EAL

H/A: Foodborne Illness (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

The purpose of this study was to provide food and medical nutrition therapy to a minimum of 50 clients with HIV/AIDS in Monroe County, NY, for a six-month period, and to offer training in a nine-county region to preparers and deliverers of home-delivered meals, home-health aides, allied health professionals and dietitians.

Inclusion Criteria:

HIV-positive or have the diagnosis of AIDS
Live in Monroe County
Have periods of frailty that prevented leaving the house or preparing nutritious meals easily.

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment

Patients were referred from the Visiting Nurse Service of Rochester and Monroe County, Inc., Meals on Wheels program.

Design

Before-and-after study.

Intervention

Upon recruitment and designation of eligibility in the study:

Subjects were provided daily meals (two meals per day, seven days per week) designed to provide more than 2,000kcal and 100g of protein (approximately 40% of energy from fat)
Subjects were provided weekly high-energy, high-protein, shelf-stable Snack Pack that provided a daily average of 200kcal and 6.5g protein
On the first visit, subjects were provided a Medical Nutritional Supplement Sampler Pack, which contained several flavors of ready-to-use, lactose-free oral nutritional supplements
Dietitian visits were scheduled. Visits included an assessment of the participant's nutritional risk factors, development of an individualized care plan, nutritional counseling and nutrition and food safety information. Within the first week of program enrollment, the dietitian scheduled a 75-minute visit with the client; if possible the community health nurse also attended. A one-hour nutrition counseling visit, which was scheduled four weeks to eight weeks later with the participant and a person of their choice, included counseling, care plan follow-up, problem observation and reinforcement of nutrition and food safety education with handout materials.
After each dietitian visit, each participant completed questionnaires about the Snack Pack and Supplement Sampler Pack. Dietitians completed questionnaires on individual client objectives and subjective responses to the program.
At six months, each of the four dietitians completed a final questionnaire assessing the overall program.

Statistical Analysis

Data were reported from the dietitians' questionnaires and objective client data. Percentages were reported.

Data Collection Summary:

Timing of Measurements

Measurements were taken at the initial dietitian visit and at the follow-up visit (four weeks to eight weeks after the initial visit).

Dependent Variables

Food consumption
Acceptance
Nutritional needs
Weight, based on self-report
Eating difficulties.

Independent Variables

Meals, Snack Pack and Supplement Sampler Pack
Medical nutrition therapy
Education.

Control Variables

None.

Description of Actual Data Sample:

Initial N

50 clients served during a six-month period.

Attrition (final N)

47 (33 male) initial visits were made. 35 participants received follow-up counseling.

Age

Mean age, 38 years (range 21 years to 63 years).

Ethnicity

Not stated.

Other relevant demographics

Not stated.

Other data

39 (93%) were taking at least one medication at the time of the first visit
Activity level was light or sedentary for 32 of 44 participants (73%)
Seventeen of 36 participants (47%) were taking vitamin/mineral supplementation.

Location

Monroe County, New York.

Summary of Results:

Other Findings

Meals

Dietitians thought the meals were meeting the nutrition needs of 27 of 39 participants (69%); this increased to 26 of 36 (72%) at the second visit. Acceptance of the meals was consistent: 36 of 43 participants (84%) at visit one and 31 of 36 (86%) at visit two described the meals as "good" or better.

Snack Pack

The Snack Pack was well-accepted: 48 of 52 participants (92%) ate most of it, which included 32 participants (62%) who ate all of the food in it. Dietitians reported that 16 of 17 (94%) and 29 of 30 (97%) participants after visit one and visit two, respectively, reported that the Snack Pack was especially useful on days when nausea or other disease- or medication-related symptoms made eating the daily meal difficult.

Supplement Sampler Pack

92% of participants said they enjoyed receiving the Supplement Sampler Pack and thought that they could now choose the supplement they preferred on the basis of the education provided by the dietitians and taste of the product. Dietitians stated that 32 of 36 (89%) and 27 of 33 (82%) participants at visit one and visit two, respectively, could benefit from regular use of medical nutritional supplements.

Weight

13 of 35 participants gained weight (mean gain, 6 pounds)
11 of 35 maintained their weight
11 of 35 lost weight (mean loss, 5 pounds).

There was a decrease in the number of participants who reported symptoms and eating difficulties at visit two [19 of 30 (63%) compared with visit one [36 of 47 (77%)].

Author Conclusion:

The HIV/Home Delivered Meals program met our program goals and seemed to be an effective way to work with other community agencies to reach people with HIV and AIDS in the community and improve their health and well-being. Because two thirds of the participants maintained or increased weight, this or a similar program could be valuable in other locations.

Funding Source:

Reviewer Comments:

Weight was based on self-report. Only 35 of 47 participants received a second visit.

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?	???
	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?		???
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	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.)	N/A
	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?	???
	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?	N/A
	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?		N/A
	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?	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?	Yes
	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?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	???
	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?	No
	7.7.	Were the measurements conducted consistently across groups?	N/A
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		No
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	No
	8.2.	Were correct statistical tests used and assumptions of test not violated?	No
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	No
	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)?	???
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	No
	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?		No
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	No
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?	???