- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04336540
Increasing Availability of Lower Energy Meals vs. Menu Energy Labelling on Food Choice
April 6, 2020 updated by: Eric Robinson, University of Liverpool
Socioeconomic Position and the Impact of Increasing Availability of Lower Energy Meals vs. Menu Energy Labelling on Food Choice in Virtual Full-service Restaurants: Two Randomized Control Trials
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.
Study Overview
Status
Completed
Conditions
Detailed Description
See attached protocol documents.
Study Type
Interventional
Enrollment (Actual)
2091
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merseyside
-
Liverpool, Merseyside, United Kingdom, L69 7ZA
- University of Liverpool
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Energy labelling
Energy labelling provided on restaurant menus
|
Restaurant menus are altered to accommodate energy labelling intervention
|
|
NO_INTERVENTION: No energy labelling
No energy labelling provided on restaurant menus
|
|
|
EXPERIMENTAL: Increased availability of lower energy meals
Higher proportion of meals are 600kcals or less
|
Restaurant menus are altered to accommodate energy labelling intervention
Restaurant menus are altered to include more lower energy options
|
|
NO_INTERVENTION: Baseline availability of lower energy meals
Proportion of meals that are 600kcals or less at baseline level
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy ordered from main menu
Time Frame: 15-20 minutes (the time frame denotes time taken to make the menu order and there is no follow up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total energy ordered
Time Frame: 15-20 minutes (the time frame denotes time taken to make the menu order and there is no follow up
|
Total kcal content of all food ordered (including sides, desserts)
|
15-20 minutes (the time frame denotes time taken to make the menu order and there is no follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2019
Primary Completion (ACTUAL)
November 30, 2019
Study Completion (ACTUAL)
November 30, 2019
Study Registration Dates
First Submitted
April 2, 2020
First Submitted That Met QC Criteria
April 6, 2020
First Posted (ACTUAL)
April 7, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 7, 2020
Last Update Submitted That Met QC Criteria
April 6, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 803194 1B2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Shared on the Open Science Framework
IPD Sharing Time Frame
On publication, indefinitely
IPD Sharing Access Criteria
Open website
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
Clinical Trials on Menu configuration (presence of energy labelling)
-
University of LiverpoolCompletedDiet, Healthy | Food SelectionUnited Kingdom
-
Universitaire Ziekenhuizen KU LeuvenCompleted
-
Missouri Department of Health and Senior ServicesRecruitingPneumonia | Diabetes | Periodontitis | Gingivitis | Periodontal Disease | Periodontal Infections | Oral Infections | Periapical InfectionsUnited States