EAL

H/A: Dietary Intake (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To analyze dietary macronutrient intake in HIV-infected children over almost 10 years.

Inclusion Criteria:

HIV-infected individuals between three years and 20 years of age
Eating exclusively by mouth
Must not have been given megestrol acetate in the 90 days before enrollment.

Exclusion Criteria:

Data from visits at which measurements of kilocalories, carbohydrate, fat, protein, weight, height, triceps skinfold thickness and mid-arm circumference were not made were excluded.

Description of Study Protocol:

Recruitment: HIV-infected children were enrolled in a prospective, longitudinal study on growth and nutrition at the Children's Hospital AIDS Program, Boston, MA and the University of Rochester Pediatric HIV Program, Rochester, NY. Recruitment methods not described.
Design: Longitudinal study
Blinding used: Not applicable
Intervention: Not applicable.

Statistical Analysis

Sex-specific initial and final means or proportions and time trends in macronutrient intakes were estimated with regression analyses
The regression model allowed each treatment center to have an additive (main) effect on the estimated mean or proportion to account for systematically higher or lower outcomes at one center over the entire study period as a result of differences in the populations served
The Simes test of the joint null hypothesis of no center interactions in our regression model for all outcomes was done using the 21 P-values from the 3-df generalized score tests for each outcome.

Data Collection Summary:

Timing of Measurements

HIV-infected children underwent periodic longitudinal nutritional assessments between 1995 and 2004
Data were collected at scheduled clinical care visits to each center's program, typically every three to six months.

Dependent Variables

Macronutrient intake
Registered dietitians conducted dietary assessment interviews with each child and their primary caretaker using open-ended questions about meal timing, food selection and portion size
Total calorie and macronutrient intakes were calculated using nutrient analysis software
Height, weight, mid-arm circumference and triceps skinfold thickness measured by registered dietitians.

Independent Variables

HIV infection.

Control Variables

Center
Sex
Years since the beginning of the study
Interaction between years and sex.

Description of Actual Data Sample:

Initial N: 86 enrolled from Boston, 30 from Rochester
Attrition (final N): 49 males submitted 330 nutritional records, 67 females submitted 411 records
Age: Mean age, 6.6 years for Boston cohort, 8.5 years for Rochester cohort
Ethnicity: Approximately 50% were black, non-Hispanic.

Other Relevant Demographics

24% in the Boston cohort had been exposed to highly active antiretroviral therapy (HAART)
40% in the Rochester cohort had been exposed to HAART.

Location

Boston, MA and Rochester, NY.

Summary of Results:

Key Findings

Mean height and weight Z-scores were both less than normal in males
Mean height Z-score was less than normal in females
Males consumed an additional 22% of the estimated energy requirement for the ideal weight per day (P=0.008)
Calorie intake exceeded the estimated energy requirement for ideal body weight in 1995 in 62% of males and 39% of females and decreased by 3% of the estimated energy requirement per year in males (P=0.02) and by 2% in females (P=0.004)
In 2004, calorie intake still remained more than 19% above the estimated energy requirement in both groups
Protein intake was nearly 400% of the recommended dietary allowance for ideal body weight in 1995 among both males and females and decreased by 13% of the Recommended Dietary Allowance per year for males (P=0.001) and by 21% per year for females (P<0.001).
However, daily protein intake still exceeded the RDA by more than 60% in both groups in 2004
Females consumed more energy from carbohydrates (P=0.05) and sugar (P=0.10) and less from monounsaturated (P=0.04), polyunsaturated (P=0.05), saturated (P=0.03) and total (P=0.10) fat in 2004 than in 1995
For males, the mean percentages of energy derived from carbohydrate, sugar and protein remained within the recommended ranges at the end of the study
On average, cholesterol consumption in the females remained less than the USDA guideline, but fiber consumption remained inadequate.

Author Conclusion:

Current evidence indicates that HAART and possibly HIV infection itself, independently increases the risk of cardiovascular disease through metabolic complications in HIV-infected individuals
Although there is not yet a cure for HIV or an alternative to critical antiretroviral therapy, diet is a potentially modifiable factor that can alter metabolic risk for children with HIV infection
Given the early dietary trends observed in this study, continued monitoring of calorie and carbohydrate intakes is essential to avoid future increases in adiposity that may contribute to the cardiovascular disease risk in HIV-infected children.

Funding Source:

Government:

NIH

University/Hospital:

University of Miami Miller School of Medicine

Not-for-profit

The Green Family Foundation Initiative in Pediatric Infectious Disease and International Health

Reviewer Comments:

Small number of subjects
Recruitment methods not described
Authors note the following limitations:
- Lifestyle factors such as exercise, socioeconomic status and eating habits were not assessed, although these factors affect obesity in children and adolescents
- Center confounding was possible
- Some outcome variables had a large percentage of missing data as a result of the observational nature of the study.

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?	N/A
	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?		???
	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.)	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?	???
	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%.)	???
	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.)	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?	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?	Yes
	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?	No
	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?		???
	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)?	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?		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