Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/02/2016
Date assigned
25/02/2016
Last edited
17/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Sedentary behaviour is defined as any waking behaviour that doesn’t require much energy and involves mainly sitting down or reclining. Many people spend a large proportion of their day engaged in sedentary behaviour, such as watching television, working on a computer and driving. Previous research has found that people with a sedentary lifestyle tend to have high blood sugar (glucose) levels which could increase their risks of type 2 diabetes and cardiovascular disease (disease of the heart and blood vessels). Recent evidence suggests that those who break up long periods of sitting by standing or walking may help to reduce the negative effects of sedentary behaviour on blood sugar control. It is not yet known whether it is necessary to break up prolonged sitting with at least light-intensity walking or if simply standing can improve glucose control compared with uninterrupted sitting. The aim of this study is to examine the short-term effects of regularly breaking up prolonged sitting with short bouts of standing or light-intensity walking on blood sugar levels following a meal.

Who can participate?
Healthy adults aged between 45 and 65 who are employed full time in a job which involves prolonged sitting.

What does the study involve?
Participants are randomly assigned to undertake three different study conditions in a random order over five days (Monday, Wednesday and Friday). The study conditions last for five hours, and begin with the participants drinking two meal replacement drinks, which contain a known amount of energy and nutrients. The first condition involves uninterrupted, seated office work; the second condition involves seated office work, interrupted by two minutes of standing every 20 minutes; and the third condition involves seated office work interrupted by two minutes of light-intensity walking every 20 minutes. One hour before the start of the first morning, each participant has a glucose sensor (small, thin and flexible wire) inserted under the skin of their belly by the researcher, which is connected to a glucose recorder, stuck to the skin of the belly by an adhesive patch (continuous glucose monitoring system). The glucose sensor continuously measures the amount of glucose (sugar) in the fluid around the participants' cells (interstitial fluid) and the glucose recorder records this concentration every five minutes. Participants wear the continuous glucose monitoring system (CGMS) for five days (until the end of the third study condition). The amount of time it takes for the glucose to be processed by the body in each case is then calculated for all participants from the data recorded by the CGMS.

What are the possible benefits and risks of participating?
Participants benefit from having access to information about their blood sugar levels, which are measured continuously throughout the study. There is a small risk that participants may experience bleeding, swelling, irritation or infection from having the CGMS attached.

Where is the study run from?
The study is run from the University of Bristol Centre for Exercise, Nutrition and Health Sciences, and takes place in eight workplaces with an office environment at the University of Bristol and surrounding area (UK)

When is the study starting and how long is it expected to run for?
April 2014 to March 2015

Who is funding the study?
1. National Institute for Health Research (UK)
2. Bristol Nutrition Biomedical Research Unit in Nutrition, Diet and Lifestyle (UK)

Who is the main contact?
Miss Laura Brocklebank

Trial website

Contact information

Type

Scientific

Primary contact

Miss Laura Brocklebank

ORCID ID

Contact details

Centre for Exercise
Nutrition and Health Sciences
School for Policy Studies
University of Bristol
12 Woodland Road
Bristol
BS8 1TZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Stand Up For Your Health: The acute effects of breaking up seated office work with standing or light-intensity walking on interstitial glucose concentration

Acronym

SUFYH

Study hypothesis

The aim of this study is to examine the acute effects of regularly breaking up seated office work with short bouts of standing or light-intensity walking on interstitial glucose concentration.

Ethics approval

University of Bristol Faculty of Science Human Research Ethics Committee, 29/04/2014, ref: 4007

Study design

Randomised three-period three-treatment crossover trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Interstitial glucose control

Intervention

Each participant is visited at their workplace on three separate days over a period of a week (Monday, Wednesday and Friday) and perform three five-hour trial conditions in a random order

Uninterrupted sitting (control): participants performed five hours of uninterrupted seated office work, only rising from their chair to use the toilet.

Sitting interrupted by standing: participants rose from their chair every 20 minutes and stood as still as possible at their desk for two minutes.

Sitting interrupted by light-intensity walking: participants rose from their chair every 20 minutes and walked around their workplace at a light intensity (Borg RPE rating of 9) for two minutes.

In each condition, participants are asked to consume two meal replacement drinks (total of 600kcal of energy, 73.6g of carbohydrate and 23.2g of fat) at baseline. One hour prior to commencing the first condition, a glucose sensor is affixed to the abdomen of participants to monitor glucose concentration every five minutes until the end of the condition. Participants wear their waterproof continuous glucose monitoring system (CGMS) for five consecutive days (until the end of trial condition three).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Interstitual glucose concentration is measure using a continuous glucose monitoring system (CGMS) for the duration of the study (five days). The data recorded is used to calculate postprandial and preprandial interstitial glucose incremental area under the curve (iAUC) after each of the five-hour trial conditions.

Secondary outcome measures

N/A

Overall trial start date

01/04/2014

Overall trial end date

06/03/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Between 45 and 65 years of age
2. Employed full-time in an entirely sedentary or semi-sedentary occupation

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

17

Participant exclusion criteria

1. Pregnancy
2. Clinically diagnosed diabetes
3. Non-English speaking
4. Taking lipid-lowering medication
5. Major illness or injury (acute or chronic)

Recruitment start date

19/06/2014

Recruitment end date

16/02/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol Centre for Exercise, Nutrition and Health Sciences
Centre for Exercise, Nutrition and Health Sciences School for Policy Studies University of Bristol 12 Woodland Road
Bristol
BS8 1TZ
United Kingdom

Trial participating centre

Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Trial participating centre

The Hawthorns
14-16 Woodland Road
Bristol
BS8 1UQ
United Kingdom

Trial participating centre

University of Bristol
School for Policy Studies 8 Priory Road
Bristol
BS8 1TZ
United Kingdom

Trial participating centre

University of Bristol
IT Services Computer Centre 5 Tyndall Avenue
Bristol
BS8 1UD
United Kingdom

Trial participating centre

University of Bristol
Wills Memorial Library Queen's Road
Bristol
BS8 1RJ
United Kingdom

Trial participating centre

University of Bristol
Strategic Projects Office 8-10 Berkeley Square
Bristol
BS8 1HH
United Kingdom

Trial participating centre

Queen's Building
University Walk
Bristol
BS8 1TR
United Kingdom

Trial participating centre

University of Bristol
School of Economics Finance and Management 8 Woodland Road
Bristol
BS8 1TN
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Research and Enterprise Development
3rd Floor Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

Bristol Nutrition Biomedical Research Unit in Nutrition, Diet and Lifestyle

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication the results of this study in Diabetes Care.

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

17/03/2016: Verified study information with principal investigator.