EAL

PWM: Foods and Nutrients (2006)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To compare the nutrient intake of children who are at risk for cardiovascular disease based on family history with those who are not at risk.

Inclusion Criteria:

Fifth grade children in schools from three Appalachian counties. Children were included if they assented to the procedures and their parents signed an informed consent.

Exclusion Criteria:

Children whose dietary records indicated energy intake less than 500 kcal or greater than 5000 kcal or whose records were incomplete due to absence, moved school, unable to read, or student identification number had errors.

Description of Study Protocol:

Recruitment

Packets were sent to parents of all fifth grade children in schools from three counties in Appalachia explaining the Coronary Artery Risk Detection in Appalachian Communities (CARDIAC) Project and study procedures.

Design

Dietary intake was measured using a youth modified FFQ. Anthropometric measurements (height, weight), blood pressure, non-fasting finger-stick total cholesterol were taken.

Statistical Analysis

Student’s t-test (compare mean nutrient intake between students who met National Cholesterol Education Program risk criteria and those who did not), chi-square analysis (compare the proportion of children in each group whose intake of nutrients met recommendations issued by the American Heart Association and Institute of Medicine).

Data Collection Summary:

Dependent Variables

Total cholesterol (non-fasting, finger-stick test)
Blood pressure (systolic & diastolic)
BMI

Independent Variables

Dietary intake (food frequency questionnaire)

Description of Actual Data Sample:

Initial N: 781

Attrition (final N): 297 (157 girls, 140 boys)

Age: Average age was 10.8±0.6 years for boys and 10.6±0.7 years for girls

Ethnicity: White

Location: West Virginia

Summary of Results:

68 (23%) children were at risk for CVD based on National Cholesterol Education Program (NCEP) guidelines.

Mean non-fasting cholesterol was significantly greater in the at-risk group compared with the not-at-risk group (4.71±0.93 mmol/L versus 4.35±0.92 mmol/L, p=0.005).

25 (37%) of at-risk students and 91 (40%) in the low-risk group had BMI greater than the 85^th percentile. Of the 34 children who had fasting lipid profiles, mean LDL was 3.34±0.58 mmol/L and dyslipidemia was diagnosed in 21 (62%).

There were no differences between groups in intake of macronutrients, fiber, cholesterol, or percentage of calories as fat. Percentages of calories as fat or saturated fat were higher than recommended for both groups. Mean intakes of vitamins and minerals met current recommendations and were not different between groups. There was no difference between groups in the proportion of children who met intake recommendations.

There was no examination of the possible association between diet variables and BMI.

Author Conclusion:

Although the dietary patterns of these children appear to be adequate in most vitamins and minerals, there are notable exceptions that may have implications for chronic disease prevention. Intakes of fat and saturated fat as a percentage of energy are still greater than recommended, and total energy intake is high. Overall, these dietary patterns are consistent with an increased risk for obesity and cardiovascular disease and likely contribute to the high incidence of both in West Virginia.

Funding Source:

Not-for-profit

Reviewer Comments:

Limitations:

Not generalizable to non-white, urban children and adolescents.
No controlling (for total energy intake, physical activity/inactivity, etc.)
Cross-sectional design.

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?		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?		Yes
	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.)	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.)	Yes
	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?	Yes
	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.)	???
	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?		???
	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?	???
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	???
	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?		???
	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?	No
	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)?	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?		???
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	No
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