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Completed

NCT Number: NCT02122224

Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory

One important factor determining school performance is the consumption of breakfast. While research has shown that older children perform better in school after consuming breakfast, there are little data for preschool-age children. Consuming breakfasts with different macro- and micronutrient contents may have different effects on performance, which may be associated with variations in satiation and satiety during and after the different breakfasts. In addition, children who consume breakfast have better diet quality than children who skip breakfast.

The investigators will conduct a community based, randomized, crossover trial in 4-5 year old children over 7 weeks to examine the short-term effect of feeding preschoolers three different intervention breakfast types: high protein, high-fiber, or high protein and high fiber compared to a usual breakfast served at the preschool. The investigators expect that the children consuming any of the three experimental breakfasts will consume less overall calories and have better diet quality and memory performance compared to children who have the usual breakfast. The investigators hypothesis is that preschoolers will experience the highest level of satiety as well as highest level of overall diet quality when they consume the combined high-protein and high-fiber based breakfast foods.

This study will be conducted at Bauer Family Resources in Lafayette as these are the sites of Head Start programs, which are preschools for children from low-income families. Children from families of low income are more likely to have poor diet quality and poor school performance compared to children from families with higher incomes. Therefore, this population is most in need of this type of intervention.

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Key information

Conditions

Lack of Satiety Body Weight Dietary Modification Memory Deficits Memory Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bauer Family Resources (Head Start)

Lafayette, Indiana, 47902, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 4-5 year old children attending Head Start centers in Lafayette, IN. Males and females of all racial and ethnic background are included.

Exclusion criteria

  • No digestive disorders, food allergies, or kidney disease. Children cannot be taking medication that would affect appetite.

Treatment and study plan

High fiber breakfast

Other

Breakfast will contain 10-11g fiber.

High Protein Breakfast

Other

Breakfast will contain 19-20g of protein.

High Protein/High Fiber Breakfast

Other

Breakfast will include 19-22g of protein and 10-12g of fiber.

Primary outcomes

  1. Change in reports of hunger/fullness_Baseline

    Time frame: Baseline

    Hunger/fullness will be assessed after breakfast and before lunch. The change in hunger ratings will provide data on how the breakfasts with different nutrient content affect hunger and fullness.

  2. Diet Quality_Baseline

    Time frame: Baseline

    Food and beverage intake will be recorded for 1 day at 5 points during the study to assess differences in diet quality and nutrient intake in response to breakfasts with different nutrient contents.

  3. Changes in memory_Baseline

    Time frame: baseline

    The novel object test will be given to children at 5 timepoints during the study (once per week at baseline, week 1, week 3, week 5 and week 7). This test will assess any changes in memory after consuming breakfasts with different nutrient content.

  4. Change in reports of hunger/fullness_Week 3

    Time frame: Week 3

    Hunger/fullness will be assessed after breakfast and before lunch. The change in hunger ratings will provide data on how the breakfasts with different nutrient content affect hunger and fullness.

  5. Change in reports of hunger/fullness_Week 5

    Time frame: Week 5

    Hunger/fullness will be assessed after breakfast and before lunch. The change in hunger ratings will provide data on how the breakfasts with different nutrient content affect hunger and fullness.

  6. Change in reports of hunger/fullness_Week 7

    Time frame: Week 7

    Hunger/fullness will be assessed after breakfast and before lunch. The change in hunger ratings will provide data on how the breakfasts with different nutrient content affect hunger and fullness.

  7. Diet Quality_Week 1

    Time frame: Week 1

    Food and beverage intake will be recorded for 1 day at 5 points during the study to assess differences in diet quality and nutrient intake in response to breakfasts with different nutrient contents.

  8. Diet Quality_Week 3

    Time frame: Week 3

    Food and beverage intake will be recorded for 1 day at 5 points during the study to assess differences in diet quality and nutrient intake in response to breakfasts with different nutrient contents.

  9. Diet Quality_Week 5

    Time frame: Week 5

    Food and beverage intake will be recorded for 1 day at 5 points during the study to assess differences in diet quality and nutrient intake in response to breakfasts with different nutrient contents.

  10. Diet Quality_Week 7

    Time frame: Week 7

    Food and beverage intake will be recorded for 1 day at 5 points during the study to assess differences in diet quality and nutrient intake in response to breakfasts with different nutrient contents.

  11. Changes in memory_Week 1

    Time frame: Week 1

    The novel object test will be given to children at 5 timepoints during the study (once per week at baseline, week 1, week 3, week 5 and week 7). This test will assess any changes in memory after consuming breakfasts with different nutrient content.

  12. Changes in memory_Week 3

    Time frame: Week 3

    The novel object test will be given to children at 5 timepoints during the study (once per week at baseline, week 1, week 3, week 5 and week 7). This test will assess any changes in memory after consuming breakfasts with different nutrient content.

  13. Changes in memory_Week 5

    Time frame: Week 5

    The novel object test will be given to children at 5 timepoints during the study (once per week at baseline, week 1, week 3, week 5 and week 7). This test will assess any changes in memory after consuming breakfasts with different nutrient content.

  14. Changes in memory_Week 7

    Time frame: Week 7

    The novel object test will be given to children at 5 timepoints during the study (once per week at baseline, week 1, week 3, week 5 and week 7). This test will assess any changes in memory after consuming breakfasts with different nutrient content.

Secondary outcomes

  1. Changes in weight/body fat_Baseline

    Time frame: Baseline

    This will be done to assess any changes in weight/body fat during the study. Anthropometrics will be done once during baseline, week 1, week 3, week 5 and week 7.

  2. Assessing children's usual breakfast habits

    Time frame: Baseline

    A survey will be given to families asking questions about their child and families usual breakfast habits. This will be utilized to control for any fluctuations in breakfast consumption seen during the study.

  3. Changes in weight/body fat_Week 1

    Time frame: Week 1

    This will be done to assess any changes in weight/body fat during the study. Anthropometrics will be done once during baseline, week 1, week 3, week 5 and week 7.

  4. Changes in weight/body fat_Week 3

    Time frame: Week 3

    This will be done to assess any changes in weight/body fat during the study. Anthropometrics will be done once during baseline, week 1, week 3, week 5 and week 7.

  5. Changes in weight/body fat_Week 5

    Time frame: Week 5

    This will be done to assess any changes in weight/body fat during the study. Anthropometrics will be done once during baseline, week 1, week 3, week 5 and week 7.

  6. Changes in weight/body fat_Week 7

    Time frame: Week 7

    This will be done to assess any changes in weight/body fat during the study. Anthropometrics will be done once during baseline, week 1, week 3, week 5 and week 7.

  7. Sleep habits_Baseline

    Time frame: Baseline

    Parents will rate how their children slept the night before the memory test to control for any memory changes that might occur as a result of sleep changes.

  8. Sleep habits_Week 1

    Time frame: Week 1

    Parents will rate how their children slept the night before the memory test to control for any memory changes that might occur as a result of sleep changes.

  9. Sleep habits_Week 3

    Time frame: Week 3

    Parents will rate how their children slept the night before the memory test to control for any memory changes that might occur as a result of sleep changes.

  10. Sleep habits_Week 5

    Time frame: Week 5

    Parents will rate how their children slept the night before the memory test to control for any memory changes that might occur as a result of sleep changes.

  11. Sleep habits_Week 7

    Time frame: Week 7

    Parents will rate how their children slept the night before the memory test to control for any memory changes that might occur as a result of sleep changes.

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 24, 2014
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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