Breakfast Omission and Energy Balance in Girls

Sponsor
University of Bedfordshire (Other)
Overall Status
Completed
CT.gov ID
NCT04481776
Collaborator
(none)
39
1
2
13.9
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Breakfast consumption
  • Other: Breakfast omission
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jan 15, 2018
Actual Primary Completion Date :
Mar 15, 2019
Actual Study Completion Date :
Mar 15, 2019

Arms and Interventions

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.

Other: Breakfast consumption
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.

Other: Breakfast omission
No breakfast consumed across seven days

Outcome Measures

Primary Outcome Measures

  1. Physical activity energy expenditure (kJ/day) [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) [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 Outcome Measures

  1. Energy intake (kJ/day) [Four days]

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

  2. Carbohydrate intake (g/day) [Four days]

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

  3. Fat intake (g/day) [Four days]

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

  4. Protein intake (g/day) [Four days]

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

  5. Fibre intake (g/day) [Four days]

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

  6. Perceived hunger (mm) [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) [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 14 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Bedfordshire Bedford Bedfordshire United Kingdom MK41 9EA

Sponsors and Collaborators

  • University of Bedfordshire

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Julia Fruer, Senior Lecturer in Health, Nutrition and Exercise, University of Bedfordshire
ClinicalTrials.gov Identifier:
NCT04481776
Other Study ID Numbers:
  • Bedfordshire
First Posted:
Jul 22, 2020
Last Update Posted:
Jul 24, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr Julia Fruer, Senior Lecturer in Health, Nutrition and Exercise, University of Bedfordshire
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 24, 2020