Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory

Not Applicable

Completed

• Conditions: Dietary Modification; Memory Deficits; Lack of Satiety; Obesity
• Interventions: Other: High fiber breakfast; Other: High Protein Breakfast; Other: High Protein/High Fiber Breakfast

• Registration Number: NCT02122224
• Lead Sponsor: Purdue University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-23
• Study First Posted: 2014-04-24
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-09
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 3	High Protein/High Fiber Breakfast	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.
Group 1	High Protein Breakfast	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.
Group 1	High Protein/High Fiber Breakfast	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.
Group 4	High fiber breakfast	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.
Group 4	High Protein Breakfast	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.
Group 2	High fiber breakfast	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.
Group 3	High fiber breakfast	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.
Group 3	High Protein Breakfast	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.
Group 1	High fiber breakfast	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.
Group 2	High Protein Breakfast	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.
Group 2	High Protein/High Fiber Breakfast	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.
Group 4	High Protein/High Fiber Breakfast	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.

Primary Outcome Measures

Name	Time	Method
Change in reports of hunger/fullness_Baseline	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.
Diet Quality_Week 5	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.
Changes in memory_Week 5	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.
Diet Quality_Week 7	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.
Changes in memory_Week 1	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.
Diet Quality_Week 3	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.
Changes in memory_Week 3	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.
Diet Quality_Baseline	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.
Change in reports of hunger/fullness_Week 3	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.
Change in reports of hunger/fullness_Week 7	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.
Diet Quality_Week 1	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.
Changes in memory_Baseline	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.
Change in reports of hunger/fullness_Week 5	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.
Changes in memory_Week 7	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 Outcome Measures

Name	Time	Method
Changes in weight/body fat_Week 3	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.
Sleep habits_Baseline	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.
Changes in weight/body fat_Week 1	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.
Assessing children's usual breakfast habits	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.
Changes in weight/body fat_Week 5	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.
Sleep habits_Week 7	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.
Changes in weight/body fat_Week 7	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.
Changes in weight/body fat_Baseline	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.
Sleep habits_Week 1	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.
Sleep habits_Week 3	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.
Sleep habits_Week 5	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.

Trial Locations

Locations (1)

Bauer Family Resources (Head Start); 🇺🇸 Lafayette, Indiana, United States