Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory

Study Overview
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Brief Summary
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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.

Conditions
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Lack of Satiety, Dietary Modification, Memory Deficits, Obesity

Intervention / Treatment
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* Other: High fiber breakfast
* Other: High Protein Breakfast
* Other: High Protein/High Fiber Breakfast


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Groups will rotate through each of the 3 intervention breakfasts as well as the usual breakfast supplied at the preschool for a total of 4 weeks. | Other: High fiber breakfast<br>* Breakfast will contain 10-11g fiber.<br>Other: High Protein Breakfast<br>* Breakfast will contain 19-20g of protein.<br>Other: High Protein/High Fiber Breakfast<br>* Breakfast will include 19-22g of protein and 10-12g of fiber.<br>|
| Experimental: Group 2<br>Groups will rotate through each of the 3 intervention breakfasts as well as the usual breakfast supplied at the preschool for a total of 4 weeks. | Other: High fiber breakfast<br>* Breakfast will contain 10-11g fiber.<br>Other: High Protein Breakfast<br>* Breakfast will contain 19-20g of protein.<br>Other: High Protein/High Fiber Breakfast<br>* Breakfast will include 19-22g of protein and 10-12g of fiber.<br>|
| Experimental: Group 3<br>Groups will rotate through each of the 3 intervention breakfasts as well as the usual breakfast supplied at the preschool for a total of 4 weeks. | Other: High fiber breakfast<br>* Breakfast will contain 10-11g fiber.<br>Other: High Protein Breakfast<br>* Breakfast will contain 19-20g of protein.<br>Other: High Protein/High Fiber Breakfast<br>* Breakfast will include 19-22g of protein and 10-12g of fiber.<br>|
| Experimental: Group 4<br>Groups will rotate through each of the 3 intervention breakfasts as well as the usual breakfast supplied at the preschool for a total of 4 weeks. | Other: High fiber breakfast<br>* Breakfast will contain 10-11g fiber.<br>Other: High Protein Breakfast<br>* Breakfast will contain 19-20g of protein.<br>Other: High Protein/High Fiber Breakfast<br>* Breakfast will include 19-22g of protein and 10-12g of fiber.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in reports of hunger/fullness_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. | Baseline | 
| Diet Quality_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. | Baseline | 
| Changes in memory_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. | baseline | 
| Change in reports of hunger/fullness_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. | Week 3 | 
| Change in reports of hunger/fullness_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. | Week 5 | 
| Change in reports of hunger/fullness_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. | Week 7 | 
| Diet Quality_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. | Week 1 | 
| Diet Quality_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. | Week 3 | 
| Diet Quality_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. | Week 5 | 
| Diet Quality_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. | Week 7 | 
| Changes in memory_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. | Week 1 | 
| Changes in memory_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. | Week 3 | 
| Changes in memory_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. | Week 5 | 
| Changes in memory_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. | Week 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in weight/body fat_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. | Baseline | 
| Assessing children's usual breakfast habits | 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. | Baseline | 
| Changes in weight/body fat_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. | Week 1 | 
| Changes in weight/body fat_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. | Week 3 | 
| Changes in weight/body fat_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. | Week 5 | 
| Changes in weight/body fat_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. | Week 7 | 
| Sleep habits_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. | Baseline | 
| Sleep habits_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. | Week 1 | 
| Sleep habits_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. | Week 3 | 
| Sleep habits_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. | Week 5 | 
| Sleep habits_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. | Week 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fiber, satiety, satiation, diet quality, memory, obesity, protein