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NNNS: Effect on Appetite and Food Intake (2011)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:

To examine the eating behavior of a large number of pre-school children offered chocolate-flavored (sucrose sweetened or aspartame) or plain milk at lunch.

  • Is there caloric compensation in children that drink chocolate-flavored milk vs. plain milk?
  • To examine whether aspartame-sweetened (sugar-free) chocolate milk also induced an increase in energy intake during the meal.
Inclusion Criteria:
  • Menus were sent home to parents of the day care children
  • Parents were asked to cross out any foods that the children were unable to eat
  • Only children that were able to eat all items on the menu served as subjects in this study.
Exclusion Criteria:
  • Any children that were not able to eat all items on the menu were excluded from participating
  • No other information was provided about exclusion criteria.
Description of Study Protocol:

Recruitment

  • Subjects were obtained through advertisements in the local newspaper or through letters sent home to parents by their children's day care center
  • Parents received letters explaining that the investigator was interested in studying the eating behavior of pre-school children and were asked to sign a consent form allowing their child to serve as a subject in the study.

Design

  • Crossover study
  • All subjects received each of the four menus six times and each of the three milks twice.

Blinding Used

  • Study did not mention if the children were blinded to the two chocolate milks (sucrose vs. aspartame-sweetened).

Intervention

  • Four different menus were provided six times each over 12 weeks
  • Three different milks were provided (sucrose-sweetened chocolate milk, aspartame-sweetened chocolate milk or plain milk).

Statistical Analysis

  • Multivariate ANOVAs were conducted for each food item, food energy and total energy consumed
  • Type of milk beverage, subject's age and gender and type of setting (day care or at home) were used as independent variables in the multivariate ANOVA model
  • Post-hoc analysis was conducted with Newman-Keuls to determine differences between independent variables stated above.
Data Collection Summary:

Timing of Measurements

  • Children were served lunch in home or day care centers on two days per week, over 12 weeks
  • Mid-morning snacks were provided two hours before lunch to aid in controlling appetite at lunch
  • Four different menus were served on a rotating basis: Each menu was served six times during the 12 weeks, therefore each menu was consumed with each beverage twice
  • Lunches were served on Monday and Wednesday or Tuesday and Thursday
  • Sequence of milk consumption always stayed the same (plain, sucrose-sweetened chocolate milk, aspartame-sweetened chocolate milk)
  • Children could eat as much as desired, including beverages, at each meal
  • Children were always provided with aa four-ounce beverage, a 100g main dish, 50g of vegetable, bread with margerine (Meals One through Three) or french fries (Meal Four) plus 80g of applesauce for dessert
  • Daycare staff or parents were not present during the meal; only research assistants.

Dependent Variables

  • After each meal, the amount of individual food itmes consumed by each participant was calculated by subtracting the amount remaining from the total amount of food served
  • Amount of a specific food item consumed (calculated as described above)
  • Amount of food energy consumed (not specific foods, but the total amount of calories consumed in a meal; calculated as described above)
  • Amount of energy (calories) consumed in a beverage
  • Total energy from food and beverages.

Independent Variables

  • Type of milk (sucrose sweetened chocolate milk, aspartame sweetened chocolate milk)
  • Subjects' age and gender
  • Type of setting (day care vs. at-home children).

Control Variables

  • Plain milk.
Description of Actual Data Sample:

Initial N

  • Information not provided.

Attrition (Final N)

  • 135 children (63 boys, 72 girls)
  • 89 children from day care centers (52 girls, 37 boys)
  • 46 children from private homes (19 girls, 27 boys).

Age

  • 18 to 66 months
  • 18 to 30 months (15 girls, 13 boys)
  • 31 to 42 months (21 girls, 17 boys)
  • 43 to 54 months (22 girls, 18 boys)
  • 55 to 66 months (14 girls, 15 boys).

Ethnicity

  • Information not provided.

Other Relevant Demographics

  • No information provided.

Anthropometrics

  • No anthropometric data provided on height, weight, etc.

Location

  • Not stated.
Summary of Results:

A plethora of data is provided in this manuscript. Each independent variable is expressed for each of the four meals. The results presented here are the summary of the findings with the P-values.

  • Sucrose-sweetened or aspartame-sweetened chocolate milk, compared to plain milk, had no significant effect on the consumption of other food items at the meal
  • More chocolate milk (both types) was consumed vs. plain milk during all meals (P<0.01)
  • More calories were consumed at meals with sucrose-sweetened chocolate milk, due to an increase in milk consumption (P<0.001)
  • Number of ounces of milk consumed by children were not different betwen sucrose- vs. aspartame-sweetened chocolate milk (P>0.05)
  • Significantly more milk calories were consumed with sucrose-sweetened vs aspartame-sweetened chocolate milk (P<0.05)
  • Significantly more milk calories were consumed with aspartame-sweetened chocolate milk vs. plain milk (P<0.05)
  • Children consumed significantly more energy (meals plus milk) during meals at which sucrose-sweetened milk was served than they did at meals at which aspartame-sweetened or plain milk was served (P<0.05)
  • Total energy intake was not significantly different between meals at which aspartame-sweetened or plain milk was served
  • For all meals, carbohydrate intake was significantly increased with sucrose-sweetened milk vs. aspartame-sweetened or plain milk (P<0.001)
  • Older children (55 to 66 months) consumed significantly more milk, regardless of type (P<0.01) and more total energy (P<0.01) than younger children (under 54 months)
  • No gender differences were detected (P>0.05)
  • No significant differences in food consumption between children served at home and those served at day care centers (P>0.05).
Author Conclusion:
  • Young children drink significantly more milk when it is sweetened and flavored with chocolate
  • Young children do not reduce the intake of other food items at the meal to compensate for the elevated energy intake that results from increased milk consumption
  • Young children drink significantly greater amounts of sucrose-sweetened and aspartame-sweetened milk than they did plain milk, yet the total amount of energy from meals at which aspartame-sweetened milk did not differ significantly from those meals at which plain milk was served
  • Aspartame-sweetened milk increases the intake of milk in small children without providing them with the additional calories of sucrose-sweetend milk
  • Offering high-energy, palatable drinks with meals might pre-dispose a child to chronic overeating.
Funding Source:
Reviewer Comments:
  • The primary focus of this study was not to evaluate the effects of aspartame on caloric intake. This aspect of the study was a secondary question.
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? No
  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? 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")? Yes
4. Was method of handling withdrawals described? No
  4.1. Were follow-up methods described and the same for all groups? No
  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%.) No
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? ???
  4.4. Were reasons for withdrawals similar across groups? ???
  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? No
  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? 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? N/A
  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? N/A
  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? Yes
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? 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)? No
  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