Effect of kcal and PACE Labelling on Self-served Portion Size

• Sponsor: University of Liverpool (Other)
• Overall Status: Completed
• CT.gov ID: NCT04340804
• Collaborator: (none)
• Enrollment: 1,800
• Location: 1
• Arms: 4
• Actual Duration (Days): 30
• Patients Per Site Per Month: 1826.3

Study Details

Study Description

Brief Summary

Participants will take part in an online survey. They will be asked to choose the amount of food they would like to eat based on pictures of 18 dishes sequentially displayed on the screen. They will be randomly allocated to four different groups: kcal labelling, PACE labelling (Physical Activity Calorie Equivalent: minutes to walk to burn off the calories), kcal and PACE labelling combined, no labelling, in a between subject design. The main outcome variable is the total "self-served" energy for each dish (in kcal).

Condition or Disease	Intervention/Treatment	Phase
Diet, Healthy; Food Selection	Behavioral: Kcal labelling; Behavioral: PACE labelling	N/A

Detailed Description

See attached protocol documents.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Socioeconomic Position and the Effect of kcal Labelling and PACE Labelling on Self-served Portion Size
• Actual Study Start Date: Apr 13, 2020
• Actual Primary Completion Date: Apr 13, 2020
• Actual Study Completion Date: May 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kcal labelling Participants allocated to this group will see on the screen the amount of food increasing or decreasing based on how many times they tap on the corresponding keys and a real-time kcal counter synchronised with the food amount changes (i.e., increasing/decreasing).	Behavioral: Kcal labelling; Real-time kcal counter synchronised with the food amount changes
Experimental: PACE labelling Participants allocated to this group will see on the screen the amount of food increasing or decreasing based on how many times they tap on the corresponding keys and a real-time PACE counter (as minutes needed to walk to burn off the calories) synchronised to the food amount changes (i.e., increasing/decreasing) with 4 min being equivalent to 20 kcal.	Behavioral: PACE labelling; Real-time PACE counter (as minutes needed to walk to burn off the calories) synchronised to the food amount changes
Experimental: Kcal and PACE labelling Participants allocated to this group will see on the screen the amount of food increasing or decreasing based on how many times they tap on the corresponding keys and a real-time kcal and PACE counters synchronised to the food amount changes (i.e., increasing/decreasing).	Behavioral: Kcal labelling; Real-time kcal counter synchronised with the food amount changes; Behavioral: PACE labelling; Real-time PACE counter (as minutes needed to walk to burn off the calories) synchronised to the food amount changes
No Intervention: No labelling Participants allocated to this group will only see on the screen the amount of food increasing or decreasing based how many times they tap on the corresponding keys.

Outcome Measures

Primary Outcome Measures

1. Total self-served energy (kcal) [10 minutes (the time frame denotes time taken to perform the portion selection task and there is no follow up)]

   Energy content of the portion selected for each dish.

Secondary Outcome Measures

1. Kcal influence [3 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)]

   Whether kcal content influences the quantity of self-served food

2. PACE influence [3 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)]

   Whether physical activity energy equivalent influences the quantity of self-served food.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• United Kingdom residents

• Age ≥ 18

• Fluent in English

• Have access to a computer and Internet

Exclusion Criteria:

• Have any dietary restriction (vegetarian, vegan, gluten-free, sugar-free, diary or lactose free, food allergy)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Liverpool	Liverpool	Merseyside	United Kingdom	L69 7ZA

Sponsors and Collaborators

• University of Liverpool

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Apr 7, 2020

More Information

Publications

None provided.

• Responsible Party: Eric Robinson, Principal Investigator, University of Liverpool
• ClinicalTrials.gov Identifier: NCT04340804
• Other Study ID Numbers: 803194 1B4
• First Posted: Apr 10, 2020
• Last Update Posted: Nov 3, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eric Robinson, Principal Investigator, University of Liverpool: kcal labelling; PACE labelling; portion size; socio-economic position

Study Results

No Results Posted as of Nov 3, 2020