Breakfast Omission and Energy Balance in Girls

July 22, 2020 updated by: Dr Julia Fruer, University of Bedfordshire

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bedfordshire
      • Bedford, Bedfordshire, United Kingdom, MK41 9EA
        • University of Bedfordshire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breakfast consumption
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.
Standardised breakfast consumption across seven days
Experimental: Breakfast omission
Participants were asked to abstain from all energy-providing nutrients before 10:30 for seven consecutive days.
No breakfast consumed across seven days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Julia K Fruer, PhD, University of Bedfordshire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2018

Primary Completion (Actual)

March 15, 2019

Study Completion (Actual)

March 15, 2019

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Actual)

July 24, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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