NCT04481776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

1.2 years

First QC Date

July 17, 2020

Last Update Submit

July 22, 2020

Conditions

Adolescent ObesityInsulin ResistanceAdolescent Behavior

Keywords

BreakfastPhysical activityNutritionAppetiteSedentary

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (9)

  • Energy intake (kJ/day)

    Four days

  • Carbohydrate intake (g/day)

    Four days

  • Fat intake (g/day)

    Four days

  • Protein intake (g/day)

    Four days

  • Fibre intake (g/day)

    Four days

  • +4 more secondary outcomes

Study Arms (2)

Breakfast consumption

EXPERIMENTAL

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

Breakfast omission

EXPERIMENTAL

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

Other: Breakfast omission

Interventions

Breakfast consumptionOTHER

Standardised breakfast consumption across seven days

Breakfast consumption
Breakfast omissionOTHER

No breakfast consumed across seven days

Breakfast omission

Eligibility Criteria

Age11 Years - 14 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parental informed consent
  • Child assent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bedfordshire

Bedford, Bedfordshire, MK41 9EA, United Kingdom

Location

MeSH Terms

Conditions

Pediatric ObesityInsulin ResistanceAdolescent BehaviorMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBehavior

Study Officials

  • Julia K Fruer, PhD

    University of Bedfordshire

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Health, Nutrition and Exercise

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 22, 2020

Study Start

January 15, 2018

Primary Completion

March 15, 2019

Study Completion

March 15, 2019

Last Updated

July 24, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)