EAL

H/A: Monitoring of Food Intake (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To evaluate the nutritional, clinical and immunologic factors associated with human immunodeficiency virus (HIV) infection in inner-city patients with multiple risk factors.

Inclusion Criteria:

Men and women
Older than 18 years of age
All stages of HIV infection.

Exclusion Criteria:

Subjects who were alcoholics were excluded because of the confounding effect of alcohol on nutritional status.

Description of Study Protocol:

Recruitment

Cross-sectional nutrition evaluation done between January 1991 and January 1993. Subjects were prospectively recruited from the AIDS Center and the Neuro-AIDS Research Center at Mt. Sinai Medical Center.

Design

Cross-sectional nutrition evaluation.

Statistical Analysis

T-tests were used to compare patients who were at a stable weight with patients who had lost weight with regard to anthropometric, dietary and clinical variables
Spearman's rank correlation coefficient was used to examine the correlation between pairs of continuous variates
Chi-squared tests were used to test for differences in proportions.

Data Collection Summary:

Timing of Measurements

Patients were interviewed at the outpatient clinic at Mt. Sinai Medical Center, New York, NY.

Dependent Variables

Anthropometric measurements: Height, weight, body mass index (BMI), mid-arm circumference, triceps skinfold and mid-arm muscle circumference
History of weight changes (maintenance of pre-illness body weight or decrease from pre-illness weight status)
Dietary intake measured with three-day food records
Clinical laboratory tests: serum HIV antibody testing by ELISA, complete blood counts, studies of lymphocyte subgroups and tumor necrosis factor alpha.

Independent Variable

HIV infection.

Description of Actual Data Sample:

Initial N: 56 subjects (47 men, nine women)
Attrition (final N): 56
Age: 40±8 years for those with stable weight, 42±10 years for those who had lost weight
Ethnicity: 15 black, 23 Hispanic, 16 white, two unknown
Other relevant data: CD4 cells, 250x10⁶/L±264x10⁶/L for those with stable weight and 150x10⁶/L±181x10⁶/L for those who had lost weight
Location: New York, NY.

Summary of Results:

Variables	Patients with Stable Weight (N=25)	Patients Who had Lost Weight (N=31)	Statistical Significance of Group Difference
Weight Loss (kg)	---	9.2±6.2	---
BMI	25.5±5.2	21.2±2.4	0.0001
Triceps Skinfold (mm)	18.3±10.5	10.5±3.4	0.0001
Mid-Arm Circumference (cm)	31.6±4.4	27.1±2.9	0.0001
Mid-Arm Muscle Circumference (cm)	26.0±2.6	23.7±2.7	0.005
CD4 Cells x10⁶/L	250±264	150±181	0.05
CD8 Cells x10⁶/L	897±500	756±695	0.02
Absolute Lymphocyte Count (Cells x10⁶/L)	1,426±708	1,237±1,028	Not significant (NS)
Transferrin (g/L)	1.68±0.41	1.60 ± 0.46	NS
Albumin (g/L)	42±4	40±5	NS
Hemoglobin (g/L)	127±19	125±18	NS
Energy (kcal)	1,933±587	2,041±574	NS
Energy (kcal/kg)	26±8	32±10	0.02
Protein (g)	80±32	83±29	NS
Protein (g/kg)	1.1±0.4	1.3±0.5	0.02
Carbohydrate (g)	236±71	257±81	NS
Fat (g)	73±32	77±25	NS
Zidovudine (mg) Cumulative Exposure	282,882±193,148	320,250±223,681	NS

Other Findings

Patients were classified into groups according to whether they were at a stable weight (N=25) or had lost weight (N=31)
All anthropometric measurements, CD4 lymphocytes and CD8 lymphocytes were significantly lower in the patients who had lost weight
No differences were observed between the groups for absolute lymphocyte count or transferrin, hemoglobin and albumin levels
The mean energy intake of the 56 patients was 74% of the Recommended Dietary Allowance (RDA)
47 patients (84%) took vitamin or mineral supplements within a range of 2% to 50,000% of the RDA
No significant positive correlations were observed between nutrient intake, CD4 cells and absolute lymphocyte count.

Author Conclusion:

All anthropometric measurements, CD4 lymphocytes and CD8 lymphocytes were notably lower in patients with weight loss
The mean energy intake of the subjects was only 74% of the RDA
Megadoses of vitamin supplements were taken by a large number of patients, but no significant positive effects were observed for absolute lymphocyte count and CD4 cells
Although supplementation of micronutrients may influence the progression of HIV infection, a balanced nutritious diet may be more beneficial in maintaining or improving the physiologic status of the patients, however members of a high-risk population may benefit less from HIV-related social services and food or nutrition resources
With the growing number of injection-drug users in the acquired immunodeficiency syndrome population, it will be essential to develop comprehensive strategies to address the interconnected needs for medical and nutrition care
Ensuring that patients have adequate meals during an extended course of treatment in the outpatient clinic or that dietitians have meals available in group settings or through home delivery service may be the most appropriate nutrition intervention in these high-risk patients.

Funding Source:

Government:

National Institute of Neurological Disorders and Stroke (R01-NS28630), National Institute of Allergy and Infectious Diseases (U01-A1-72667) and the National Center for Research Resources (5M01 RR00071).

Reviewer Comments:

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?		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?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
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?	Yes
	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?	Yes
	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?	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?	N/A
	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)?	N/A
	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?	???
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