Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Purdue University
Sponsor:
Information provided by (Responsible Party):
Sibylle Kranz, Purdue University
ClinicalTrials.gov Identifier:
NCT02122224
First received: April 22, 2014
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Lack of Satiety
Dietary Modification
Memory Deficits
Obesity
Other: High fiber breakfast
Other: High Protein Breakfast
Other: High Protein/High Fiber Breakfast

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Change in reports of hunger/fullness_Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: December 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
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
Breakfast will contain 10-11g fiber.
Other: High Protein Breakfast
Breakfast will contain 19-20g of protein.
Other: High Protein/High Fiber Breakfast
Breakfast will include 19-22g of protein and 10-12g of fiber.
Experimental: Group 2
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
Breakfast will contain 10-11g fiber.
Other: High Protein Breakfast
Breakfast will contain 19-20g of protein.
Other: High Protein/High Fiber Breakfast
Breakfast will include 19-22g of protein and 10-12g of fiber.
Experimental: Group 3
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
Breakfast will contain 10-11g fiber.
Other: High Protein Breakfast
Breakfast will contain 19-20g of protein.
Other: High Protein/High Fiber Breakfast
Breakfast will include 19-22g of protein and 10-12g of fiber.
Experimental: Group 4
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
Breakfast will contain 10-11g fiber.
Other: High Protein Breakfast
Breakfast will contain 19-20g of protein.
Other: High Protein/High Fiber Breakfast
Breakfast will include 19-22g of protein and 10-12g of fiber.

  Eligibility

Ages Eligible for Study:   4 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02122224

Contacts
Contact: Mary C Brauchla, MPH 765-494-2461 mbrauchl@purdue.edu

Locations
United States, Indiana
Bauer Family Resources (Head Start) Recruiting
Lafayette, Indiana, United States, 47902
Contact: Rebecca Parker    765-477-9905    rparker@bauerfamilyresources.org   
Principal Investigator: Sibylle Kranz, PhD, RD         
Sponsors and Collaborators
Purdue University
Investigators
Principal Investigator: Sibylle Kranz, PhD, RD Purdue University
  More Information

No publications provided

Responsible Party: Sibylle Kranz, Associate Prof. Nutrition Science, Purdue University
ClinicalTrials.gov Identifier: NCT02122224     History of Changes
Other Study ID Numbers: PU-IRB1310014050, 1310014050
Study First Received: April 22, 2014
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
satiety
satiation
diet quality
memory
obesity
protein
fiber

Additional relevant MeSH terms:
Memory Disorders
Obesity
Food Habits
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Habits
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014