EAL

H/A: Body Composition Measurement (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To assess the anthropometric measurements and self-reported symptoms of body habitus changes of HIV seronegative and seropositive injection drug users.

Inclusion Criteria:

Subjects recruited between 1999 to 2001. Needed to be part of the ALIVE (AIDS Linked to Intravenous Experiences) follow-up program.
HIV-seropositive both under treatment and not under treatment.

Exclusion Criteria:

None specified.

Description of Study Protocol:

Recruitment

Recruited at the regular six-month follow-up, immediately following the participants' ALIVE visit.

Design

Cross-sectional analysis of a cohort study. Sub-study assessments took place immediately following the regular ALIVE follow-up visit.

Statistical Analysis

Demographic characteristics and body habitus symptoms were reported as percentages within each group
Anthropometric measurements were reported as means
Differences in the proportions between groups were expressed as chi-square and P-values
A generalized linear model was used to obtain univariate means and to adjust for co-variates.

Data Collection Summary:

Timing of Measurements

All measurements were obtained at the end of the participants' usual six-month follow-up visit of the ALIVE program.

Dependent Variables

Body habitus symptoms
Anthropometric measurements: Skinfolds (thigh, arm, waist, hip), body fat percentage (skinfolds, BIA), fat-free mass percentage (skinfolds, BIA), circumference ratios (waist:thigh, waist:arm, waist:hip), BMI (underweight, normal weight, overweight and obese).

Independent Variables

HIV-seropositive injection drug users, both treated and non-treated
HIV-seronegative injection drug users.

Control Variables

Age
Gender
Education
Recent injection drug use.

Description of Actual Data Sample:

Initial N: 320 subjects, approximately 70% men and approximately 30% women
Attrition (final N): 313 subjects; 100 HIV-seronegative, 213 HIV-seropositive.

Age and Ethnicity

HIV-seronegative: Age, 46.29 years; 97%, African American; 2%, Hispanic; 1%, White
HIV-seropositive, no treatment: Age, 40.75 years; 96.15%, African American; 1.28%, Hispanic; 2.56%, White
HIV-seropositive, HAART: Age, 44.66 years; 93.98%, African American; 3.01%, Hispanic; 3.01%, White.

Other Relevant Demographics

Illicit drug use in the last six months:

HIV-seronegative: 38.78%.
HIV-seropositive, no treatment: 53.16%.
HIV-seropositive, HAART: 40.91%.

Location

United States.

Summary of Results:

Other Findings

Participants who reported lipoatrophy in body parts had consistently lower anthropometric measurements and those reporting adiposity had correspondingly higher anthropometric measurements than participants who did not report these changes
Peripheral lipoatrophy was more common among all HIV-seropositive than HIV-seronegative participants; however, it was not associated with highly active antiretroviral therapy (39% HIV-seronegatives, 58% HIV-seropositive not receiving HIV treatment, 49% HAART, P=0.04)
Central adiposity was more common among HAART (52%) than No Treatment (26.6%) and HIV-seronegative (42%) participants (P=0.001)
However, waist circumference, while somewhat higher among HAART than No Treatment participants, did not differ significantly from HIV-seronegative participants (85.2cm HIV-seronegatives, 83.3cm No Treatment, 85.8cm HAART)
A large proportion of those who reported peripheral lipoatrophy also reported central lipoatrophy (76.9% HIV-seronegatives, 69.6% No Treatment, 66.2% HAART)
A large proportion of those who reported central adiposity also reported adiposity of the peripheral sites (88.1% HIV-seronegatives, 66.7% No Treatment, 74.3% HAART)
The combination of lipoatrophy and adiposity was associated with HAART treatment (6% HIV-seronegatives, 3% No Treatment, 16% HAART, P=0.002), but may be driven by the association with adiposity
Those that had injected in the last six months had smaller anthropometric measurements than those that had not in both the seropositive and seronegative group
Thigh circumference was smaller among the No Treatment group than the HAART (P=0.03) as well as the HIV-seronegative group (P=0.01)
Arm circumference was smaller in both of the seropositive groups than the seronegative group (HAART P=0.01, No Treatment P=0.03)
Hip circumference was smaller in the No Treatment participants than the HIV-seronegative group (P=0.02)
When adjusted for BMI, the arm and thigh differences were of greater statistical significance. Also the hip circumference was less for both the No Treatment (P=0.003) and the HAART group (P=0.03) than the seronegative group.
The waist circumference was greater in the HAART group than the No Treatment group, which indicated abdominal adiposity but this relationship was not significant
Triceps skinfold was less for the both the No Treatment (P=0.01) and HAART group (P=0.03) than the seronegative group. When adjusted for BMI, all skinfolds were significantly less for the No Treatment group than the seronegative group. All skinfold measurements were similar between the HAART group and the No Treatment group.

Author Conclusion:

In summary, we found that among injection drug users, anthropometric measurements were associated with HIV disease but not with HAART treatment. Self-reported central adiposity but not peripheral lipoatrophy was associated with HAART treatment, especially among participants with recent injection drug use. The mixed syndrome or combination of central adiposity and peripheral lipoatrophy was also associated with HAART treatment, but may be driven by the association with adiposity. Most of the lipoatrophy reported was not limited to peripheral sites and adiposity was not limited to central sites. We also found that participants who reported lipoatrophy in one or more body parts had corresponding lower anthropometric measurements and those who reported central adiposity had corresponding higher anthropometric measurements than participants not reporting such a change. We are currently following the participants to determine if self-reported changes will result in measurable changes. In the meantime, these data suggest validity of self-reports for body habitus changes among injection drug users.

Funding Source:

Not-for-profit

Foundation associated with industry:

Reviewer Comments:

Authors note the following limitations:

Measurements were limited to circumferences and skinfolds
Body changes were self-reported
Sample sizes for analyses were too small for meaningful interpretations.

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?		???
	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?	???
	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.)	???
	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?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	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?	No
	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?	Yes
	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?	Yes
	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?	???
	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)?	Yes
	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