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HIV/AIDS

H/A: Monitoring of Food Intake (2009)

Citation:

Heller L, Fox S, Hell KJ, Church JA. Development of an instrument to assess nutritional risk factors for children infected with human immunodeficiency virus. J Am Diet Assoc. 2000;100(3): 323-329.

PubMed ID: 10719406
 
Study Design:
Cross-sectional study
Class:
D - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:

To produce a simple and effective instrument to evaluate and monitor the nutritional risk of children infected with the human immunodeficiency virus (HIV).

Inclusion Criteria:

Inclusion criteria not described.

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment

HIV-infected children were selected using quota sampling. Subjects were stratified by clinical class as defined by the Centers for Disease Control and Prevention. Recruitment methods were not described.

Design

Cross-sectional study.

Statistical Analysis

  • The severity or degree of potential nutritional risk in each section (anthropometric, biochemical, dietary intake and medical data) was graded (zero to four, zero=low risk) and summed
  • Reliability of internal consistency was determined through covariance matrices and Cronbach's alpha
  • Validity was determined through Pearson product moment correlation coefficients to measure convergent and divergent validity
  • Predictive validity was determined using analysis of variance
  • Correlation for validity was compared to six selected dependent variables: weight-for-height, weight growth velocity, lean body mass, serum albumin level, CD4+ count and quantitative plasma HIV RNA levels.
Data Collection Summary:

Timing of Measurements

The test instrument was developed in consultation with five physicians, five nutritionists and five social workers with expertise in caring for HIV-infected children. All data were retrieved from the medical record or collected at the time the subject was selected for the study.

Dependent Variables

  • Patient information was collected through medical record review for 19 sociodemographic, 10 anthropometric, four biochemical, six dietary intake and 19 medical factors
  • Sociodemographic factors: age, race, sex, mode of HIV transmission, custody status, insurance, food supplement programs, caregiver's language preference, years of US residency, HIV status, education and occupation so that socioeconomic status score could be obtained  
  • Anthropometric data: weight, height, body mass index (BMI), subcutaneous fat measurements, calculation of somatic protein stores, percentage of ideal body weight, growth velocities and history of weight loss
  • Caregivers were asked to complete a three-day diet record, which was analyzed for total energy, protein and food frequency of eight food groups (dairy, protein, grains, vitamin C-rich foods, vitamin A-rich foods, total fruits and vegetables, fats and sweets)
  • Data on use of vitamin/mineral supplements, nutrition supplements, non-traditional remedies, present medications, nutrition route, food intolerance, presence or recent history of oropharyngeal disturbances, opportunistic infections and hospitalizations were recorded  
  • Blood samples tested for CD4+ counts, serum HIV p24 antigen, plasma HIV RNA levels, serum albumin and prealbumin, iron and zinc.

Independent Variable

HIV infection in children.

 

Description of Actual Data Sample:

Initial N: 39 HIV-infected children

Attrition (final N): 39 children, 20 girls and 19 boys

Age: Range, one year to 17 years; mean, 8 years

Ethnicity: 31% white, 28% black, 38% Latino, 3% Native American

Location: Children's Hospital, Los Angeles.

 

Summary of Results:

Potential Risk Factors for Malnutrition in Children Infected with HIV

Variables

Strong alpha Marginal alpha

Weak alpha

Height-for-age

0.7238    
Weight-for-age 0.7077    
Clinical status 0.6968    
Somatic protein stores 0.6676    
Mid-arm circumference 0.6654    
Weight-for-height 0.5867    
Serum albumin level 0.5607    
Immunologic status 0.5585    
BMI 0.5527    
Energy intake 0.5213    

Opportunistic infections

0.5138 

 

 

Pain in the past 30 days   0.4702   
Adipose stores   0.4489  
Physical activity/week   0.4131  
Oropharyngeal disturbances   0.3565  
Weight growth velocity   0.3379  
Vitamin A-rich foods   0.3363  
Total fruits and vegetables   0.3305  
Hepatomegaly   0.3297  
Weight loss during past six months   0.3249  
Protein intake   0.3045  
Prealbumin level   0.3006  
Sleeping more than usual     0.2724 
Iron level     0.2475
Change in personality     0.2365
Milk products     0.2364
Grain foods     0.2194
Vitamin C-rich foods     0.2118
Hospitalizations     0.1981
Height growth velocity     0.1223
Zinc level     0.1028
Splenomegaly     0.0868
Protein intake     0.0337
Time spent eating     0.0095
Sweets intake     -0.0392
Consumption of multivitamin     -0.0603
HIV RNA level     -0.0637
Consumption of nutrition supplement     -0.1504
Total reliability     0.8471 
Adjusted total reliability     0.8781

Other Findings

Statistical analysis revealed no difference or correlation between specific sociodemographic characteristics and nutritional risk.

Of the 38 factors that were analyzed for reliability, 11 fell in the strongly reliable range: height-for-age, weight-for-age, clinical class, somatic protein stores, mid-arm circumference, weight-for-height, serum albumin, immunologic status, BMI, energy intake and opportunistic infections. 

Six of the 11 factors were anthropometric measurements, one was a biochemical factor, one was a dietary intake factor and three were medical factors.

The instrument was very reliable once the eight weakest items were removed: zinc level, splenomegaly, protein intake, time spent eating, sweets intake, consumption of multivitamin, HIV RNA level and consumption of nutrition supplement.

Author Conclusion:

Anthropometric, dietary intake and medical data were reliable indicators of nutritional risk. The entire instrument was reliable after eight of the weakest items were removed. The instrument was found to be valid and a good predictor of nutritional risk in HIV-infected children. The instrument is valuable as a means to direct treatment at sites where the services of a nutritionist are not available or where there may not be a nutritionist experienced with HIV. The instrument can be used to measure subtle changes in nutritional status as result of nutrition, psychosocial or medical interventions.

Funding Source:
Not-for-profit
T. J. Martell Foundation for Leukemia and AIDS Research
Reviewer Comments:

Small sample size. Recruitment methods and inclusion/exclusion criteria not described. Authors note that the numbers were too small to draw reliable conclusions.

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? No
  2.2. Were criteria applied equally to all study groups? N/A
  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? N/A
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) N/A
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? N/A
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) N/A
  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? 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? ???
  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.) N/A
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? ???
  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? N/A
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)? 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? No
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