Breakfast Omission and Energy Balance in Girls

Insulin Resistance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04481776
• Other study ID #: Bedfordshire
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: July 2020
• Source: University of Bedfordshire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Behavior
• Adolescent Obesity
• Insulin Resistance
• Pediatric Obesity

Intervention

Other:
• Breakfast consumption
Standardised breakfast consumption across seven days
• Breakfast omission
No breakfast consumed across seven days

Locations

Country	Name	City	State
United Kingdom	University of Bedfordshire	Bedford	Bedfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Bedfordshire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Seven days
Primary	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.	Seven days
Secondary	Energy intake (kJ/day)	Energy intake (kJ/day) assessed using combined digital photography and food diaries across four days.	Four days
Secondary	Carbohydrate intake (g/day)	Carbohydrate intake (g/day) assessed using combined digital photography and food diaries across four days.	Four days
Secondary	Fat intake (g/day)	Fat intake (g/day) assessed using combined digital photography and food diaries across four days.	Four days
Secondary	Protein intake (g/day)	Protein intake (g/day) assessed using combined digital photography and food diaries across four days.	Four days
Secondary	Fibre intake (g/day)	Fibre intake (g/day) assessed using combined digital photography and food diaries across four days.	Four days
Secondary	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.	Four days
Secondary	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.	Four days
Secondary	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.	Four days
Secondary	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.	Four days