Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/05/2017
Date assigned
23/05/2017
Last edited
23/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many children and adolescents often skip breakfast and do not engage in the recommended amounts of physical activity. Research has shown that breakfast consumption frequency (i.e., days per week that breakfast is consumed) is linked with increased physical activity in young people. However, these results have not been consistent when using an accelerometer (activity monitor) to measure physical activity. It is also not known whether increased breakfast consumption frequency causes an increase in physical activity, or whether the link is simply because those who eat breakfast generally engage in a range of healthy lifestyle habits. Although some studies in adults have indicated that breakfast consumption can increase physical activity, others have reported no effect, and no study has examined the effects of breakfast consumption frequency on physical activity in children or adolescents. This is particularly important for adolescent girls, who frequently skip breakfast and have low physical activity levels. Therefore, the aim of this study is to examine the effect of daily compared with intermittent breakfast consumption on physical activity in adolescent girls.

Who can participate?
Healthy girls aged 11 to 13

What does the study involve?
The study consists of two periods that last 7 days each: daily breakfast consumption and intermittent breakfast consumption. Daily breakfast consumption involves eating a standard breakfast every day for 7 days. Intermittent breakfast consumption involves eating breakfast on three intermittent days (i.e., days 2, 4 and 6) with four days without breakfast (i.e., days 1, 3, 5 and 7). There is a 7-10 day break in between the two periods. The girls are fitted with a chest-worn combined heart-rate accelerometer device to measure their physical activity throughout each 7-day period.

What are the possible benefits and risks of participating?
The benefits of participating include education on health-related scientific research and use of research equipment. In addition, the participants receive a certificate stating that they have completed the study and receive their individual results in an anonymous format. The research also has indirect benefits for the participants, as the findings will help to inform interventions to increase physical activity in adolescent girls. In the long term, this could help with the prevention of obesity and diseases such as type 2 diabetes and heart disease. Possible risks included feeling light-headed during the exercise tests, but the cool down helps to reduce this and it rarely lasts more than a few minutes. There is also a risk of skin irritation caused by wearing the activity monitor. Therefore, all participants are shown how to remove and fit the monitor and wash the skin appropriately. Those who are allergic to any of the ingredients in the breakfast meals or had certain health conditions (e.g. diabetes, epilepsy) are not able to participate for their own safety.

Where is the study run from?
1. University of Bedfordshire (UK)
2. Loughborough University (UK)

When is study starting and how long is it expected to run for?
July 2014 to December 2016

Who is funding the study?
1. British Academy (UK)
2. Leverhulme Trust (UK)
2. University of Bedfordshire (UK)
3. Loughborough University (UK)

Who is the main contact?
Dr Julia Zakrzewski-Fruer
Julia.Fruer@beds.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Julia Zakrzewski-Fruer

ORCID ID

http://orcid.org/0000-0003-4167-4100

Contact details

University of Bedfordshire
Bedford
MK41 9EA
United Kingdom
+44 (0)123 479 3410
Julia.Fruer@beds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SG142106

Study information

Scientific title

Comparison of daily and intermittent breakfast consumption on physical activity energy expenditure in girls

Acronym

Study hypothesis

Seven days of daily breakfast consumption will result in higher physical activity energy expenditure when compared with intermittent breakfast consumption.

Ethics approval

1. University of Bedfordshire Institute for Sport and Physical Activity Research Ethics Panel, 22/09/2015, ref: 2015ISPAR013
2. Loughborough University Ethics Approvals (Human Participants) Sub-Committee, 30/03/2016, ref: R16-PO39

Study design

Interventional within-participants cross-over study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Physical inactivity

Intervention

The participants completed two, 7-day conditions. The order of the conditions for each participant was produced using a computer-based random number generator by the principal investigator ensuring that the order across the total sample was counterbalanced. The conditions were not masked to the participant.

1. Daily breakfast consumption (DBC): the consumption of a standardized 400 kcal breakfast before 0900 h for 7 consecutive days
2. Intermittent breakfast consumption (IBC): the abstinence from all energy-providing nutrients until at least 1030 h on days 1, 3, 5 and 7 and the consumption of the 400 kcal standardized breakfast on days 2, 4 and 6

All breakfasts were weighed, pre-packaged and provided to the participants prior to each condition. The participants were instructed to consume the breakfasts provided at home. Participants completed both of the conditions and there was a 7-10 day washout between the conditions.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Physical activity energy expenditure from sedentary activities (<1.5 metabolic equivalent (METs)) during wake time to <1030 h (kJ/day)
2. Physical activity energy expenditure from sedentary activities (<1.5 METs) during 1030 h to <1530 h (kJ/day)
3. Physical activity energy expenditure from sedentary activities (<1.5 METs) during 1530 to bed time (kJ/day)
4. Physical activity energy expenditure from light activities (1.5-2.9 METs) during wake time to <1030 h (kJ/day)
5. Physical activity energy expenditure from light activities (1.5-2.9 METs) during 1030 h to <1530 h (kJ/day)
6. Physical activity energy expenditure from light activities (1.5-2.9 METs) during 1530 to bed time (kJ/day)
7. Physical activity energy expenditure from moderate activities (3.0-5.9 METs) during wake time to <1030 h (kJ/day)
8. Physical activity energy expenditure from moderate activities (3.0-5.9 METs) during 1030 h to <1530 h (kJ/day)
9. Physical activity energy expenditure from moderate activities (3.0-5.9 METs) during 1530 to bed time (kJ/day)
10. Physical activity energy expenditure from vigorous activities (>5.9 METs) during wake time to <1030 h (kJ/day)
11. Physical activity energy expenditure from vigorous activities (>5.9 METs) during 1030 h to <1530 h (kJ/day)
12. Physical activity energy expenditure from vigorous activities (>5.9 METs) during 1530 to bed time (kJ/day)
All primary outcomes are measured using combined heart rate/accelerometry continuously throughout each 7-day condition.

Secondary outcome measures

1. Time spent in sedentary activities (<1.5 metabolic equivalent (METs)) during wake time to <1030 h (min/day)
2. Time spent in sedentary activities (<1.5 METs) during 1030 h to <1530 h (min/day)
3. Time spent in sedentary activities (<1.5 METs) during 1530 to bed time (min/day)
4. Time spent in light activities (1.5-2.9 METs) during wake time to <1030 h (min/day)
5. Time spent in light activities (1.5-2.9 METs) during 1030 h to <1530 h (min/day)
6. Time spent in light activities (1.5-2.9 METs) during 1530 to bed time (min/day)
7. Time spent in moderate activities (3.0-5.9 METs) during wake time to <1030 h (min/day)
8. Time spent in moderate activities (3.0-5.9 METs) during 1030 h to <1530 h (min/day)
9. Time spent in moderate activities (3.0-5.9 METs) during 1530 to bed time (min/day)
10. Time spent in vigorous activities (>5.9 METs) during wake time to <1030 h (min/day)
11. Time spent in vigorous activities (>5.9 METs) during 1030 h to <1530 h (min/day)
12. Time spent in vigorous activities (>5.9 METs) during 1530 to bed time (min/day)
All secondary outcomes are measured using combined heart rate/accelerometry continuously throughout each 7-day condition.

Overall trial start date

01/07/2014

Overall trial end date

16/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 11 to 13 years old
2. Female

Participant type

Healthy volunteer

Age group

Child

Gender

Female

Target number of participants

40

Participant exclusion criteria

1. Allergies to the breakfast meals
2. Fitted with a pacemaker
3. Unable to walk
4. Unable to wear a chest-worn combined heart rate/accelerometer
5. Health related issues that could be affected by participation in the study (e.g., uncontrolled exercise-induced asthma, diabetes, epilepsy)

Recruitment start date

01/10/2015

Recruitment end date

12/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bedfordshire
Polhill Avenue
Bedford
MK41 9EA
United Kingdom

Trial participating centre

Loughborough University
Epinal Way
Loughborough
LE11 3TU
United Kingdom

Sponsor information

Organisation

University of Bedfordshire

Sponsor details

Polhill Avenue
Bedford
MK41 9EA
United Kingdom
+44 (0)123 479 3410
Julia.Fruer@beds.ac.uk

Sponsor type

University/education

Website

Organisation

Loughborough University

Sponsor details

Epinal Way
Loughborough
LE11 3TU
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

British Academy

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

University of Bedfordshire

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

Loughborough University

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

Leverhulme Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The research will be published as an original peer-review article in an international journal. Communications at international and national scientific conferences and at internal institutional seminars will provide valuable pathways to further disseminate the findings to academic and non-academic audiences. Additionally, it is expected that the findings will be of direct interest to various stakeholders and organisations, including practitioners implementing healthy-lifestyle programmes, food manufacturers in marketing healthy breakfast meals, schools implementing healthy lifestyle initiatives and school and community breakfast clubs. Therefore, there is great potential to disseminate the findings to the wider community via lay summaries, presentations, the general media and social media.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Julia Zakrzewski-Fruer (Julia.Fruer@beds.ac.uk).

Intention to publish date

01/09/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes