes were found between the groups.

Location

Two southern suburbs of Stockholm, Sweden.

Summary of Results:

	GLD-I Month Zero	GLD-I Month Six	GLD-C Month Zero	GLD-C Month Six
Weight, kg	55.4	58.8	62.2	61.9
BMI	22.2	23.5	24.6	24.5
Se- albumin, g per L	40.6	38.6	38.4	35.8
Se-transferrin, g per L	2.2	2.1	2.1	2.1
Se-Hgb g per L	133	132	128	124
Se-B₁₂pmol per L	542	579	332	332
Se-IGF-1, mcg per L	145	140	100	96
NuSc
Zero: Well nourished	8/38	8/38	2/18	2/19
One to two: at risk for PCM	11/52	8/38	7/64	6/54
> three (PEM)	2/10	5/24	2/18	3/27

Other Findings

BMI less than 20 was found in 19% of the participants and 44% had BMI less than 23
BMI correlated with MMSE (R=0.43, P<0.01)
The weight of the residents in the intervention group increased by 3.4±3kg (P=0.001) at follow-up, whereas the weight remained unchanged in the control group
The cognitive function was low at the start in both groups (MMSE at approximately nine) and no apparent positive effect of the nutritional intervention was seen
The ADL functions appeared to deteriorate in both groups
A significant increase in TSF was noted in the women in the interventional group
Serum hemoglobin decreased in the control group
Serum albumin decreased in both groups but remained in the normal range
Serum concentrations of transferrin, vitamin B₁₂ and IGF-1 were unchanged in both groups
There was a significant correlation between serum levels of albumin and MMSE
Serum levels of IFG-I and B₁₂ did not correlate with anthropometric, functional or cognitive variables in this group of residents.

Author Conclusion:

Being underweight was common among demented elderly in group living and was related to low cognitive capacity. Five months of oral supplementation, along with education of personnel, was followed by a weight gain.
In this study, the nutritional treatment did not affect the rate of decline in cognitive function or Katz's ADL index.

Funding Source:

Government:

Swedish National Board of Health and Social Welfare

Industry:

Reviewer Comments:

76% ingested the liquid supplement as ordered, the rest of the subjects consumed half
It is reasonable to believe that weight gain was a combined effect of the liquid supplementation and the education program
The non-randomized design of the study hampers the possibility to draw firm conclusions
One cannot conclude that nutritional therapy has no effect on cognitive performance
No relationship was seen in this small sample of subjects between weight gain and Katz's ADL index or cognitive function, but this issue needs to be addressed in future studies.

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?	???
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?	Yes
	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.)	Yes
	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?	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?	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?	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)?	Yes
	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