EAL

UWL: Food, Appetite and Environment (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To determine the feasibility of implementing a comprehensive buffet-style dining program and to determine the impact of the program on weight and biochemical indicators of nutritional status among nursing home residents.

Inclusion Criteria:

Older than 65 years
Have a mechanical soft or regular food consistency diet order.

Exclusion Criteria:

Medically unstable
Active malignancy or human immunodeficiency virus
Creatinine more than 260µmol per L
Complex dietary needs such as a gluten-free diet.

Description of Study Protocol:

Recruitment

Residents were recruited from three long-term care units. Methods were not described.

Design

Randomized clinical trial.

Intervention

Subjects were randomized to participate in the buffet-style dining program for supper only or to continue to receive the conventional tray-style meal served by the nursing home staff for a period of three months
Facets of the program included: Supervision of dining procedures by nursing staff, assistance by certified nursing assistants devoted to mealtime assistance and specially trained to provide the appropriate type and amount of assistance, food served on a steam table, allowing for a selection of a variety of foods, food choice by residents, second helpings of favorite foods, maintenance of ideal food temperatures and enhanced dining room environment.

Statistical Analysis

Sample size selected permitted 80% power. Means and standard deviations calculated for continuous variables and frequencies were determined for non-continuous variables. Group characteristics were compared using chi-square analyses for noncontinuous variables and for variables not normally distributed, and T-tests for continuous variables.

Data Collection Summary:

Timing of Measurements

Measurements made at baseline and at three months.

Dependent Variables

Height and weight obtained by research staff
Fasting blood specimens analyzed by contract laboratory.

Independent Variables

Buffet-style dining program for supper only or conventional tray-style meal served by nursing home staff.

Control Variables

Demographic characteristics obtained from medical records.

Description of Actual Data Sample:

Initial N: 40 residents recruited, 20 in the intervention group (19 female, one male) and 20 in the control group (13 female, seven males)
Attrition (final N): 40 residents
Age: Mean 80±6 years in intervention group, 80±8 years in control group
Ethnicity: 85% white, 15% nonwhite in intervention group, 75% white, 25% nonwhite in control group
Anthropometrics: Demographic characteristics were similar in both groups, except the control group had significantly more men than the intervention group
Location: Baltimore, Maryland.

Summary of Results:

Other Findings

Weight change from baseline in the intervention group ranged from 3.6kg gain to 9.8kg loss, with a mean change of -0.11±0.7kg
Weight change in the control group ranged from 4.5kg gain to 4.5kg loss, with a mean of 0.32±0.5kg
Group differences in weight, hemoglobin, hematocrit, total cholesterol, pre-albumin and total lymphocyte count were not significant.

Author Conclusion:

The results of the pilot study indicate that it is feasible to implement a buffet-style dining program in a long-term care setting. The buffet-style dining program did not result in suboptimal intake or adversely affect nutritional status. Although not assessed in the study, the subjects' quality of life seemed to be enhanced and overall resident satisfaction ratings with food and dining services increased 25% on the long-term care units and 52% on the rehabilitation unit. The facility's change to a buffet-style meal service did result in new costs.

Funding Source:

Reviewer Comments:

Recruitment methods were not described. Statistically significant differences between groups at baseline. Buffet-style meal for supper only; it might have had more impact if lunch was also buffet style.

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?	???
	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)	No
	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?	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.)	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?	N/A
	6.6.	Were extra or unplanned treatments described?	Yes
	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?	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?		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)?	N/A
	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