EAL

H/A: Dietary Intake (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To examine, via secondary analysis of patients' nutrition diaries, the differences in nutritional intake and body mass index (BMI) in patients with HIV with chronic diarrhea
To evaluate the quality of diets against national dietary guidelines.

Inclusion Criteria:

Individuals at least 18 years of age and older
Diagnosed with HIV
Experienced a minimum of three episodes of loose, watery or liquid stools in a 24-hour period for at least three weeks or more.

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment

The Healthy Life Choices Project study was conducted from 1997 to 2001, and the study was conducted at a university medical center in New York City. Recruitment methods were not described.

Design

Cross-sectional analysis of a cohort study.

Blinding used

Not applicable.

Intervention

Not applicable.

Statistical Analysis

Means and standard deviations of nutrients were analyzed and compared against the National Cholesterol Education Program (NCEP) recommendations, the 2000 Dietary Guidelines for Americans and the Food Guide Pyramid.
One-way analysis of variance was used to evaluate the relationship between BMI and mean intake from fat, saturated fat, polyunsaturated fat, monounsaturated fat, cholesterol, fiber and sugar
Subjects who consumed whole milk, non-diet soft drinks and liquid supplements at least once daily and the number of subjects who ate fish during the seven-day food diary collection were compared against the subjects who did not consume these food items using the independent Student T test
Post hoc analysis was done using the Bonferroni correction.

Data Collection Summary:

Timing of Measurements

All subjects completed pre-study food diaries, and height and weight were measured.

Dependent Variables

Patients were categorized using baseline BMI as normal weight (BMI=18.5 to 24.9), overweight (BMI=25.0 to 29.9) and obese (BMI>30).

Independent Variables

Nutritional intake was estimated using seven-day nutritional diaries, in terms of dietary fats, cholesterol, macronutrients, fiber, and sugar and basic food group servings per day
Baseline food diaries were analyzed using Food Processor SQL software (ESHA Research).

Description of Actual Data Sample:

Initial N: 75 patients with HIV

Attrition (final N): 75 patients (53 males). 73 had BMI measurements. 72 had nutritional data.

Age: Mean age, 43.5±10.1 years

Ethnicity: 46% African American, 33% Hispanic, 19% white, 1% Asian, 1% other

Other relevant demographics: All participants were using highly active antiretroviral therapy medication regimens

Location: United States.

Summary of Results:

Key Findings

Mean BMI was 25.1±3.2 for men and 26.8±7.1 for women
39.7% and 13.3% of participants were overweight and obese, respectively
The mean intake of fat, saturated fat and cholesterol was more than recommended in the NCEP, whereas the mean intake of monounsaturated fat, polyunsaturated fat and fiber was less than the NCEP guidelines
Participants did not meet the minimum serving suggestions in the 2000 Dietary Guidelines for Americans and the Food Guide Pyramid for the intake of dairy products, fruits and vegetables
The consumption of fats, oils and sweets was very high for all groups
Mean consumption of meats and breads was within the recommended servings
Although the results were not statistically different among groups, grams of fiber intake were lowest for individuals with BMI>30.

Author Conclusion:

Early in the HIV epidemic, weight loss and wasting were indicative of advanced disease; the general public perceived that thin or underweight individuals were infected with HIV.

The increased consumption of liquid supplements among overweight and obese study participants pre-study may be related to the perception that increased body weight can prevent opportunistic infections and HIV wasting. It has also been suggested that people living with HIV may be more afraid of the health consequences of unintentional weight loss than the consequencesof obesity. Several studies have reported that overweight and obesity are prevalent among HIV patients and are under-recognized by clinicians.

Evidence has shown that increased body weight has been associated with a slower progression of HIV disease; the effects of unintentional weight loss on the course of HIV infection are only beginning to be explored. The impact of deliberate weight loss in HIV care is an important aspect to understand because following the NCEP diet can lead to weight reductions. With the advancement of HIV care, individuals are living longer, and the impact of excessive body weight remains to he understood.

Funding Source:

Government:

NIH/NINR, NIH/GCRC

Reviewer Comments:

Recruitment methods not described. Measurements not made in all subjects. Authors note the following limitations:

Nutritional intake for the overweight and obese categories may be underestimated, but other explanations cannot be excluded
The sample size may not have provided adequate power to detect all the differences among BMI categories.

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?	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?	???
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?	???
	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?		???
	7.1.	Were primary and secondary endpoints described and relevant to the question?	N/A
	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?	???
	7.7.	Were the measurements conducted consistently across groups?	???
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)?	???
	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