- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04481776
Breakfast Omission and Energy Balance in Girls
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 Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bedfordshire
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Bedford, Bedfordshire, United Kingdom, MK41 9EA
- University of Bedfordshire
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Standardised breakfast consumption across seven days
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Experimental: Breakfast omission
Participants were asked to abstain from all energy-providing nutrients before 10:30 for seven consecutive days.
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No breakfast consumed across seven days
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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.
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Seven days
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Time spent in physical activity (minutes/day)
Time Frame: Seven days
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Time spent sedentary and in light, moderate and vigorous physical activity (minutes/day) assessed using combined heart rate-accelerometry across seven consecutive days.
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Seven days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy intake (kJ/day)
Time Frame: Four days
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Energy intake (kJ/day) assessed using combined digital photography and food diaries across four days.
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Four days
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Carbohydrate intake (g/day)
Time Frame: Four days
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Carbohydrate intake (g/day) assessed using combined digital photography and food diaries across four days.
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Four days
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Fat intake (g/day)
Time Frame: Four days
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Fat intake (g/day) assessed using combined digital photography and food diaries across four days.
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Four days
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Protein intake (g/day)
Time Frame: Four days
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Protein intake (g/day) assessed using combined digital photography and food diaries across four days.
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Four days
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Fibre intake (g/day)
Time Frame: Four days
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Fibre intake (g/day) assessed using combined digital photography and food diaries across four days.
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Four days
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Perceived hunger (mm)
Time Frame: Four days
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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.
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Four days
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Perceived fullness (mm)
Time Frame: Four days
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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.
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Four days
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Perceived tiredness levels (mm)
Time Frame: Four days
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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.
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Four days
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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.
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Four days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julia K Fruer, PhD, University of Bedfordshire
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bedfordshire
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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