NCT04340791

Brief Summary

This study will be a 2x2 randomised controlled trial with information-based intervention (no labelling / labelling) and structural intervention (default proportion / increased proportion of lower energy density food items) as between-subject factors and energy density (kcal/g) of food purchases during an online supermarket-shopping task as dependent variable. This study will use an online supermarket platform developed to mimic an online supermarket website and participants will be asked to complete a shopping task using a pre-determined shopping list of 10 items.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

April 13, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

Same day

First QC Date

April 7, 2020

Last Update Submit

November 2, 2020

Conditions

Keywords

availabilitylabellingfood choicesocio-economic position

Outcome Measures

Primary Outcomes (1)

  • Mean ED of the food items purchased (kcal/100g)

    Calculated as the sum of the energy of the purchased items (kcal) divided by the sum of their weight (g) and multiplied by 100.

    20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)

Secondary Outcomes (6)

  • Total energy of the food items purchased (kcal)

    20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)

  • Energy from total sugar (% of total energy)

    20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)

  • Energy from saturated fatty acids (SFA) (% of total energy)

    20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)

  • Salt content (g/100g)

    20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)

  • Proportion of lower energy density food items in the basket of foods purchased

    20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)

  • +1 more secondary outcomes

Other Outcomes (2)

  • Validity

    5 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)

  • Kcal influence

    5 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)

Study Arms (4)

Default proportion & no labelling

NO INTERVENTION

No intervention: Default proportion condition (33% lower energy density items - 67% higher energy density items). Lower energy density items will be defined as lower ED ≤ median of ED distribution within a food category. No labelling.

Default proportion & labelling

EXPERIMENTAL

When energy density of a food item ≤ median of energy density distribution within a food category, "healthier choice" badges will be added to the food item pictures on the online supermarket. Instructions will introduce the badges to the participants as "In the online supermarket, the green tick allows you to see which products (e.g. muesli) in each product category (e.g. cereals) are healthier choices with fewer calories per gram than most other products in the same category."

Behavioral: Labelling

Increased proportion & no labelling

EXPERIMENTAL

The proportion of lower energy density items vs. higher energy density items will be reversed (67% lower - 33% higher) relative to the default proportion condition (33% lower - 67% higher). Lower energy density items will be defined as lower ED ≤ median of ED distribution within a food category.

Behavioral: Increased proportion of lower energy density items

Increased proportion & labelling

EXPERIMENTAL

The proportion of lower energy density items vs. higher energy density items will be reversed (67% lower - 33% higher) relative to the default proportion condition (33% lower - 67% higher). Lower energy density items will be defined as lower ED ≤ median of ED distribution within a food category. When energy density of a food item ≤ median of energy density distribution within a food category, "healthier choice" badges will be added to the food item pictures on the online supermarket. Instructions will introduce the badges to the participants as "In the online supermarket, the green tick allows you to see which products (e.g. muesli) in each product category (e.g. cereals) are healthier choices with fewer calories per gram than most other products in the same category."

Behavioral: Increased proportion of lower energy density itemsBehavioral: Labelling

Interventions

The proportion of lower energy density vs. higher energy density items will be reversed (67% lower - 33% higher) relative to the default proportion condition (D and DL) (33% lower - 67% higher). Lower energy density items will be defined as lower energy density ≤ median of energy density distribution within a food category.

Increased proportion & labellingIncreased proportion & no labelling
LabellingBEHAVIORAL

When energy density of an item ≤ median of ED distribution within a food category, "healthier choice" badges will be added to the food item pictures on the online supermarket. Instructions when logging-into the platform will introduce the badges to the participants: "In the online supermarket, the green tick allows you to see which products (e.g. muesli) in each product category (e.g. cereals) are healthier choices with fewer calories per gram than most other products in the same category."

Default proportion & labellingIncreased proportion & labelling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • United Kingdom residents
  • Aged ≥ 18 years
  • Fluent in English
  • Have access to a computer and Internet
  • Responsible for a substantial proportion of household grocery shopping

You may not qualify if:

  • Unable to provide informed consent and to comply with the study requirements
  • Any dietary restriction (vegetarian, vegan, gluten-free, sugar-free, dairy or lactose free, food allergy, other)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Liverpool

Liverpool, Merseyside, L69 7ZA, United Kingdom

Location

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 10, 2020

Study Start

April 13, 2020

Primary Completion

April 13, 2020

Study Completion

May 13, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Shared on the Open Science Framework

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
On publication, indefinitely
Access Criteria
Open website
More information

Available IPD Datasets

Study Protocol Access
Statistical Analysis Plan Access
Informed Consent Form Access
Individual Participant Data Set Access

Locations