search
Back to results

Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory

Primary Purpose

Lack of Satiety, Dietary Modification, Memory Deficits

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High fiber breakfast
High Protein Breakfast
High Protein/High Fiber Breakfast
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lack of Satiety focused on measuring satiety, satiation, diet quality, memory, obesity, protein, fiber

Eligibility Criteria

4 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bauer Family Resources (Head Start)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 22, 2014
Last Updated
January 9, 2018
Sponsor
Purdue University
search

1. Study Identification

Unique Protocol Identification Number
NCT02122224
Brief Title
Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lack of Satiety, Dietary Modification, Memory Deficits, Obesity
Keywords
satiety, satiation, diet quality, memory, obesity, protein, fiber

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 4
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
High fiber breakfast
Intervention Description
Breakfast will contain 10-11g fiber.
Intervention Type
Other
Intervention Name(s)
High Protein Breakfast
Intervention Description
Breakfast will contain 19-20g of protein.
Intervention Type
Other
Intervention Name(s)
High Protein/High Fiber Breakfast
Intervention Description
Breakfast will include 19-22g of protein and 10-12g of fiber.
Primary Outcome Measure Information:
Title
Change in reports of hunger/fullness_Baseline
Description
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.
Time Frame
Baseline
Title
Diet Quality_Baseline
Description
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.
Time Frame
Baseline
Title
Changes in memory_Baseline
Description
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.
Time Frame
baseline
Title
Change in reports of hunger/fullness_Week 3
Description
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.
Time Frame
Week 3
Title
Change in reports of hunger/fullness_Week 5
Description
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.
Time Frame
Week 5
Title
Change in reports of hunger/fullness_Week 7
Description
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.
Time Frame
Week 7
Title
Diet Quality_Week 1
Description
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.
Time Frame
Week 1
Title
Diet Quality_Week 3
Description
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.
Time Frame
Week 3
Title
Diet Quality_Week 5
Description
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.
Time Frame
Week 5
Title
Diet Quality_Week 7
Description
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.
Time Frame
Week 7
Title
Changes in memory_Week 1
Description
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.
Time Frame
Week 1
Title
Changes in memory_Week 3
Description
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.
Time Frame
Week 3
Title
Changes in memory_Week 5
Description
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.
Time Frame
Week 5
Title
Changes in memory_Week 7
Description
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.
Time Frame
Week 7
Secondary Outcome Measure Information:
Title
Changes in weight/body fat_Baseline
Description
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.
Time Frame
Baseline
Title
Assessing children's usual breakfast habits
Description
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.
Time Frame
Baseline
Title
Changes in weight/body fat_Week 1
Description
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.
Time Frame
Week 1
Title
Changes in weight/body fat_Week 3
Description
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.
Time Frame
Week 3
Title
Changes in weight/body fat_Week 5
Description
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.
Time Frame
Week 5
Title
Changes in weight/body fat_Week 7
Description
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.
Time Frame
Week 7
Title
Sleep habits_Baseline
Description
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.
Time Frame
Baseline
Title
Sleep habits_Week 1
Description
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.
Time Frame
Week 1
Title
Sleep habits_Week 3
Description
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.
Time Frame
Week 3
Title
Sleep habits_Week 5
Description
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.
Time Frame
Week 5
Title
Sleep habits_Week 7
Description
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.
Time Frame
Week 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sibylle Kranz, PhD, RD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bauer Family Resources (Head Start)
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47902
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28077732
Citation
Kranz S, Brauchla M, Campbell WW, Mattes RD, Schwichtenberg AJ. High-Protein and High-Dietary Fiber Breakfasts Result in Equal Feelings of Fullness and Better Diet Quality in Low-Income Preschoolers Compared with Their Usual Breakfast. J Nutr. 2017 Mar;147(3):445-452. doi: 10.3945/jn.116.234153. Epub 2017 Jan 11.
Results Reference
derived

Learn more about this trial

Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory

We'll reach out to this number within 24 hrs