EAL

MHFS: Food Safety (2012-2013)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To determine whether mothers learn about proper handling of infant formula from health professionals and package-label information.
To determine mothers' beliefs about the safety of infant formula and the importance of following safe-storage directions, the percentage of mothers who fail to follow each of the four safe formula-handling practices and the maternal characteristics associated with lack of adherence to these practices.

Inclusion Criteria:

Adult mothers of healthy term singletons
Data taken from the 2005 to 2007 Infant Feeding Practices Study II (IFPS II)
The cohort of mothers for this analysis consisted of IFPS II participants who reported that their infant was fed any formula in the previous two weeks on four questionnaires sent when the infant was between two and nine months old.

Exclusion Criteria:

Not described.

Description of Study Protocol:

Recruitment

Mothers were from the 2005 to 2007 Infant feeding practices study II.

Design

Cross-sectional analysis.

Statistical Analysis

SAS software was used to analyze the data cross-sectionally by using frequency procedures
16 multiple logistic regression models were used to evaluate whether maternal characteristics were independently associated with the likelihood that the mothers of infants in each of the four age groups did not follow each of the four safe-use recommendations described previously
Because of some missing data, the sample sizes for logistic regression models fell from 1,527 to 1,336 for the 1.5- to 4.5-month data, from 1,392 to 972 for the more-than-4.5- to 6.5-month data, from 1,364 to 911 for the more-than-6.5- to 8.5-month data and from 1,323 to 860 for the more-than-8.5- to 10.5-month data.

Data Collection Summary:

Timing of Measurements

Mothers were asked to report what they were feeding their infants on one set of questionnaires and then asked whether she was feeding formula on subsequent sets of questionnaires.

Dependent Variables

Questionnaires measured whether or not mothers were feeding formula and at what ages
The age groups and sample sizes of formula feeding mothers for the two- , five- , seven- and nine-month questionnaire data were:
- 1.5 to 4.5 months (N=1,527)
- More than 4.5 to 6.5 months (N=1,392)
- More than 6.5 to 8.5 months (N=1,364)
- More than 8.5 to 10.5 months (N=1,323).

Independent Variables

Mothers participating in the 2005 to 2007 Infant Feeding Practices Study II.

Description of Actual Data Sample:

Initial N:
- 1,527 formula-feeding mothers of two-month-old infants
- 1,392 formula-feeding mothers of five-month-old infants
- 1,364 formula-feeding mothers of seven-month-old infants
- 1,323 formula-feeding mothers of nine-month-old infants
Attrition (final N):
- 1527 formula-feeding mothers of two-month-old infants
- 1392 formula-feeding mothers of five-month-old infants
- 1364 formula-feeding mothers of seven-month-old infants
- 1,323 formula-feeding mothers of nine-month-old infants
Other relevant demographics: The number of mothers who reported feeding their infant formula declined throughout the study as a result of diminishing survey response rates which were 83% form the month two questionnaire but dropped to 67% for the month nine questionnaire
Location: College Park, Maryland and Atlanta, Georgia.

Summary of Results:

Key Findings

The majority of formula-feeding mothers did not receive instruction on formula preparation (77%) or storage (73%) from a health professional
30% did not read some of the safe-use directions on the formula package label
38% thought that both powdered and ready-to-feed formula were unlikely to contain germs and 85% believed that following safe-storage directions were very important
Among the mothers of the youngest infants analyzed, 55% did not always wash their hands with soap before preparing infant formula
32% did not adequately wash bottle nipples between uses
35% heated formula bottles in a microwave oven
6% did not always discard formula left standing for more than two hours
The prevalence of these unsafe practices was similar among mothers of older infants. No consistent pattern of maternal characteristics was associated with unsafe practices.

Author Conclusion:

Many mothers do not follow safe practices when preparing infant formula. The results from this analyses of IFPS II data suggest a need for additional research on why caregivers may not follow recommendations for safe infant formula handling. The results of such research could help to identify ways of increasing compliance with the recommendations to help protect infants.

Funding Source:

Government:

Food and Drug Administration, CDC and Office of Women's Health, National Institutes of Health

Reviewer Comments:

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?	No
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	No
	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.)	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?		N/A
	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?	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?		N/A
	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?	N/A
	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?	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?	Yes
	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?	No
	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