Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/09/2016
Date assigned
22/09/2016
Last edited
23/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
On average, people consume about a third of our weekday energy (calorie) intake at work and what is eaten and drunk affects both health and productivity. For this reason, many companies are keen to encourage healthy eating in the workplace, for instance through the range of products they offer, the way they present items and other related information they provide. The environment has a marked effect on food and drink choices, much more than most people realise. There is a lot of interest in how so-called ‘nudge’ techniques can be used to change environments and prompt individuals to make healthier choices. However, so far there has been very little research to study the impact of this kind of intervention (program) to improve employees' diets in the workplace. The aim of this study is to explore the feasibility and effectiveness of three different interventions within a workplace environment.

Who can participate?
Eighteen English worksites from companies that are members of the Institute for Grocery Distribution with more than 350 employees.

What does the study involve?
Eighteen workplace sites will participate in these studies and six sites will take part in each intervention. Sites will introduce the intervention that they have been assigned at two week intervals, over a 12 week period, in a carefully planned, but random order, known as a ‘stepped wedge design’.
The first intervention involves introducing smaller portion sizes. This involves pre-packaged items being provided in the next available smaller size (e.g. a 25g packet of crisps instead of a 33g packet of crisps) and served food portions being made smaller (e.g. a cake being divided into 10 slices rather than 8). The second intervention involves changing the availability of different foods to increase the amount of healthy foods being available compared to unhealthy options (e.g. providing baked crisps instead of fried ones). The third intervention involves adding labels to foods which include the energy (calorie) content on the packet or at the edge of the shelf or other prominent position. For the four weeks before the interventions are introduced and then over the course of the interventions, information about the food sold in each of the workplace sites is collected in order to find out if the interventions have changed the way that people buy food.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved for those participating.

Where is the study run from?
The study is run from the Behaviour and Health Research Unit at the University of Cambridge and takes place at 18 English worksites from companies that are members of the Institute for Grocery Distribution (UK)

When is the study starting and how long is it expected to run for?
April 2016 to September 2017

Who is funding the study?
1. Institute of Grocery Distribution (UK)
2. Department of Health Policy Research Program (UK)

Who is the main contact?
Professor Theresa Marteau

Trial website

Contact information

Type

Scientific

Primary contact

Prof Theresa Marteau

ORCID ID

http://orcid.org/0000-0003-3025-1129

Contact details

University of Cambridge
Institute of Public Health
Forvie Site
Cambridge
CB2 0SR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Physical micro-environment interventions for healthier eating in the workplace: A pilot study

Acronym

Study hypothesis

The aim of this study is to evaluate the impact on energy purchased of:
1. Reducing the sizing of packages and/or portions of higher energy foods or drinks and/or tableware size
2. Reducing higher energy foods and drinks available in cafeterias and replacing these with the equivalent number of lower energy food and drinks
3. Adding labels showing energy (calorie) content on items purchased from cafeterias

Ethics approval

Cambridge Psychology Research Ethics Committee, 29/04/2016, ref: PRE.2016.035

Study design

Randomised stepped wedge study

Primary study design

Interventional

Secondary study design

Stepped Wedge Design

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

Excess energy intake

Intervention

The 18 worksites (with a minimum of 350 employees) will be allocated to one of these three sets depending on their readiness to start, determined by data collection systems in place. The first six sites to be ready will be allocated to the first intervention ready for implementation: labelling. The remaining 12 sites will be randomly allocated to implement either the sizing or the availability interventions. Within each of the three sets of six sites, the time at which the intervention is introduced will be determined by randomisation to control for time trends while maximising sample size. Sites will be randomised to a phase of the stepped wedge design by means of random permutations using random variates of the uniform distribution. There will be a four week pre-intervention period when normal service will continue while information is collected on the energy content of food available and on the sales each day. The sites will then undergo an intervention period lasting from two - twelve weeks (depending on randomisation sequence within the stepped-wedge design).

The precise nature of the interventions will vary between sites, depending upon the food, drink and tableware currently on sale. For example, if sugar sweetened beverages are already those at the smallest available size (e.g., a 150ml can or carton of drink) these will not be a focus for reduction in size. The target products for each intervention will be documented and included as covariates in the analyses.

For all three sets of interventions foods where the energy content can be reduced will be targeted, whether by reductions in portion size, reformulation (primarily reductions in fat or sugar) or by offering a substitute product (e.g., non-nutritively sweetened beverages to replace sugar sweetened beverages, or baked products to replace deep-fried savoury snacks). Products containing little or no energy (<5 kcal/100g) will be specifically excluded from the interventions, such as non-nutritively sweetened beverages or chewing gum, and all fresh fruit and vegetables with no added fat or sugar.

Intervention 1 - Size:
The intervention will comprise three components:
1. Packaged products: Replace currently available higher energy packaged food and drinks in cafeterias with the next, smaller available package size.
2. Portion sizes of served foods: Reduce the size of portions of higher energy food and drink items served in cafeterias by approximately 10% to 15%, including main meal (e.g., lasagne); sides (e.g., chips or fries); and desserts, cakes, cookies and biscuits, relative to the current standard size.
This might involve cutting 10 portions of lasagne from a tray that was previously cut into 8 portions, or 10 slices of cake from a cake that was previously cut into 8 slices.
3. Tableware: The size of available glasses, plates, bowls and/or serving cutlery used to serve higher energy food and drink items will be reduced to the next smaller available size.
For all sites, the standard retail price of the packages and portions will be used. In the case of reducing portion size of items which are not pre-packaged (such as cakes or main meals), prices will be reduced proportionally.

Intervention 2 - Availability:
This intervention will involve keeping constant the number of options offered but shifting the ratio of healthier to less healthy options by reducing the higher energy foods and drinks (products or units of the same product) available and increasing the lower energy foods and drinks available.
The size of the change will depend upon the baseline ratio of healthier to less healthy products. For example, in cafeterias where 75% of available options are classified as higher energy the intervention would likely involve having 50% of options as higher.

Intervention 3 - Labelling:
This intervention comprises labels that state the name of a food or drink item together with the calorie content written as ‘XXX Calories’. The latter is to be written in the same font type and size as the product name, legible and prominent to the customer, rounded to the nearest 5 or 10 calories, and clearly denoting the portion size to which it refers. In-keeping with EU regulations kilocalorie (kcal) and kilojoule (kj) content will be displayed beneath the ‘XXX Calories’.

Continued measures of the energy content of food available and the sales data throughout the intervention period will be used to model any changes from baseline levels. The number of transactions that involve products that have been altered as a result of our interventions will also be measured. Follow-up after the intervention period ends is not planned.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Total energy (calories) purchased per time frame of analysis (daily or weekly) controlling for the total sales/transactions is measured from daily sales records.

Secondary outcome measures

Total energy (calories) purchased per time frame of analysis (daily or weekly) from intervention items and non-intervention items controlling for the total sales/transactions is measured from daily sales records.

Overall trial start date

04/04/2016

Overall trial end date

30/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. English worksites from companies that are members of the Institute for Grocery Distribution (IGD)
2. More than 350 employees
3. Mix of office-based and other site types (to recruit sites that are likely to represent different ranges of socio-economic status)
4. Ability to provide weekly data on sales of individual items and their energy content

Participant type

Other

Age group

Other

Gender

Both

Target number of participants

The target number of sites is 18 (minimum 350 employees in each) to allow 6 sites within each intervention

Participant exclusion criteria

Sites not meeting the inclusion criteria.

Recruitment start date

08/08/2016

Recruitment end date

01/05/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Behaviour and Health Research Unit
University of Cambridge Institute of Public Health Forvie Site
Cambridge
CB2 0SR
United Kingdom

Sponsor information

Organisation

University of Cambridge

Sponsor details

Trinity Lane
Cambridge
CB2 1TN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Institute of Grocery Distribution (IGD)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Department of Health Policy Research Program

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Planned submission of the main results of this study for publication in a high-impact factor journal
2. Planned dissemination of the results to the public, policy makers and other researchers through targeted social media

IPD Sharing plan:
The data are commercially sensitive, provided by the worksites on condition that they are not shared beyond the research team.

Intention to publish date

30/09/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes