Unintended Weight Loss in Older Adults

UWL: Medical Nutrition Therapy (2007)

Citation:

Keller HH, Gibbs AJ, Boudreau LD, Goy RE, Pattillo MS, Brown HM. Prevention of weight loss in dementia with comprehensive nutritional treatment. J Am Geriatr Soc. 2003; 51(7): 945-952.

PubMed ID: 12834514
 
Study Design:
Non-Randomized Controlled Trial
Class:
C - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:

To determine whether body weight can be maintained or improved in dementia residents of special care units (SCUs) using a comprehensive intervention strategy, as influenced by standard nutritional care, enhanced dietitian time and menu and enhanced menu only.

Inclusion Criteria:
  • All current and new residents to the special care unit who were on the unit at least three months before completion of intervention period
  • All participants were being fed orally.
Exclusion Criteria:
  • Those with active cancer
  • Those requiring tube feeding, because those patients are transferred off the special care unit.
Description of Study Protocol:

Recruitment

All current and new residents on the special care unit who were on the unit at least three months before completion of intervention period. Recruitment of residents involved letters of information being sent to all family guardians of residents of the special care unit. Recruitment of facilities was not discussed.

Design

Non-randomized clinical trial.

Intervention (if applicable)

  • Intervention site vs. comparison site. Intervention included enhanced dietitian time (providing as-needed care on an individualized basis) and enhanced high-protein, high-energy diet.
  • Three time periods were compared: Nine-month baseline period, nine-month intervention period (enhanced dietitian monitoring and menu changes at intervention site) and 12-month post-intervention period (only menu changes at intervention site).

Statistical Analysis

  • Comparisons made within and between sites
  • Weight change over time was analyzed with a repeated measures analysis, controlling for various covariates such as pacing, type of dementia, sex, age, number of co-morbid conditions and medications
  • Bivariate analyses were completed for other outcomes of death, number of infections, falls and hospital days.
Data Collection Summary:

Timing of Measurements

Three time periods were compared: Nine-month baseline period during which both facilities received standard care, nine-month intervention period (enhanced dietitian monitoring and menu changes at intervention site) and 12-month post-intervention period (only menu changes at intervention site).

Dependent Variables

  • Primary outcomes of weight change over time, with full nutritional assessments completed at intervention site
  • Secondary outcomes of death, transfer off unit, infections and falls; data were collected and analyzed during the intervention period.

Independent Variables

  • Intervention site vs. comparison site
  • Intervention: Enhanced dietitian time (providing as-needed care on an individualized basis) and enhanced high-protein, high-energy diet.

Control Variables

Medical charts and basic anthropometric, behavioral and cognitive measures were completed for variables such as pacing, type of dementia, sex, age, number of co-morbid conditions and medications.

Description of Actual Data Sample:
  • Initial N: Four special care units (SCUs) in two long-term care facilities, 33 residents at the intervention site (39.4% male, 60.6% female), 49 residents at the comparison site (36.7% male, 63.3% female)
  • Attrition (final N): Assumed as above
  • Age: Mean age 79.7±7.2 years in Intervention group, 79.8±7.4 years in comparison group
  • Anthropometrics: Both facilities were municipally funded and of a similar size (approximately 300 beds) although the intervention facility was newer. Significant differences at baseline between residents of both facilities in terms of number of co-morbidities, number of infections, number of medications and gender as related to Barthel Index and BARS Score.
  • Location: Ontario, Canada.
Summary of Results:

Outcomes Compared by Site and by Weight Change Pattern (During Nine-month Intervention Period)

  Intervention Comparison

Weight Gain / Maintenance

Weight Loss

Dietitian time, minutes, mean ±SD 533.3±94.5, P<0.001 17.6±21.6 290.2±267.2, P<0.001

58.2±153.9

Deceased, % 6.1 16.3 6.8, P<0.05 29.6
Falls, mean ±SD 2.6±2.7 3.1±3.2 2.9±3.1 2.9±3.0
Infections, mean ±SD 2.3±1.6 2.6±1.7 2.4±1.6 2.8±1.9
Hospital days, mean ±SD 0.85±2.9 0.4±1.3 0.53±2.1 0.76±2.0
Left unit, (transferred / died / hospitalized), % 15.2 32.7 15.3, P<0.001 55.6
Months in study during nine-month intervention, mean ±SD 8.4±1.3, P<0.01 7.4±2.6 8.4±1.3, P<0.001 5.8±3.3

Other Findings

  • The intervention period that included the dietitian time and menu changes significantly promoted weight gain, compared with the standard treatment at the comparison facility (P<0.001)
  • Other covariates of pacing, type of dementia, sex, age, number of comorbid conditions and medications were also significant predictors of weight change
  • Weight gain or maintenance regardless of site was associated with survival.
Author Conclusion:

Body weight can be maintained in residents of special care units regardless of pacing and other clinical characteristics. The comprehensive intervention of clinical dietitian time and an enhanced menu designed to be individualized for ambulatory people with dementia promoted significant gains in body weight. A minimum 5% weight gain is associated with survival in these residents of special care units.

Funding Source:
Reviewer Comments:

Significant differences between resident groups at baseline, but some of these were controlled for in the statistical analysis. Intervention was not well described. Recruitment of facilities was not discussed. Original number of residents in the study is unclear, given the 30-month study timeline. Authors note the following limitations: Small sample size, lack of information on the socioeconomic condition of the residents, lack of control over calibration of scales, a crude measure of pacing status and lack of clarity on whether dementing diagnoses met standard criteria. Generalization of the study results should be cautioned.

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? ???
  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? ???
  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? ???
  4.4. Were reasons for withdrawals similar across groups? ???
  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? ???
  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? ???
  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)? 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? 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