<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/NCT04481776</url>
  </required_header>
  <id_info>
    <org_study_id>Bedfordshire</org_study_id>
    <nct_id>NCT04481776</nct_id>
  </id_info>
  <brief_title>Breakfast Omission and Energy Balance in Girls</brief_title>
  <official_title>Effect of Daily Breakfast Omission Versus Breakfast Consumption on Physical Activity Energy Expenditure and Energy Intake in Adolescent Girls Who Habitually Skip Breakfast: a 7-day Crossover Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bedfordshire</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bedfordshire</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a distinct lack of experimental evidence on whether breakfast consumption and&#xD;
      omission affect energy balance-related variables. This research is of particular relevance to&#xD;
      adolescent girls due to concerns of low rates of breakfast consumption and physical activity&#xD;
      in this population. This study aims to compare the effect of seven consecutive days of&#xD;
      breakfast omission with standardised breakfast consumption on free-living physical activity&#xD;
      energy expenditure, energy intake and perceived appetite and energy levels in adolescent&#xD;
      girls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Observational reports showing infrequent breakfast consumption to be associated with&#xD;
      increased adiposity and cardiometabolic disease risk in children and adolescents have fuelled&#xD;
      concerns over the low prevalence of habitual breakfast consumption among adolescents. Yet,&#xD;
      only experimental study designs can determine the causal effects of breakfast consumption on&#xD;
      health-related variables and such research has typically targeted adults. Adolescent girls&#xD;
      may respond differently to manipulations in breakfast consumption than adults because they&#xD;
      have distinct hormonal, metabolic and behavioural profiles. Further, a link between breakfast&#xD;
      and physical activity in adolescent girls has particular public health relevance because the&#xD;
      adolescent decline in both breakfast consumption frequency and physical activity is more&#xD;
      pronounced in girls than in boys. Thus, the primary aim of the current study is to use a&#xD;
      randomised, cross-over design to compare the effect of seven consecutive days of breakfast&#xD;
      omission with standardised breakfast consumption on free-living PAEE in adolescent girls. The&#xD;
      secondary aims are to examine the effects on energy intake, perceived appetite and energy&#xD;
      levels.&#xD;
&#xD;
      Using a randomized crossover design, girls aged 11-14 years will complete two, 7-day&#xD;
      conditions. A standardized breakfast will consumed every day before 09:00 in the daily&#xD;
      breakfast consumption condition. No energy-providing nutrients will consumed (i.e., only&#xD;
      water) before 10:30 in the breakfast omission condition. Combined heart rate-accelerometry&#xD;
      will be used to estimate physical activity energy expenditure and digital photography&#xD;
      complemented with written food diaries will be used to assess energy intake during each&#xD;
      condition; these data will be separated into three time segments: wake to 10:30, 10:30 to&#xD;
      15:30 and 15:30 to bed. Visual analogue scales will be used to assess perceptions of hunger,&#xD;
      fullness, tiredness and energy levels on waking and at 09:00 and 10:30. Statistical analyses&#xD;
      will be completed using condition by time of day linear mixed models.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Actual">March 15, 2019</completion_date>
  <primary_completion_date type="Actual">March 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical activity energy expenditure (kJ/day)</measure>
    <time_frame>Seven days</time_frame>
    <description>Free-living physical activity energy expenditure from sedentary, light, moderate and vigorous activities (kJ/day) assessed using combined heart rate-accelerometry across seven consecutive days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time spent in physical activity (minutes/day)</measure>
    <time_frame>Seven days</time_frame>
    <description>Time spent sedentary and in light, moderate and vigorous physical activity (minutes/day) assessed using combined heart rate-accelerometry across seven consecutive days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Energy intake (kJ/day)</measure>
    <time_frame>Four days</time_frame>
    <description>Energy intake (kJ/day) assessed using combined digital photography and food diaries across four days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carbohydrate intake (g/day)</measure>
    <time_frame>Four days</time_frame>
    <description>Carbohydrate intake (g/day) assessed using combined digital photography and food diaries across four days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat intake (g/day)</measure>
    <time_frame>Four days</time_frame>
    <description>Fat intake (g/day) assessed using combined digital photography and food diaries across four days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein intake (g/day)</measure>
    <time_frame>Four days</time_frame>
    <description>Protein intake (g/day) assessed using combined digital photography and food diaries across four days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibre intake (g/day)</measure>
    <time_frame>Four days</time_frame>
    <description>Fibre intake (g/day) assessed using combined digital photography and food diaries across four days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived hunger (mm)</measure>
    <time_frame>Four days</time_frame>
    <description>Perceived hunger (mm) assessed using 0-100 mm visual analogue scales on waking, at 09:00 and at 10:30 on four days. Higher values equate to higher hunger.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived fullness (mm)</measure>
    <time_frame>Four days</time_frame>
    <description>Perceived fullness (mm) assessed using 0-100 mm visual analogue scales on waking, at 09:00 and at 10:30 on four days. Higher values equate to higher fullness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived tiredness levels (mm)</measure>
    <time_frame>Four days</time_frame>
    <description>Perceived tiredness levels (mm) assessed using 0-100 mm visual analogue scales on waking, at 09:00 and at 10:30 on four days. Higher values equate to higher tiredness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived energy levels (mm)</measure>
    <time_frame>Four days</time_frame>
    <description>Perceived energy levels (mm) assessed using 0-100 mm visual analogue scales on waking, at 09:00 and at 10:30 on four days. Higher values equate to higher energy levels.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Adolescent Obesity</condition>
  <condition>Insulin Resistance</condition>
  <condition>Adolescent Behavior</condition>
  <arm_group>
    <arm_group_label>Breakfast consumption</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be asked to consume a standardised breakfast at home before 09:00 for seven consecutive days. The energy content of the breakfast will be 25% of individual measured resting metabolic rate. Prior to the experimental conditions, the participants will select one wholegrain, high-fibre ready-to-eat cereals (with the option of adding raisins) and fruit juice from a limited selection. Thus, breakfast composition will be controlled within participants, but not between participants to account for individual preferences. To ensure that the correct amount of each breakfast item is consumed, food items will be provided to the participants in pre-packaged containers and the participants will be provided with a marked beaker to measure their milk and juice each morning. The only exception is that parents will be asked to provide the 1.8% milk.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breakfast omission</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were asked to abstain from all energy-providing nutrients before 10:30 for seven consecutive days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breakfast consumption</intervention_name>
    <description>Standardised breakfast consumption across seven days</description>
    <arm_group_label>Breakfast consumption</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breakfast omission</intervention_name>
    <description>No breakfast consumed across seven days</description>
    <arm_group_label>Breakfast omission</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parental informed consent&#xD;
&#xD;
          -  Child assent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Health related issues identified from a health screen questionnaire that could be&#xD;
             adversely affected by participation or could affect the study outcomes (e.g.,&#xD;
             allergies to the breakfast meals, fitted with a pacemaker)&#xD;
&#xD;
          -  Unable to walk or wear a combined heart rate-accelerometer on the chest.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julia K Fruer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bedfordshire</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Bedfordshire</name>
      <address>
        <city>Bedford</city>
        <state>Bedfordshire</state>
        <zip>MK41 9EA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bedfordshire</investigator_affiliation>
    <investigator_full_name>Dr Julia Fruer</investigator_full_name>
    <investigator_title>Senior Lecturer in Health, Nutrition and Exercise</investigator_title>
  </responsible_party>
  <keyword>Breakfast</keyword>
  <keyword>Physical activity</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Appetite</keyword>
  <keyword>Sedentary</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04481776
org study id: Bedfordshire
nct id: NCT04481776
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is a distinct lack of experimental evidence on whether breakfast consumption and
      omission affect energy balance-related variables. This research is of particular relevance to
      adolescent girls due to concerns of low rates of breakfast consumption and physical activity
      in this population. This study aims to compare the effect of seven consecutive days of
      breakfast omission with standardised breakfast consumption on free-living physical activity
      energy expenditure, energy intake and perceived appetite and energy levels in adolescent
      girls.
Observational reports showing infrequent breakfast consumption to be associated with
      increased adiposity and cardiometabolic disease risk in children and adolescents have fuelled
      concerns over the low prevalence of habitual breakfast consumption among adolescents. Yet,
      only experimental study designs can determine the causal effects of breakfast consumption on
      health-related variables and such research has typically targeted adults. Adolescent girls
      may respond differently to manipulations in breakfast consumption than adults because they
      have distinct hormonal, metabolic and behavioural profiles. Further, a link between breakfast
      and physical activity in adolescent girls has particular public health relevance because the
      adolescent decline in both breakfast consumption frequency and physical activity is more
      pronounced in girls than in boys. Thus, the primary aim of the current study is to use a
      randomised, cross-over design to compare the effect of seven consecutive days of breakfast
      omission with standardised breakfast consumption on free-living PAEE in adolescent girls. The
      secondary aims are to examine the effects on energy intake, perceived appetite and energy
      levels.

      Using a randomized crossover design, girls aged 11-14 years will complete two, 7-day
      conditions. A standardized breakfast will consumed every day before 09:00 in the daily
      breakfast consumption condition. No energy-providing nutrients will consumed (i.e., only
      water) before 10:30 in the breakfast omission condition. Combined heart rate-accelerometry
      will be used to estimate physical activity energy expenditure and digital photography
      complemented with written food diaries will be used to assess energy intake during each
      condition; these data will be separated into three time segments: wake to 10:30, 10:30 to
      15:30 and 15:30 to bed. Visual analogue scales will be used to assess perceptions of hunger,
      fullness, tiredness and energy levels on waking and at 09:00 and 10:30. Statistical analyses
      will be completed using condition by time of day linear mixed models.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Physical activity energy expenditure (kJ/day)
time frame: Seven days
description: Free-living physical activity energy expenditure from sedentary, light, moderate and vigorous activities (kJ/day) assessed using combined heart rate-accelerometry across seven consecutive days.
measure: Time spent in physical activity (minutes/day)
time frame: Seven days
description: Time spent sedentary and in light, moderate and vigorous physical activity (minutes/day) assessed using combined heart rate-accelerometry across seven consecutive days.
measure: Energy intake (kJ/day)
time frame: Four days
description: Energy intake (kJ/day) assessed using combined digital photography and food diaries across four days.
measure: Carbohydrate intake (g/day)
time frame: Four days
description: Carbohydrate intake (g/day) assessed using combined digital photography and food diaries across four days.
measure: Fat intake (g/day)
time frame: Four days
description: Fat intake (g/day) assessed using combined digital photography and food diaries across four days.
measure: Protein intake (g/day)
time frame: Four days
description: Protein intake (g/day) assessed using combined digital photography and food diaries across four days.
measure: Fibre intake (g/day)
time frame: Four days
description: Fibre intake (g/day) assessed using combined digital photography and food diaries across four days.
measure: Perceived hunger (mm)
time frame: Four days
description: Perceived hunger (mm) assessed using 0-100 mm visual analogue scales on waking, at 09:00 and at 10:30 on four days. Higher values equate to higher hunger.
measure: Perceived fullness (mm)
time frame: Four days
description: Perceived fullness (mm) assessed using 0-100 mm visual analogue scales on waking, at 09:00 and at 10:30 on four days. Higher values equate to higher fullness.
measure: Perceived tiredness levels (mm)
time frame: Four days
description: Perceived tiredness levels (mm) assessed using 0-100 mm visual analogue scales on waking, at 09:00 and at 10:30 on four days. Higher values equate to higher tiredness.
measure: Perceived energy levels (mm)
time frame: Four days
description: Perceived energy levels (mm) assessed using 0-100 mm visual analogue scales on waking, at 09:00 and at 10:30 on four days. Higher values equate to higher energy levels.
arm group label: Breakfast consumption
arm group type: Experimental
description: Participants will be asked to consume a standardised breakfast at home before 09:00 for seven consecutive days. The energy content of the breakfast will be 25% of individual measured resting metabolic rate. Prior to the experimental conditions, the participants will select one wholegrain, high-fibre ready-to-eat cereals (with the option of adding raisins) and fruit juice from a limited selection. Thus, breakfast composition will be controlled within participants, but not between participants to account for individual preferences. To ensure that the correct amount of each breakfast item is consumed, food items will be provided to the participants in pre-packaged containers and the participants will be provided with a marked beaker to measure their milk and juice each morning. The only exception is that parents will be asked to provide the 1.8% milk.
arm group label: Breakfast omission
arm group type: Experimental
description: Participants were asked to abstain from all energy-providing nutrients before 10:30 for seven consecutive days.
intervention type: Other
intervention name: Breakfast consumption
description: Standardised breakfast consumption across seven days
arm group label: Breakfast consumption
intervention type: Other
intervention name: Breakfast omission
description: No breakfast consumed across seven days
arm group label: Breakfast omission
criteria: 
gender: Female
minimum age: 11 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Julia K Fruer, PhD
role: Principal Investigator
affiliation: University of Bedfordshire
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Bedfordshire
investigator full name: Dr Julia Fruer
investigator title: Senior Lecturer in Health, Nutrition and Exercise
mesh term: Insulin Resistance
mesh term: Pediatric Obesity
sharing ipd: No