EAL

UWL: Food, Appetite and Environment (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To determine whether serving a five-meal pattern versus a traditional three-meal pattern would improve energy intake among elderly, extended-care residents with dysphagia.

Inclusion Criteria:

Residents of an extended-care facility associated with an acute-care hospital
Aged older than 65 years
Previously evaluated for dysphagia based on bedside evaluation by an experienced swallowing team
Receiving a texture-modified diet.

Exclusion Criteria:

Tube-fed
Medically unstable
Received a diabetic diet and already receiving small, frequent meals.

Description of Study Protocol:

Recruitment

All elderly residents with dysphagia meeting inclusion and exclusion criteria in an extended care facility.

Design

Randomized crossover trial.

Intervention

Randomized to three or five meals during an initial four-day study period, followed by the opposite meal pattern in a second period.

Statistical Analysis

The three- and five-meal menus and all food and fluid consumed by participants were nutritionally analyzed
Total energy and fluid contents were compared using unpaired T-tests
Paired T-tests used to assess differences in individual energy and fluid intakes between study periods
Power analysis indicated that the final sample of 31 residents provided 80% power to detect a difference of 100kcal per day (7.5% change).

Data Collection Summary:

Timing of Measurements

Two four-day study periods, separated by a four-week washout period.

Dependent Variables

Food and fluid consumption during each study period were weighed before and after each meal
Nutritional status was determined using the Mini Nutritional Assessment.

Independent Variables

Randomized to three or five meals during an initial four-day study period, followed by the opposite meal pattern in a second period
Energy content was the same in both periods.

Description of Actual Data Sample:

Initial N: 66 met entry criteria and 37 residents agreed to participate
Attrition (final N): 37 (five men, 26 women) completed the study, but only 31 were analyzed because six subjects had deteriorating medical conditions before or during the study
Age: Mean age 85±6.4 years (range 71 to 96 years)
Other relevant demographics: Mean BMI 20.4±3.4 kg/m²
Anthropometrics: Crossover study. The only notable difference between participants and eligible non-participants was that fewer participants required more than 20 minutes to feed (35.5% vs. 60.6%, P<0.05).
Location: Canada.

Summary of Results:

Energy and Fluid Content of Menus and of Foods and Fluids Consumed by Elderly Individuals with Dysphagia (N=31)

Variables	Three Meals	Five Meals	P value
Energy: Menu content (kcal per day)	1,661±185	1,651±177	0.830
Energy: Consumed (kcal per day)	1,325±207	1,342±177	0.565
Fluid: Menu content (ml per day)	1,116±387	1,148±330	0.730
Fluid: Consumed (ml per day)	612±176	698±156	0.003

Other Findings

Average energy intakes were similar between the three- and five-meal patterns (1,325±207kcal per day vs. 1,342±177kcal per day, respectively; P=0.565).

Fluid intake was higher with five meals (698±156ml per day) vs. three meals (612±176ml per day; P=0.003).

Author Conclusion:

Although the five-meal pattern increased fluid intake of residents with dysphagia, energy intake was not improved. Implementation of a five-meal menu posed some challenges within the structured setting of a care facility. Dietitians might need to consider other intervention strategies for increasing energy intake among this vulnerable group.

Funding Source:

Reviewer Comments:

Only a four-day study period. Small number of residents from one facility. Authors note that implementation of the five-meal menu posed some challenges:

For participants dependent on staff for feeding, time constraints placed on staff for other duties made feeding additional meals difficult
Some nursing staff believed that there was insufficient time between meals for residents to be hungry before the next meal.

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?		Yes
	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?	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?		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?	???
	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?	???
	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?	???
	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?	Yes
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