Breakfast Omission and Energy Balance in Girls

NCT ID: NCT04481776

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2019-03-15

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.

Conditions

Adolescent Obesity; Insulin Resistance; Adolescent Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Breakfast consumption

Intervention Type: OTHER

Standardised breakfast consumption across seven days

Breakfast omission

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

Group Type: EXPERIMENTAL

Breakfast omission

Intervention Type: OTHER

No breakfast consumed across seven days

Interventions

Breakfast consumption

Standardised breakfast consumption across seven days

Intervention Type: OTHER

Breakfast omission

No breakfast consumed across seven days

Intervention Type: OTHER

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bedfordshire

OTHER

Sponsor Role: lead

Responsible Party

Dr Julia Fruer

Senior Lecturer in Health, Nutrition and Exercise

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julia K Fruer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bedfordshire

Locations

University of Bedfordshire

Bedford, Bedfordshire, United Kingdom

Countries

United Kingdom

Other Identifiers

Bedfordshire

Identifier Type: -

Identifier Source: org_study_id