EAL

FNOA: Aging Programs (2012)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To examine the influence of the Elderly Nutrition Program (ENP) on nutritional health among ENP participants including targeting, delivery and costs of services. Additionally, ENP participants' nutrient intake and socialization patterns were compared to non-participants. This research supports a Congress mandated national evaluation of the ENP in order to support health policy development.

Inclusion Criteria:

ENP group:
- ENP participant
- Receives either congregate or home-delivered meals
Non-ENP group:
- Non-ENP participant
- Medicare beneficiary
- 60 years or older.

Exclusion Criteria:

Less than 60 years of age
Not participating in either ENP or Medicare.

Description of Study Protocol:

Recruitment

ENP group:
- Nationally representative ENP participants
- Methodology previously described
Non-ENP group:
- Matched sample identified by local ENPs
  - Same zip codes
  - Matched on key variables
- Used US Health Care Financing Administration Medicare beneficiary listings
- Randomized within zip codes and randomly sorted lists
- Screened and stratified by income and disability with random sampling
Interviews and data collection by trained staff.

Design

Case-control study:

Trained field staff conducted in-person interviews of ENP and matched non-ENP participants
Samples randomized to ensure that participant and non-participant samples would have approximately the same distribution of income and disability status
Detailed descriptive demographic and health information provided on ENP participants (ambulatory and home bound), which was compared to US elderly in general (based on US Census and Economic data) to demonstrate overall participation in ENP program.

Intervention

Participation vs. non-participation in Elderly Nutrition Program (ENP).

Statistical Analysis

Descriptive tabulations of ENP participants and general population of elderly
Difference of means and difference of proportions test to test statistical significance of group differences
Linear regression on the combined, unweighted sample of congregate participants, home-delivered participants and non-participants.

Data Collection Summary:

Timing of Measurements

One in-person interview.

Dependent Variables

Variable	Measurement
Demographics	Self-reported
Health status	Self-reported
Hospital and nursing home admissions	Self-reported
Physical functioning	Katz's standardized Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (I-ADL) inventories
Nutrient intake	24-hour dietary recall with validated instruments; Nutrient Data Systems nutrient database; Dietary Reference Intakes, Adequate Intake levels; Recommended Daily Allowances; standardized height and weights for Body Mass Index
Socialization patterns	Self-reported
Use of ENP services	Self reported; ENP program management reported administrative and meal cost data

Independent Variables

ENP participation vs. non-participation.

Description of Actual Data Sample:

Initial N

		Initial/final N	Response Rates
ENP	Ambulatory (congregate meals)	1,040	61%
ENP	Homebound (home delivered meals)	818	76%
Non-ENP		841	*Not reported

Attrition (Final N)

No attrition; single data collection point.

Age

All participants 60+
Average age:
- ENP ambulatory: 76 years
- ENP homebound: 78 years
- Non-ENP age not reported, but "matched for age" described as part of methodology
- All US population persons aged 60+: 72 years.

Ethnicity

		Black	Hispanic	Native American	Asian/Pacific Islander	All racial and ethnic minorities
ENP	Ambulatory	11%	7%	1.2%	1%	20%
ENP	Home bound	19%	5%	1.2%	0.01%	25%
Non-ENP		* Not reported
US elderly aged 60+		8%	4%	0.4%	1.6%	14%

Other Relevant Demographics

		Education			Marital Status				Poverty Status		Low-income Minority
		Began High School	Less than High School	High School /GED	Married	Widowed	Divorced/separated	Never Married
ENP	Ambulatory	19%	51%	28%	30%	53%	7%	7%	34%	79%	15%
ENP	Homebound	18%	57%	22%	26%	56%	12%	5%	48%	90%	16%
Non-ENP		* Not reported
US elderly aged 60+		4%	15%	66%	55%	33%	6%	4%	15%	38%	4%

Anthropometrics

Health-related and functional characteristics of ENP participants:

Characteristic		ENP		Non-ENP
		Ambulatory	Homebound
*Mean*				*Not reported
Number of diagnosed chronic health conditions		2.4	3.0
Number of ADL impairments		0.2	1.7
Number of I-ADL impairments		0.4	2.1
*Percentage*
Fair or poor current perceived health		33	63
Needs assistance with or has much difficulty with one or more ADL or I-ADL		23	77
Leaves home less than once per week		9	54
Weight outside healthy weight range		61	64
Underweight (BMI less than 22)		19	32
Overweight (BMI more than 27)		42	32
Hospital/nursing home stay during previous year		26	43
Long-term care services	Personal care services	6
	Homemaker services	23	66
	Home health aide services	2	16
	Adult daycare services	2	2

Location

Nationally representative samples based on ENP participation.

Summary of Results:

Key Findings

When comparing the demographics of ENP participants to older Americans in general, ENP participants:
- Are four to six years older than US elders
- Are more female (69% to 70% vs. 58%)
- Are twice as likely to live alone (57% to 60% vs. 25%)
- Have a higher proportion of minority participants (20% to 25% vs. 14%)
- Are likely to have achieved lower levels of education
- Are more likely to be widowed, divorced, separated or never married
- Have two to three times the proportion of impoverished elderly persons
- Have incomes below 200% of the US Department of Health and Human Services poverty level (79% to 90%)
- Have four times greater a proportion of low income elderly (15% to 16% vs. 4%)
When examining health characteristics, ENP participants:
- Have two to three chronic health problems
- 33% (ambulatory) to 63% (homebound) consider themselves in fair to poor health
- About 25% (ambulatory) to 77% (homebound) need assistance with or have considerable difficulty performing one or more ADL, including shopping for food or preparing meals
- 9% (ambulatory) to 54% (homebound) report leaving their home less than once a week
- By about two-thirds have a BMI outside the healthy range:
  - Ambulatory are more likely to be overweight
  - Homebound are more likely to be underweight
- About 25% (ambulatory) to 43% (homebound) have been hospitalized or stayed in a long-term care facility during the past year
- That receive congregate services are much less likely to have long-term care services than those who are homebound, except adult daycare services
- Ambulatory participants are more less likely than homebound to need long-term care services from all providers.

d	d	ENP Group Percentage	Non-ENP Group Percentage	Statistical Significance of P<0.001
Nutrient intake	Total energy	75.2	69.3	8.5
	Protein	117.8	108.8	8.3
	Vitamin A	166.9	133.9	24.6
	Vitamin C	119.5	105.1	13.6
	Vitamin D	40.2	30.7	30.6
	Vitamin E	47.8	41.9	14.1
	Thiamin	127.3	120.1	5.9
	Riboflavin	151.7	131.3	15.6
	Niacin	123.9	116.8	6.1
	Vitamin B₆	103.2	94.7	8.9
	Folate	63.5	58.5	8.3
	Calcium	61.2	49.3	24.2
	Magnesium	72.2	63.2	14.3
	Zinc	104.9	93.6	12.0
	Phosphorus	150.1	131.1	14.5
Monthly social contacts		97.2	83.0	17.1

* Only vitamin B₁₂ and iron were not significant.

Other Findings

The ENP program currently provides congregate and home-delivered meals to about 7% of the older population overall, including an estimated 20% of the nation's poor elders
Compared with non-participants, ambulatory and homebound ENP participants are better nourished (4% to 31% higher mean daily nutrient intakes, P<0.001) and achieve higher levels of socialization (17% higher average monthly contacts, P<0.001).

Author Conclusion:

The Elderly Nutrition Program is an efficient and effective program that accomplishes its objectives by providing community and home-based nutrition and health related services to older persons, including a high percentage of the poor and frail elderly.
ENP participants were better nourished and less socially isolated than matched non-participants.

Funding Source:

Government:

Grant from U.S. Department of Health and Human Services, Assistant Secretary for Aging, and the Office of the Assistant Secretary for Planning and Evaluation

Reviewer Comments:

Study is mostly descriptive on the ENP program including participants (ambulatory and homebound) compared to elderly US population demographics. Only dietary intake and social contact compared to the matched non-ENP group.
Subjects, 60+ years in age, self-reported data on health status, hospital and nursing home admissions, physical functioning, nutrient intake, socialization. Question the reliability of self-reported data.
Groups for ENP participants (N=1,850) and matched non-participants (N=841), although both large in size, vary significantly from each other in number
Unclear if only one 24-hour dietary recall was used per participant interview. To assess long-term nutrition status, more comprehensive inventory may have been appropriate. However, reviewer does note the large number of individual interviews conducted per group.
Demographic data for the non-ENP matched group was not noted. Demographic table included only comparative figures for "all persons aged 60 years and older in the US" obtained from 1990 census and housing data from US Census Bureau and US Department of Commerce. Would have liked to see demographic data for non-ENP matched group, even though the data analysis used multivariate regression to control for characteristics related to program participation and outcomes studied when analyzing dietary intakes and social contacts.

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?		Yes
	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?	Yes
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)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	???
	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.)	???
	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?	No
	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?	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.)	N/A
	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?		???
	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?	No
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	N/A
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	???
	7.5.	Was the measurement of effect at an appropriate level of precision?	???
	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