Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/01/2017
Date assigned
12/01/2017
Last edited
14/02/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
People from disadvantaged communities tend to eat fewer fruits and vegetables and more high-calorie foods; they also benefit less from programs that teach people how to actively change their behaviour. Cognitive resources (a set of mental processes involved in planning and regulating thoughts and behaviour) are reduced by years spent living in poverty in childhood. Therefore, an alternative method that does not rely on cognitive resources is needed to improve intake of fruit and vegetables and reduce intake of high-calorie foods in disadvantaged communities. Making changes to the environment, such as placing food further away, is thought to change people’s behaviour unconsciously, as people generally eat more of a food when it is placed within reach. There is a need for higher quality studies of this food distance effect, specifically focusing on whether this effect occurs for healthy and unhealthy food options when they are provided at the same time at different distances. The research team previously conducted two studies which looked only at the placement of an unhealthy food option. This study will improve on the methods of the earlier studies however, by providing participants with two food options, one healthy and unhealthy, which is more similar to a real-world food environment where people actively make choices between options. The aim of this study is to assess whether placing unhealthy food further away discourages consumption of that food when a healthy food option is also available either at the same distance or closer.

Who can participate?
Healthy adults who live in Cambridge and surrounding areas.

What does the study involve?
Participants are randomly allocated into one of four groups. In each group, the participants are provided with two bowls of snack food placed at varying distances either near at 20cm or far at 70cm relative to one another during a 10 minute “relaxation break”. In the first group, the healthy food is placed near and the unhealthy food far, in the second group, the unhealthy food is near and the healthy food far. In the third group both foods are placed near while in the fourth group both foods are placed far from the participant. All participants are asked to memorise a string of digits to induce cognitive load at the beginning of the session, which they will recall at the end. Participants also complete the Stroop task (a task which involves reading the names of colours which are written in a different colour) before memorising number and after the relaxation break to measure cognitive resources. At the end of the session, they complete questionnaires about hunger, liking for the snacks and other measures related to the food.

What are the possible benefits and risks of participating?
There are no direct benefits for participants; however the study will help to provide information about ways of influencing food choice and diet that can be applied to further research. There are no risks of participating in the study.

Where is the study run from?
The Behaviour and Health Research Unit, University of Cambridge (UK)

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

Who is funding the study?
1. Medical Research Council (UK)
2. NIHR Senior Investigator Award (UK)
3. Department of Health Policy Research Programme (UK)

Who is the main contact?
Professor Theresa Marteau

Trial website

Contact information

Type

Scientific

Primary contact

Prof Theresa Marteau

ORCID ID

Contact details

University of Cambridge
Institute of Public Health
Forvie Site
Cambridge
CB2 OSR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of proximity on consumption of healthy and unhealthy food: an experimental study in a general population with low cognitive resource

Acronym

Study hypothesis

1. A higher proportion of participants will take each food when it is proximal compared to when it is distal
2. The proportions of participants taking each food will be equivalent at each given distance for both healthy and unhealthy food
3. A higher proportion of participants will take a near healthier food when an unhealthier food is far compared to when the unhealthier food is at the same distance

Ethics approval

Cambridge Psychology Research Ethics Committee, 19/12/2016, ref: PRE.2016.088

Study design

Between-subjects design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

See additional files

Condition

Unhealthy diet

Intervention

Participants are told they will be taking part in a relaxation and memory study so that the snack foods can be placed without making participants aware that the study is assessing eating behaviour (knowing this may affect whether they eat in the study). Participants are fully debriefed at the end of the session. Participants are randomly allocated to one of four conditions where food is provided during a 10 minute relaxation break.

1. Healthy food proximal, unhealthy food distal
2. Unhealthy food proximal, healthy food distal
3. Both foods proximal
4. Both foods distal

Two food bowls are placed at the same time varying at two different distances from the participant’s position. When a bowl is proximal, it is placed 20cm from the right hand of the participant and when the bowl is distal, it is placed 70cm from the right hand of the participant.

Chocolate M&Ms (without peanuts) are provided as the unhealthy snack option and fruit is provided as the healthy snack option.

All participants are asked to memorise a set of digits before the relaxation break to induce cognitive load, which they will recall at the end of the session. The Stroop task is completed before the relaxation break to record baseline cognitive resource, and after the break to check the cognitive load manipulation.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Proportion of participants taking any of either snack food, measured as any difference in bowl weight from before to after the participant is exposed to the snacks.

Secondary outcome measures

1. Mean amount of each snack food consumed is measured as the difference in bowl weight from before to after the participant is exposed to the snacks
2. Executive function, measured using the Stroop task (Stroop, 1935) before exposure to the snack food
3. Ratings of perceived effort to obtain the snacks and salience of the snacks, collected using a questionnaire following exposure to the snack food
4. The proximity effect is measured by the difference in intake of the snacks at each given distance after the relaxation break. This difference in intake is compared before and after excluding participants who move the bowl.

Overall trial start date

14/10/2016

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults aged over 18 years
2. Cambridgeshire and surrounding areas

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

248

Participant exclusion criteria

Any allergies or intolerance to food relevant to the study.

Recruitment start date

18/01/2017

Recruitment end date

30/03/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Behaviour and Health Research Unit
University of Cambridge Institute of Public Health Forvie Site Robinson Way
Cambridge
CB2 OSR
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

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

NIHR Senior Investigator Award

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Department of Health Policy Research Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of the main study results in a high-impact factor journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

31/01/2017: A fourth secondary outcome measure has been added. 18/01/2017: The recruitment start date has been updated from 16/01/2017 to 18/01/2017. In addition, a third hypothesis and second and third secondary outcome measures have been added.