UWL: Association With Outcomes (2009)
Citation:
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
To identify the effect of recent widowhood on eating behavior, dietary intake, depression and cognitive and physical functioning by comparing widowed elders to age-, sex- and race-matched controls.
Inclusion Criteria:
- All Cardiovascular Health Study participants who became widowed while participating in the study and were widowed for at least six months at the time of their evaluation
- Participants were randomly matched for age, sex and race with randomly-selected married participants from the same study
- All participants attended the research clinic between September 1995 and June 1996
- All were ambulatory and able to come to the University of Pittsburgh clinic.
Exclusion Criteria:
None specifically mentioned.
Description of Study Protocol:
Recruitment
- Study was based on systematically collected data obtained from a large cohort study, the Cardiovascular Health Study
- 58 recently-widowed participants were recruited from the CHS cohort, Pittsburgh center
- Participants were randomly matched for age, sex and race with randomly-selected married participants from the same study
- All participants attended the research clinic between September 1995 and June 1996.
Design
Case-control analysis of retrospective cohort data.
Statistical Analysis
- Sample size calculations resulted in 52 participants needed for each group using 80% power and a significance level of 0.05
- Statistical analyses included ANCOVA and T-tests for continuous variables
- Contingency table analysis was performed using the chi-square test or Fisher's exact test as appropriate for comparison between widowed and married participants
- The Mann-Whitney nonparametric test was used to compare the number of participants in each weight pattern
- A logistic regression model was constructed to assess the association of the variables measured and weight-change pattern
- Variables that correlated to weight change (using Spearman's correlation coefficients) and that had a significance level of 0.1 were entered into the model.
Data Collection Summary:
Timing of Measurements
- Weight change from baseline (1989 to 1990) and following widowhood was measured at each annual visit
- Dietary intake was assessed once during the 1995 to 1996 visit
- Other variables were assessed during clinic interview on 1995 to 1996 visit.
Dependent Variables
- Weight was measured a with standardized balance beam scale
- Dietary intake was assessed using Willett's semi-quantitative Food Frequency Questionnaire, administered in an interview
- Eating behavior was assessed through an interview developed based on the synthesis and modification of three previously validated questionnaires: Questionnaires on eating behavior and on feelings related to eating and the Nutrition Risk Index
- Depression was measured with depression index score, evaluated using the Center for Epidemiological Studies Depression Scale (CESD)
- Cognitive functioning was assessed using 3MSE, a combination of methods including the Folstein mini-mental state examination and the digit-symbol substitution test
- Physical functioning was assessed using a modified version of the Health Interview Survey Supplement (HISS) on aging questionnaire, which assessed activities of daily living and instrumental activities of daily living
- Subjective health status was self-reported by participants.
Independent Variables
Widowed vs. married.
Description of Actual Data Sample:
- Initial N: 58 recently-widowed elderly subjects and 58 married subjects from Pittsburgh center (which, overall, includes 1,275 elderly people)
- Attrition (final N): As above; 10 men and 48 women in each group
- Age: Mean, 74 years at the beginning of the study. Mean age was 77.6 years in both groups
- Ethnicity: Not mentioned
- Other relevant demographics: Mean widowed years was 2.9±1.7 years
- Anthropometrics: Widowed and married subjects matched for age, sex and race. The number of health events, hospitalizations, alcohol and tobacco use and level of physical activity were similar in both groups.
- Location: Pittsburgh, Pennsylvania.
Summary of Results:
Comparison of Selected Dietary Intake, Eating Behavior and Non-Nutritional Variables Between Cases and Controls
Variables |
Widowed (N=58) | Married (N=58) | P-Value |
3MSE Score |
91.9±7.5
|
94.2±5.6
|
0.08
|
Depression Index Score |
5.98±4.4 |
6.87±7.2 |
0.76 |
Physical Functioning Score |
0.43±0.8
|
0.48±1.4
|
0.93
|
Subjective Health Status |
N/A
|
N/A
|
0.89
|
Meals Skipped per Week |
1.24±2.3
|
1.13±2.2
|
0.69
|
Frequency of Eating Alone per Week |
15.9±6.7
|
3.8±4.5
|
<0.001
|
Number of Snacks per Day |
1.31±1.36
|
2.44±1.12
|
<0.001
|
Commercial Meals per Week |
2±1
|
1±0.77
|
0.04
|
Number of Food Groups Eaten per Day |
3.79±0.52
|
3.84±0.37
|
0.13
|
Frequency of Eating Homemade Food per Week |
3.7±0.78
|
4.3±1.28
|
0.002
|
Enjoyment of Eating |
3.8±0.65
|
4.21±0.45
|
0.003
|
Frequency of Feeling No Wish to Eat |
1.79±1.18
|
1.46±0.92
|
0.07
|
Feeling Score |
2.55±0.75
|
2.7±0.53
|
0.09
|
Eating Behavior Score |
1.70±0.50
|
2.3±0.71
|
<0.001
|
Nutrition Risk Index Score (Percentage at Risk) |
14%
|
17%
|
0.61
|
Kcal |
2,018±572
|
2,018±616
|
0.48
|
Vitamin A (IU) |
3,625±5,757
|
5,404±5,757
|
0.04
|
Vitamin C (mg) |
317.1±321
|
327.1±236.5
|
0.56
|
Vitamin B-2 (mg) |
5.20±11.29
|
3.70±13.5
|
0.62
|
Niacin (mg) |
34.50±27
|
37.2±28.4
|
0.91
|
Vitamin E (IU) |
67.5±146.7
|
149.8±146.7
|
0.01
|
Other Findings
- Mean weight loss and the prevalence of weight loss were significantly higher among widowed participants
- Widowed participants lost 2.03±8.13 lbs, whereas controls gained 0.41±4 lbs (P=0.045) in the same year
- From baseline, widowed participants lost 1.40±4.38 lbs vs. a 2.40±0.8-lb gain among controls (P=0.02)
- Among the widowed group, 41% followed a pattern of weight loss, whereas only 26% of controls followed this pattern (P=0.035)
- The widowed group ate more meals alone (P<0.001), more commercial meals per week (P=0.034), and fewer snacks and homemade meals; they also enjoyed their eating less (P<0.001)
- None of the non-nutritional variables differed between the groups; these included depression score, cognitive functioning, subjective health status and physical functioning
- Higher cognitive functioning score, younger age and better appetite were protective against weight loss. Widowhood increased the risk for weight loss (odds ratio, 5.4; P=0.04), as did older age (odds ratio, 2.42; P=0.04), lower cognitive functioning (odds ratio, 0.33) and diminished appetite (odds ratio, 0.34).
- Higher physical functioning scores, associated with higher disability (odds ratio, 0.33; P=0.02), was protective against weight loss
- Higher education was associated with weight loss (odds ratio, 2.8; P=0.04).
Author Conclusion:
- The results of this study show clearly that the effect of widowhood on weight loss is real and may be potentially harmful
- Widowhood is associated with changes in eating habits and in enjoyment of eating, together with food-related activities, such as cooking and shopping
- Health services providers should be aware of the risks associated with widowhood and should invest greater effort in programs that seek to prevent nutritional deterioration
- Future research needs to identify key behaviors resulting in weight loss in both men and women, so that intervention can be directed at those target areas
- An ideal intervention program for widowed elderly people should be simple, flexible and inexpensive. Its delivery can then be modified to match the needs of various populations. The efficacy of such a program should be measured in fewer deaths, institutionalizations, and hospitalizations and in weight preservation among newly-widowed elderly.
Funding Source:
Other: | Not reported |
Reviewer Comments:
Authors note the following limitations:
- Retrospective design
- Potential for bias in the widowed group, because data were collected at least six months following the event of widowhood and only from participants who could attend the clinic visits: It is possible that widowed participants who were sicker, depressed, severely disabled or those dying within the half year were missed
- Under-representation of men precludes generalization to both sexes.
Quality Criteria Checklist: Primary Research
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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) | N/A | |
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) | N/A | |
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? | 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.) | 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? | 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? | Yes | |
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? | N/A | |
6.2. | In observational study, were interventions, study settings, and clinicians/provider described? | Yes | |
6.3. | Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? | N/A | |
6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | N/A | |
6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | N/A | |
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? | N/A | |
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? | 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? | No | |
10.2. | Was the study free from apparent conflict of interest? | Yes | |