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Completed

NCT Number: NCT04481776

Breakfast Omission and Energy Balance in Girls

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.

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Key information

Conditions

Adolescent Obesity Adolescent Behavior Behavior Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Sedentary Behavior Signs and Symptoms

Age range

11 year–14 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Bedfordshire

Bedford, Bedfordshire, MK41 9EA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breakfast consumption

Other

Standardised breakfast consumption across seven days

Breakfast Omission

Other

No breakfast consumed across seven days

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Energy intake (kJ/day)

    Time frame: Four days

    Energy intake (kJ/day) assessed using combined digital photography and food diaries across four days.

  2. Carbohydrate intake (g/day)

    Time frame: Four days

    Carbohydrate intake (g/day) assessed using combined digital photography and food diaries across four days.

  3. Fat intake (g/day)

    Time frame: Four days

    Fat intake (g/day) assessed using combined digital photography and food diaries across four days.

  4. Protein intake (g/day)

    Time frame: Four days

    Protein intake (g/day) assessed using combined digital photography and food diaries across four days.

  5. Fibre intake (g/day)

    Time frame: Four days

    Fibre intake (g/day) assessed using combined digital photography and food diaries across four days.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

University of Bedfordshire

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 22, 2020
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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