FNCE 2023
Session 357. Providing MNT for the Pediatric Type 1 Diabetes Population: What Does the Evidence Show?
Monday, October 9, 8:30 AM - 9:30 AM

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UWL: Association With Outcomes (2009)

Study Design:
- 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:


  • 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.


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


Widowed (N=58) Married (N=58) P-Value

3MSE Score


Depression Index Score




Physical Functioning Score
Subjective Health Status
Meals Skipped per Week
Frequency of Eating Alone per Week
Number of Snacks per Day
Commercial Meals per Week
Number of Food Groups Eaten per Day
Frequency of Eating Homemade Food per Week
Enjoyment of Eating
Frequency of Feeling No Wish to Eat
Feeling Score
Eating Behavior Score
Nutrition Risk Index Score (Percentage at Risk)
Vitamin A (IU)
Vitamin C (mg)
Vitamin B-2 (mg)
Niacin (mg)
Vitamin E (IU)

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
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