EAL

H/A: Body Composition Measurement (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To characterize the body changes reported by women attending a US urban clinic, and to evaluate possible contributing factors using inexpensive methods that are readily available in clinical practice.

Inclusion Criteria:

Female gender
Age over 18 years
Documentation of HIV infection.

Exclusion Criteria:

Pregnant
New to the clinic
Lacking a documented CD4 count or viral load within the past three months.

Description of Study Protocol:

Recruitment

Convenience sample of female subjects attending the adult HIV outpatient clinic at the Johns Hopkins Hospital in Baltimore, Maryland over a two-month period from July to August of 2000. Subjects learned of the study through posted signs in the waiting room.

Design

Cross-Sectional, Descriptive Study

Blinding used

Not applicable

Intervention (if applicable)

Not applicable

Statistical Analysis

Analyses were performed to assess the associations amongst anthropometric measurements, bioelectric impedance analysis results and other potential factors associated with reported body shape changes
Univariate analyses were performed using Bartlett's test for unequal variances and T-tests for continuous variables
ANOVA for certain categorical variables with Bonferroni multiple-comparison adjustment
Chi-squares and Fisher exact coefficients for comparisons of two categorical variables
As many of the sub-categories used contained small numbers of patients, attempts to derive multivariate models based on linear and logistic regression techniques were not statistically valid.

Data Collection Summary:

Timing of Measurements

Women were evaluated by self-report, anthropometric measurements, bioelectric impedance analysis and chart review.

Dependent Variables

Body shape changes based on self-report: Overall weight and the sizes of the neck, breasts, abdomen, arms and legs
Categorized as no change, lipodystrophy, weight loss/wasting or weight gain/obesity
CD4 counts and peak HIV-RNA viral loads from medical records
Weight measured by scale
Height measured by standardized and calibrated clinic height chart
Waist size measured at umbilicus and point of greatest circumference
BMI and waist or hip ratios were calculated
Body composition measured using bioelectric impedance analysis.

Independent Variables

HIV infection
Demographic information, presence or absence of drug use and adherence with medications through questionnaire.

Control Variables

Description of Actual Data Sample:

Initial N

163 women

Attrition (final N)

161 women. One subject was excluded due to alcohol intoxication at the time of interview and another was excluded for being a pre-operative transgender male-to-female individual.

Age

Mean 39.9±7.8 years

Ethnicity

144 (89.4%) African American, 16 (9.9%) White, zero Asian and one (0.6%) other

Other relevant demographics

100 (62%) had used intravenous drugs, 40 (25%) were actively injecting drugs and 39 (24%) smoked crack
95 (59%) were on highly active antiretroviral therapy for a median period of 11.7 months (interquartile range 4.5 - 24.2 months)
Mean CD4 count: 223±16 cells/µl
HIV-1 RNA: 199,000±19,435 copies/mL.

Anthropometrics

The sample did not differ significantly from all women in the clinic at that time in racial makeup, employment level, age or mode of HIV transmission. The women in the study were less likely to have finished high school (P=0.001).

Location

Maryland

Summary of Results:

Prevalence of Self-Reported Body Changes

Variables	Prevalence (n=161)	Percentage (%)
Redistribution	6	3.7
Fat Accumulation	3	1.9
Lipoatrophy	3	1.9
Total Lipodystrophy	12	7.5
Weight Loss/Wasting	27	16.8
Obesity/Weight Gain	85	52.8
No Reported Significant Change	37	23.0

Other Findings

Since starting current HAART or in the previous year, 12 (7.4%) reported lipodystrophy changes, 85 (52.8%) weight gain, 27 (16.8%) overall weight loss and 37 (23.0%) no change
Lipodystrophy was associated with higher CD4 percentage (P=0.03), lower frequency of crack use (P=0.04) and higher educational level (P=0.03)
Weight loss correlated with longer duration of infection (P=0.01), select bioelectric impedance analysis results and increased rate of crack use (P=0.0005)
Weight gain was associated with higher fat mass (P=0.005), higher peak viral load (P=0.02) and lower rate of intravenous drug use (P=0.03).

Author Conclusion:

In our HIV-positive women, obesity and unhealthy or unintentional weight loss dwarf the problem of lipodystrophy in terms of prevalence. Among those reporting lipodystrophy, we found little significant association with demographic, health or treatment factors, although the number of subjects was relatively small and our categorization was based solely on patient report. Weight loss in this population does not appear to be either lipoatrophy or a healthy reduction of obesity, but a manifestation of HIV disease or related to illicit drug use. The most prevalent problem in our cohort was reported weight gain and measured BMIs confirming obesity. Providers who work with HIV-infected women in urban settings need to consider the full spectrum of possible changes in patients' body shapes and compositions.

Funding Source:

Industry:

Reviewer Comments:

Body shape changes based on self-report. Authors note that the categorization of body shape changes based on self-report can lead to reporting bias.

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?		No
	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?	No
	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?	???
	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?	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