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Breakfast Omission and Energy Balance in Girls

Primary Purpose

Adolescent Obesity, Insulin Resistance, Adolescent Behavior

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Breakfast consumption
Breakfast omission
Sponsored by
University of Bedfordshire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adolescent Obesity focused on measuring Breakfast, Physical activity, Nutrition, Appetite, Sedentary

Eligibility Criteria

11 Years - 14 Years (Child)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Parental informed consent
  • Child assent

Exclusion Criteria:

  • Health related issues identified from a health screen questionnaire that could be adversely affected by participation or could affect the study outcomes (e.g., allergies to the breakfast meals, fitted with a pacemaker)
  • Unable to walk or wear a combined heart rate-accelerometer on the chest.

Sites / Locations

  • University of Bedfordshire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Breakfast consumption

Breakfast omission

Arm 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.

Participants were asked to abstain from all energy-providing nutrients before 10:30 for seven consecutive days.

Outcomes

Primary Outcome Measures

Physical activity energy expenditure (kJ/day)
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.
Time spent in physical activity (minutes/day)
Time spent sedentary and in light, moderate and vigorous physical activity (minutes/day) assessed using combined heart rate-accelerometry across seven consecutive days.

Secondary Outcome Measures

Energy intake (kJ/day)
Energy intake (kJ/day) assessed using combined digital photography and food diaries across four days.
Carbohydrate intake (g/day)
Carbohydrate intake (g/day) assessed using combined digital photography and food diaries across four days.
Fat intake (g/day)
Fat intake (g/day) assessed using combined digital photography and food diaries across four days.
Protein intake (g/day)
Protein intake (g/day) assessed using combined digital photography and food diaries across four days.
Fibre intake (g/day)
Fibre intake (g/day) assessed using combined digital photography and food diaries across four days.
Perceived hunger (mm)
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.
Perceived fullness (mm)
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.
Perceived tiredness levels (mm)
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.
Perceived energy levels (mm)
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.

Full Information

First Posted
July 17, 2020
Last Updated
July 22, 2020
Sponsor
University of Bedfordshire
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1. Study Identification

Unique Protocol Identification Number
NCT04481776
Brief Title
Breakfast Omission and Energy Balance in Girls
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Obesity, Insulin Resistance, Adolescent Behavior
Keywords
Breakfast, Physical activity, Nutrition, Appetite, Sedentary

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Breakfast consumption
Arm Type
Experimental
Arm 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 Title
Breakfast omission
Arm Type
Experimental
Arm Description
Participants were asked to abstain from all energy-providing nutrients before 10:30 for seven consecutive days.
Intervention Type
Other
Intervention Name(s)
Breakfast consumption
Intervention Description
Standardised breakfast consumption across seven days
Intervention Type
Other
Intervention Name(s)
Breakfast omission
Intervention Description
No breakfast consumed across seven days
Primary Outcome Measure Information:
Title
Physical activity energy expenditure (kJ/day)
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.
Time Frame
Seven days
Title
Time spent in physical activity (minutes/day)
Description
Time spent sedentary and in light, moderate and vigorous physical activity (minutes/day) assessed using combined heart rate-accelerometry across seven consecutive days.
Time Frame
Seven days
Secondary Outcome Measure Information:
Title
Energy intake (kJ/day)
Description
Energy intake (kJ/day) assessed using combined digital photography and food diaries across four days.
Time Frame
Four days
Title
Carbohydrate intake (g/day)
Description
Carbohydrate intake (g/day) assessed using combined digital photography and food diaries across four days.
Time Frame
Four days
Title
Fat intake (g/day)
Description
Fat intake (g/day) assessed using combined digital photography and food diaries across four days.
Time Frame
Four days
Title
Protein intake (g/day)
Description
Protein intake (g/day) assessed using combined digital photography and food diaries across four days.
Time Frame
Four days
Title
Fibre intake (g/day)
Description
Fibre intake (g/day) assessed using combined digital photography and food diaries across four days.
Time Frame
Four days
Title
Perceived hunger (mm)
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.
Time Frame
Four days
Title
Perceived fullness (mm)
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.
Time Frame
Four days
Title
Perceived tiredness levels (mm)
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.
Time Frame
Four days
Title
Perceived energy levels (mm)
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.
Time Frame
Four days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Parental informed consent Child assent Exclusion Criteria: Health related issues identified from a health screen questionnaire that could be adversely affected by participation or could affect the study outcomes (e.g., allergies to the breakfast meals, fitted with a pacemaker) Unable to walk or wear a combined heart rate-accelerometer on the chest.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia K Fruer, PhD
Organizational Affiliation
University of Bedfordshire
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bedfordshire
City
Bedford
State/Province
Bedfordshire
ZIP/Postal Code
MK41 9EA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Breakfast Omission and Energy Balance in Girls

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