NCT05098223

Brief Summary

Study Design: Randomised controlled trial Study Participants: Healthy volunteers from the UK Planned Sample Size: 500 Planned Study Period: June - December 2021 Objectives and Outcome Measures:

  • Objective: To investigate the effect of promotions on the total number of calories selected
  • Measure: Difference in the absolute energy (kcal) of the final basket between the two groups
  • Secondary
  • To investigate the effect of promotions on the nutritional content of the items selected overall, and across the individual target food categories
  • To explore the impact of removing promotions by socioeconomic status Measures:
  • Difference in the absolute sugar (g, kcal, %E), salt (g), and saturated fat (g, kcal, %E) of the final basket between the two groups
  • Difference in the absolute energy (kcal), sugar (g, kcal, %E), salt (g), and saturated fat (g, kcal, %E) between the two groups across the individual target food categories
  • Analyses of the primary and secondary outcomes specified above by gender, age group, ethnic group (White vs Non-White), BMI stratified into \<30 and ≥30kg/m2 groups, education level (lower vs. higher), and household income (lower vs. higher)
  • Exploratory outcomes:
  • Objective: To investigate the acceptability of the intervention
  • Measures: Rating scores and open-ended answers from the follow-up questionnaire

Trial Health

87
On Track

Trial Health Score

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

Enrollment
512

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

October 29, 2021

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2021

Completed
Last Updated

February 17, 2022

Status Verified

September 1, 2021

Enrollment Period

11 days

First QC Date

September 27, 2021

Last Update Submit

February 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • To investigate the effect of promotions on the total number of calories selected

    Difference in the absolute energy (kcal) of the final basket between the two groups

    1 day (immediately after the shopping task)

Secondary Outcomes (8)

  • To investigate the effect of promotions on the nutritional content of the items selected overall, and across the individual target food categories

    1 day (immediately after the shopping task)

  • To investigate the effect of promotions on the nutritional content of the items selected overall, and across the individual target food categories

    1 day (immediately after the shopping task)

  • To investigate the effect of promotions on the nutritional content of the items selected overall, and across the individual target food categories

    1 day (immediately after the shopping task)

  • To investigate the effect of promotions on the nutritional content of the items selected overall, and across the individual target food categories

    1 day (immediately after the shopping task)

  • To investigate the effect of promotions on the nutritional content of the items selected overall, and across the individual target food categories

    1 day (immediately after the shopping task)

  • +3 more secondary outcomes

Other Outcomes (1)

  • To investigate the acceptability of the intervention

    1 day (immediately after the shopping task)

Study Arms (2)

Promotions

NO INTERVENTION

Participants in this group will see a version of the website which will reproduce the types and frequency of promotions that can be found in any online supermarket, for example multi-buy offers and temporary price reductions will be applied to a pre-determined percentage of food products within the target categories \[confectionery; biscuits and crackers; crisps, nuts and snacking fruit; cakes and tarts\]. Promotions will be applied to match the current levels and types of promotions on the website of the largest UK retailer present in a specific week, shortly before the study launch.

No promotions

EXPERIMENTAL

All price promotions will be removed so no promotions will be present on any of the products within the target food categories \[confectionery; biscuits and crackers; crisps, nuts and snacking fruit; cakes and tarts\] offered to participants when searching for products.

Behavioral: Intervention to remove price promotions on unhealthy foods when online shopping

Interventions

Removal of price promotions on unhealthy foods

No promotions

Eligibility Criteria

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

You may qualify if:

  • UK adults, aged ≥18 years.
  • Able to speak and read English.
  • Willing and able to give informed consent for participation in the study.
  • Having access to a computer and Internet.

You may not qualify if:

  • They are following a dairy-free or sugar-free diet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuffield Dept of Primary Care Health Sciences

Oxford, Oxfordshire, OX2 6GG, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigators will be blinded to intervention allocation and will not be able to manipulate any study parameter following the initial study set up, as all study procedures are taking part in the online platform. The outcome assessment is blinded, as it happens automatically in the online platform. The statistician who will analyse the data will be blinded to intervention allocation. Participants will only be aware of the trial arm that they are exposed to and will be unaware of the other trial arm
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a randomised controlled trial with a parallel design. We will use an experimental online shopping platform to mimic the experience of online grocery shopping. Each participant will be randomised 1:1 to one of two groups and will participate in an online shopping task for about 10 minutes during which they will be exposed to a selection of products including promotions or with no promotions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2021

First Posted

October 28, 2021

Study Start

October 29, 2021

Primary Completion

November 9, 2021

Study Completion

November 9, 2021

Last Updated

February 17, 2022

Record last verified: 2021-09

Locations