EAL

H/A: Monitoring of Food Intake (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

Gain an understanding of the incidence and nature of feeding difficulties in young children infected or affected by HIV infection and look for relationships between feeding difficulties and growth, development and environmental factors.

Inclusion Criteria:

Children under five years of age who had been exposed to HIV infection and seen by the pediatric HIV service at St. Mary's Hospital.

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment

Recruited parents with a child less than five years old being seen by the pediatric HIV service at St. Mary's Hospital.

Design

Case-Control Study

Blinding used

Not applicable

Intervention

Screening over a nine-month period which included a clinical assessment and home visit by a senior dietitian and clinical psychologist.

Statistical Analysis

Did not mention however, based on tables, Chi test and T-test were used.

Data Collection Summary:

Timing of Measurements

Screening took place over a nine-month period in 1993/1994

Dependent Variables

Feeding history: Feeding behaviors and parental concerns over eating or mealtimes were assessed by questionnaire
Food intake: Three-day food diary
Growth: Measured height and weight
Developmental assessments: Bayley Scales of Infant Development and McCarthy Scales of Children's Abilities
Immune function: CD4 count and blood culture data.

Independent Variables

HIV infection

Control Variables

Description of Actual Data Sample:

Initial N

42 children (26 HIV positive, 16 HIV negative)

Attrition (final N)

As above

Age

Infected group (HIV positive) 32.8 months (range five-58 months); Uninfected group (HIV negative) 27.9 months (range 11-48 months).

Ethnicity

Infected group: 21 African, two United Kingdom, three other; Uninfected group: 11 African, three United Kingdom, two other.

Other relevant demographics

Infected group: 56% males; Uninfected group: 42% males

Anthropometrics

Cases and controls were matched. There were no statistically significant differences between the background factors in the two groups but there were slightly more girls in the infected group and more single parent families in the uninfected group.

Location

St. Mary's Hospital, London, United Kingdom. Home visit performed also.

Summary of Results:

Variables	Infected Group (n=26)	Uninfected Group (n=16)	Statistical Significance of Group Difference
Parental concerns over feeding	50%	13%	P<0.05
Height and weight less than the 10th percentile	weight-eight children height-nine	weight-two height-zero	P<0.05
Motor scale quotients for children less than 30 months (Bayley Scales of Infant Development)	Mean=75.8 (n=13)	Mean=92.9 (n=10)	P<0.0025

Other Findings

Half of the HIV-infected children were reported with serious feeding problems, significantly higher than in the uninfected group
More of the children in the HIV-infected group were found to have poorer growth and developmental weaknesses than in the uninfected group
More of the children taking AZT had weights less than the 10th percentile (P<0.01)
11 of the infected group and four of the uninfected group had daily energy intakes less than the Estimated Average Requirement calculated on actual body weights.

Author Conclusion:

Early monitoring of feeding behaviors, daily routines and food intake together with systematic growth and developmental measures are important for the care and management of HIV-infected children.

Funding Source:

University/Hospital:

St. Mary's Hospital, London, UK

Reviewer Comments:

Small sample size; 26 in HIV-infected group, 16 in uninfected group
Uninfected children lived in a household with an infected caregiver or parent who may have had health issues which could affect access or availability to food
Majority of children were of African background?foods familiar to African women may not be used or available in the United Kingdom. Also, some ethnic foods eaten were not in the dietary analysis database so alternative foods had to be substituted.

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)	Yes
	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)	Yes

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?		No
	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?	No
	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.)	???
	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?	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.)	No
	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?	???
	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?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	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?		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?	???
	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?	No
	8.2.	Were correct statistical tests used and assumptions of test not violated?	???
	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?	No
	10.2.	Was the study free from apparent conflict of interest?	Yes