<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02207049</url>
  </required_header>
  <id_info>
    <org_study_id>9564 B</org_study_id>
    <nct_id>NCT02207049</nct_id>
  </id_info>
  <brief_title>The Effect of Snack Consumption on Energy Intake in Preschoolers</brief_title>
  <official_title>The Effect of Snack Consumption on Energy Intake in Preschoolers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Tennessee, Knoxville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Tennessee, Knoxville</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot study will be to examine the influence of providing snacks on&#xD;
      consumption of overall energy intake in children aged 2-5 years in the Early Learning Center&#xD;
      (ELC) at the University of Tennessee.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Providing snacks to children is widely recommended for appetite regulation and assisting with&#xD;
      meeting nutritional guidelines.1 Currently, snacks contribute a larger portion of dietary&#xD;
      intake in children than in previous years.2,3 Additionally, observational research has found&#xD;
      that self-reported, low-nutrient-dense snack consumption, has increased among preschoolers&#xD;
      (ages 2-to-6 years) over the past 20 years, leading to an increase of total daily energy&#xD;
      intake.3 However, no experimental studies examining the influence of snack intake on energy&#xD;
      consumption in children have been conducted.2 Therefore, at this time it is not clear how&#xD;
      snacks impact appetite regulation or energy intake, especially in young children.&#xD;
&#xD;
      Thus, the purpose of this pilot study will be to examine the influence of providing snacks on&#xD;
      consumption of overall energy intake in children aged 2-5 years in the Early Learning Center&#xD;
      (ELC) at the University of Tennessee. Children will be provided with 3-to-5 ad libitum eating&#xD;
      occasions over the course of a day for three sessions. To test the effects of providing&#xD;
      snacks to preschoolers on consumption of food throughout the day, the food will be provided&#xD;
      in three ways in the three different sessions: 1) children will be provided three meals (TM);&#xD;
      2) children will be provided three meals and two snacks, with total amount of food provided&#xD;
      in the day the same as TM (M+S); and 3) children will be provided three meals and two snacks&#xD;
      with total amount provided in the meals equal to TM and total amount provided in the snacks&#xD;
      equal to M+S (TM+S).&#xD;
&#xD;
      Primary Hypothesis:&#xD;
&#xD;
      1) Energy consumed from food and beverages will be greatest during the TM+S session, followed&#xD;
      by M+S, and then TM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total calories of the food and beverages consumed.</measure>
    <time_frame>3 weeks</time_frame>
    <description>Total calories of food and beverage consumed by participants over the 3-week study (with 1 day of food and beverage per week) period will be determined by subtracting pre- and post-consumption weight of the food and beverage provided and multiplied by the energy density of each respective food and beverage.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Energy Intake</condition>
  <condition>Snacks</condition>
  <condition>Children, Preschool</condition>
  <arm_group>
    <arm_group_label>Three Meals (TM)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preschoolers will be provided their caloric needs within three meals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meal plus Snack (M+S)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preschoolers will be provided three meals and two snacks, with total amount of food provided in the day the same as the Three Meal (TM) arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Three Meal plus Snack (TM+S)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preschoolers will be provided three meals and two snacks with total amount provided in the meals equal to the Three Meal (TM) arm and total amount provided in the snacks equal to Meal plus Snacks (M+S) arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Snacking</intervention_name>
    <description>Snacks will be provided to preschoolers, either as part of total caloric needs or above total caloric needs</description>
    <arm_group_label>Meal plus Snack (M+S)</arm_group_label>
    <arm_group_label>Three Meal plus Snack (TM+S)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No Snacking</intervention_name>
    <description>Caloric needs will be provided to preschoolers within three meals</description>
    <arm_group_label>Three Meals (TM)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  3 -to- 5 years of age&#xD;
&#xD;
          -  enrolled at the Early Learning Center for the full day program&#xD;
&#xD;
          -  have guardian consent to participate&#xD;
&#xD;
          -  like the foods served&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have allergies or intolerances to the foods being served&#xD;
&#xD;
          -  not able to use a spoon&#xD;
&#xD;
          -  did not attend all feeding sessions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hollie A Raynor, PhD, RD, LDN</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tennesseem Knoxville</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Healthy Eating and Activity Laboratory</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37996</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Allen RE, Myers AL. Nutrition in toddlers. Am Fam Physician. 2006 Nov 1;74(9):1527-32.</citation>
    <PMID>17111891</PMID>
  </reference>
  <reference>
    <citation>Smith-Petersen MN, Larson CB, Cochran W. Local chemotherapy with primary closure of septic wounds by means of drainage and irrigation cannulae : M. N. Smith-Petersen MD (1886-1953), Carroll B. Larson MD, Williams Cochran MD . The 12th president of the AAOS 1943 (MNS-P). Clin Orthop Relat Res. 2008 Jan;466(1):104-12. doi: 10.1007/s11999-007-0023-4.</citation>
    <PMID>18196379</PMID>
  </reference>
  <reference>
    <citation>Ford CN, Slining MM, Popkin BM. Trends in dietary intake among US 2- to 6-year-old children, 1989-2008. J Acad Nutr Diet. 2013 Jan;113(1):35-42. doi: 10.1016/j.jand.2012.08.022.</citation>
    <PMID>23260722</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>June 17, 2023</last_update_submitted>
  <last_update_submitted_qc>June 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Tennessee, Knoxville</investigator_affiliation>
    <investigator_full_name>Hollie Raynor</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02207049
org study id: 9564 B
nct id: NCT02207049
lead sponsor: 
has dmc: No
The purpose of this pilot study will be to examine the influence of providing snacks on
      consumption of overall energy intake in children aged 2-5 years in the Early Learning Center
      (ELC) at the University of Tennessee.
Providing snacks to children is widely recommended for appetite regulation and assisting with
      meeting nutritional guidelines.1 Currently, snacks contribute a larger portion of dietary
      intake in children than in previous years.2,3 Additionally, observational research has found
      that self-reported, low-nutrient-dense snack consumption, has increased among preschoolers
      (ages 2-to-6 years) over the past 20 years, leading to an increase of total daily energy
      intake.3 However, no experimental studies examining the influence of snack intake on energy
      consumption in children have been conducted.2 Therefore, at this time it is not clear how
      snacks impact appetite regulation or energy intake, especially in young children.

      Thus, the purpose of this pilot study will be to examine the influence of providing snacks on
      consumption of overall energy intake in children aged 2-5 years in the Early Learning Center
      (ELC) at the University of Tennessee. Children will be provided with 3-to-5 ad libitum eating
      occasions over the course of a day for three sessions. To test the effects of providing
      snacks to preschoolers on consumption of food throughout the day, the food will be provided
      in three ways in the three different sessions: 1) children will be provided three meals (TM);
      2) children will be provided three meals and two snacks, with total amount of food provided
      in the day the same as TM (M+S); and 3) children will be provided three meals and two snacks
      with total amount provided in the meals equal to TM and total amount provided in the snacks
      equal to M+S (TM+S).

      Primary Hypothesis:

      1) Energy consumed from food and beverages will be greatest during the TM+S session, followed
      by M+S, and then TM.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Total calories of the food and beverages consumed.
time frame: 3 weeks
description: Total calories of food and beverage consumed by participants over the 3-week study (with 1 day of food and beverage per week) period will be determined by subtracting pre- and post-consumption weight of the food and beverage provided and multiplied by the energy density of each respective food and beverage.
arm group label: Three Meals (TM)
arm group type: Active Comparator
description: Preschoolers will be provided their caloric needs within three meals.
arm group label: Meal plus Snack (M+S)
arm group type: Active Comparator
description: Preschoolers will be provided three meals and two snacks, with total amount of food provided in the day the same as the Three Meal (TM) arm.
arm group label: Three Meal plus Snack (TM+S)
arm group type: Active Comparator
description: Preschoolers will be provided three meals and two snacks with total amount provided in the meals equal to the Three Meal (TM) arm and total amount provided in the snacks equal to Meal plus Snacks (M+S) arm.
intervention type: Behavioral
intervention name: Snacking
description: Snacks will be provided to preschoolers, either as part of total caloric needs or above total caloric needs
arm group label: Meal plus Snack (M+S)
arm group label: Three Meal plus Snack (TM+S)
intervention type: Behavioral
intervention name: No Snacking
description: Caloric needs will be provided to preschoolers within three meals
arm group label: Three Meals (TM)
criteria: 
gender: All
minimum age: 3 Years
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hollie A Raynor, PhD, RD, LDN
role: Principal Investigator
affiliation: University of Tennesseem Knoxville
facility: 
country: United States
citation: Allen RE, Myers AL. Nutrition in toddlers. Am Fam Physician. 2006 Nov 1;74(9):1527-32.
PMID: 17111891
citation: Smith-Petersen MN, Larson CB, Cochran W. Local chemotherapy with primary closure of septic wounds by means of drainage and irrigation cannulae : M. N. Smith-Petersen MD (1886-1953), Carroll B. Larson MD, Williams Cochran MD . The 12th president of the AAOS 1943 (MNS-P). Clin Orthop Relat Res. 2008 Jan;466(1):104-12. doi: 10.1007/s11999-007-0023-4.
PMID: 18196379
citation: Ford CN, Slining MM, Popkin BM. Trends in dietary intake among US 2- to 6-year-old children, 1989-2008. J Acad Nutr Diet. 2013 Jan;113(1):35-42. doi: 10.1016/j.jand.2012.08.022.
PMID: 23260722
responsible party type: Principal Investigator
investigator affiliation: The University of Tennessee, Knoxville
investigator full name: Hollie Raynor
investigator title: Professor