EAL

AWM: Nutrition Education (2006)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To compare use of food labels before and after implementation of new FDA regulations in 1994.

Inclusion Criteria:

Adults 18 and older.

Exclusion Criteria:

Not specifically mentioned.

Description of Study Protocol:

Recruitment

Data from Washington State Cancer Risk Behavior Survey. Telephone numbers purchased from GENESYS Sampling Systems.

Design

Cross-sectional study.

Blinding used (if applicable)

Not applicable.

Intervention (if applicable)

Random-digit dial surveys in 1993 and 1996.

Statistical Analysis

All results are adjusted for sampling probability and to the intercensal estimates of the age-, sex- and county-specific Washington State population to be representative of the state's population. Statistical tests based on weighted data, with the weights standardized so that the sum of the weights equaled the number of persons interviewed. Chi-square statistics were used to test differences between 1993 and 1996.

Data Collection Summary:

Timing of Measurements

Telephone surveys in 1993 and 1996. 14 call attempts made within 1 month and an additional 11 attempts made 3 months later if necessary. Effectiveness rates of surveys were 61.1% in 1993 and 63.5% in 1996.

Dependent Variables

Attitudes and behavior related to cancer risk (diet, smoking, screening)
Nutrition label use: how often labels used when purchasing packaged food, did labels give desired info, how often respondents looked for 14 types of info on labels, barriers to label use

Independent Variables

Demographic characteristics

Control Variables

Description of Actual Data Sample:

Initial N: 1001 surveyed in 1993 (44.8% male), 1450 in 1996 (40.5% male).

Attrition (final N): See above

Age: 1993: mean age 44.8 years, 1996: 44.1 years

Ethnicity: 1993: 90.7% White, 1996: 89.9% White

Other relevant demographics:

Anthropometrics:

Location: Washington State

Summary of Results:

Other Findings

After implementation of the new regulations, usual label use increased significantly, by 8.5% in women and 11.3% in men (both P < 0.01).

There was a significant increase in those reporting they usually found info they were seeking (46.2% to 62.4% in women, and 42.0% to 58.4% in men, both P < 0.001).

There were significant increases in the percentage of respondents looking for information on calories (P < 0.001), serving size (P < 0.001), fat (P < 0.001), vitamins (P = 0.03), cholesterol (P = 0.05)and fiber (P < 0.01). There were no changes in the percentages of those looking for info on salt and chemical additives.

In both years, about 25% of residents were not interested in using labels. Principal reasons for not using labels, "takes too much time", "too hard to understand", and "print too small to read", decreased significantly by approximately 10% and these decreases tended to be larger among those under age 60.

Author Conclusion:

In summary, we found evidence of modest, positive impacts of new food labels on use, barriers to use, and satisfaction. It is important to note that the percentages of residents who never used labels did not change, and that 70% of adults still want labels to be easier to understand. The impact of the NLEA could be enhanced by further label modifications to make labels easier to understand and by programs to help consumers, especially older and less well educated consumers, interpret label information.

Funding Source:

Government:

NIH

Reviewer Comments:

Survey not tested for reliability or validity. Not necessarily representative of US population.

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?	???
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)	N/A
	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.)	No
	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?		N/A
	4.1.	Were follow-up methods described and the same for all groups?	N/A
	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%.)	N/A
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	N/A
	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?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	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?	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?	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?		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