NCT04336540

Brief Summary

Two randomized control trials examining human food choice (i.e. selection of high energy 'unhealthy' foods vs. selection of healthier foods). Interventions: In a between-subjects design, participants (recruitment stratified by socioeconomic position) made food choices (main dish, plus optional sides and desserts) in the absence vs. presence of menu energy labelling and from menus with baseline (10%) vs. increased availability (50%) of lower energy main dishes. Main outcome measures: Average energy content (kcal) of main dish chosen and average total energy content of all food ordered, including optional sides and desserts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,091

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

April 2, 2020

Last Update Submit

April 6, 2020

Conditions

Diet, HealthyNutrition PoorObesityFood Selection

Outcome Measures

Primary Outcomes (1)

  • Energy ordered from main menu

    Total kcal content of main menu order

    15-20 minutes (the time frame denotes time taken to make the menu order and there is no follow up

Secondary Outcomes (1)

  • Total energy ordered

    15-20 minutes (the time frame denotes time taken to make the menu order and there is no follow up

Study Arms (4)

Energy labelling

EXPERIMENTAL

Energy labelling provided on restaurant menus

Other: Menu configuration (presence of energy labelling)

No energy labelling

NO INTERVENTION

No energy labelling provided on restaurant menus

Increased availability of lower energy meals

EXPERIMENTAL

Higher proportion of meals are 600kcals or less

Other: Menu configuration (presence of energy labelling)Other: Menu configuration (more lower energy options added)

Baseline availability of lower energy meals

NO INTERVENTION

Proportion of meals that are 600kcals or less at baseline level

Interventions

Menu configuration (presence of energy labelling)OTHER

Restaurant menus are altered to accommodate energy labelling intervention

Energy labellingIncreased availability of lower energy meals
Menu configuration (more lower energy options added)OTHER

Restaurant menus are altered to include more lower energy options

Increased availability of lower energy meals

Eligibility Criteria

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

You may qualify if:

  • Participants were eligible to participate if they were US residents, aged of 18 or above, fluent in English, had access to a computer with an internet connection and had no dietary restrictions

You may not qualify if:

  • See above.
  • Stratification Criteria:
  • \- We aimed to recruit a sample stratified by gender (approx. 50/50) and highest educational qualification (approx. 40% high school or less, 60% above high school) to be broadly representative of US adults.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Liverpool

Liverpool, Merseyside, L69 7ZA, United Kingdom

Location

Related Publications (1)

  • Marty L, Reed SM, Jones AJ, Robinson E. Increasing availability of lower energy meals vs. energy labelling in virtual full-service restaurants: two randomized controlled trials in participants of higher and lower socioeconomic position. BMC Public Health. 2021 May 25;21(1):975. doi: 10.1186/s12889-021-11007-0.

    PMID: 34034699DERIVED

MeSH Terms

Conditions

MalnutritionObesityFood Preferences

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

  • Eric Robinson, PhD

    University of Liverpool

    PRINCIPAL INVESTIGATOR

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 2, 2020

First Posted

April 7, 2020

Study Start

August 1, 2019

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

April 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

Shared on the Open Science Framework

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

Locations

GB(1)