Unintended Weight Loss in Older Adults

UWL: Food, Appetite and Environment (2009)

Citation:

Mathey MF, Vanneste VG, de Graaf C, de Groot LC, van Staveren WA. Health effect of improved meal ambience in a Dutch nursing home: A one-year intervention study. Prev Med. 2001; 32(5): 416-423.

PubMed ID: 11330991
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:

To investigate the influence of a one-year intervention combining selected social and environmental manipulations of food consumption on the nutrition and health status of nursing home residents.

Inclusion Criteria:
  • Older than 65 years of age
  • Resident in the home for more than three months at the start of the study.
Exclusion Criteria:
  • Parenteral nutrition
  • Terminal phase of a disease
  • Specific exclusion criteria for the analyses of biochemical indicators of health was applied for the patients with severe anemia.
Description of Study Protocol:

Recruitment

Four wards, each with 15 residents and comparable for diseases and treatment, were randomly assigned to be in either the control (two wards) or the experimental group (two wards). 60 residents were invited to join the study.

Design

Randomized parallel controlled trial. 

Intervention

Improvement of ambience focused on three points:

  • Physical environment and atmosphere of the dining room
  • Food service and meal situation
  • Organization of the nursing staff assistance, 

During the intervention, the same meals were served in both groups and the usual meal pattern was maintained: Breakfast and supper were bread-based meals and at noon a cooked meal was served.

Statistical Analysis

For the residents who completed the trial, means and standard deviations of baseline and absolute changes values were calculated per group for outcome variables. For the dropout group, only baseline characteristics and body weight data were analyzed. Changes were compared using an unpaired T-test for differences between groups and by using a paired T-test for differences between baseline and follow-up within groups.

Data Collection Summary:

Timing of Measurements

Dietary intake, biochemical indicators of nutritional and health status, and quality of life were assessed at baseline and after one year of intervention. Body weight assessed every four months.

Dependent Variables

  • Dietary intake data collected by project dietitians using both observation and weighing-back methods for three consecutive days
  • Biochemical indicators of nutritional and health status: Fasting blood samples
  • Quality of life assessed using Sickness Impact Profile and Philadelphia Geriatric Center Moral Scale
  • Body weight measured before breakfast using seated scale.

Independent Variables

Improvement of ambience through focus on physical environment and atmosphere of the dining room, food service and organization of the staff assistance.

 

 

Description of Actual Data Sample:
  • Initial N: 60 residents originally were invited to participate. 38 nursing home residents were enrolled.
  • Attrition (final N): 22 completed the one-year trial. Dropout cases were patients who failed to complete the study due to death (75%), move (12.5%) or personal reasons (12.5%).
  • Age: Mean age experimental group, 82.6±7.5 years; control group, 78.2 ± 7 years
  • Anthropometrics: Gender distribution, age and mean body weight were similar for control, experimental and dropout groups. Patients were comparable with respect to quality of life, diseases and treatments.
  • Location: The Netherlands.
Summary of Results:

 

Variable

Control Group, Baseline (N=10) Control Group, Absolute Changes (N=10)

Experimental Group, Baseline (N=12)

Experimental Group,  Absolute Changes (N=12)

Energy (kJ)

5,431±1,540 767±1,040 6,055±1,360

819±1,699

Energy (kcal) 1,292±368 185±247 1,440±324 199±406
Carbohydrate (g) 167±44 7±40 189±46 -4±48
Fat (g) 48±20 14±12 52±15 21±21

Protein (g)

47±16

7±11

52±15

8±16

Other Findings

Mean body weight significantly increased (+3.3kg, P<0.05) in the experimental group (N=12), but not in the control group (-0.4kg, P=0.78, N=10) and these changes differed significantly between groups (P<0.05).

Health status biochemical indicators and the SIP score remained stable in the experimental group, indicating relatively stable health conditions.

On the contrary, negative changes in the control group suggested a decline in health status.

Significant differences between groups were observed for hemoglobin, mean corpuscular hemoglobin and mean corpuscular hemoglobin concentration.

Dietary intake, which was insufficient at baseline (5.4±1.5 MJ for the control group and 6.1±1.4 MJ for the experimental group), increased in both groups. No differences in energy and macronutrient intake were observed between groups.   

Quality of life only measured for eight subjects in each group.

Author Conclusion:

In conclusion, improvement of the social ambiance of food consumption in this nursing home was a non-negligible way to stabilize health and nutritional status of nursing home elderly residents.

Funding Source:
Reviewer Comments:

High dropout rate due to death during the course of one year. Only residents from one nursing home participated. No explanation of the change in weight despite no difference in food intake between groups.

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? ???
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) ???
  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? ???
  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%.) ???
  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? 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? 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? Yes
  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? N/A
  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? 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