NCT04893213

Brief Summary

This study will examine the effectiveness of a structural intervention (baseline proportion of lower energy ready meals vs increased proportion of lower energy ready meals) on calories (kcal) ordered and consumed. The study will use a within-subjects design, meaning all participants will be exposed to both conditions (baseline vs increased lower energy meal menus). The procedure will involve participants placing orders for supermarket ready meals, which are then delivered to their homes for their consumption. This study will also investigate whether the effectiveness of the intervention varies, depending on socioeconomic position (SEP). The primary hypothesis is that increasing proportion of lower energy options will decrease total kcal ordered and consumed, and that there will be no difference between higher and lower SEP. To address the limited evidence on longer term impacts of dietary interventions on daily energy intake, the present study will also examine post-meal energy consumption up to midnight on the following day. Finally, this study will explore the psychological processes that might underlie the effectiveness of the intervention among individuals with higher and lower SEP; namely, food choice motives, satiety responsiveness, plate clearing tendencies, and food waste concerns.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

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

April 13, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2021

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

May 10, 2021

Last Update Submit

May 11, 2022

Conditions

Keywords

availabilitysocio-economic positionfood choiceeating behaviour

Outcome Measures

Primary Outcomes (2)

  • Total meal energy (kcal) ordered

    Calculated as the sum of the kcal content of the main and side ordered

    20 minutes (the time frame denotes time taken to complete the initial study questionnaire and make the food choices)

  • Total meal energy (kcal) consumed

    Calculated as the sum of the kcals consumed from the main and side combined

    Once the food has been delivered, the time frame is up to 72 hours

Secondary Outcomes (1)

  • Post-meal intake (kcal)

    Measured 24-30 hours after study meal is consumed

Study Arms (2)

Baseline availability

ACTIVE COMPARATOR

Baseline availability of lower energy meal options

Other: Manipulation of availability of lower energy meal options

Increased availability

EXPERIMENTAL

Increased availability of lower energy meal options

Other: Manipulation of availability of lower energy meal options

Interventions

Menus provided differ in % of menu options that are higher vs. lower in energy

Baseline availabilityIncreased availability

Eligibility Criteria

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

You may qualify if:

  • UK (United Kingdom) residents, aged 18 or over
  • Fluent in English
  • Have access to a phone/tablet/computer device which has access to Internet and a functioning camera
  • Willing to consume two supermarket ready meals
  • Have access to a functioning microwave and oven for the preparation of the ready meals

You may not qualify if:

  • Taking part more than once
  • Another member of the same household has participated in the study (Multiple members of the same household will not be allowed to take part)
  • Current or historic diagnosed eating disorders
  • Currently on any medication which affects appetite
  • Any of the following dietary restrictions, intolerances, or allergies (Vegetarian, vegan, gluten-free, sugar-free, dairy/lactose-free, food allergy - such as milk, eggs, nut, wheat, fish, etc)
  • History of severe childhood allergies, anaphylaxis or anaphylactic shock

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 PreferencesObesityFeeding Behavior

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, Animal

Study Officials

  • Eric Robinson, PhD

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader in Psychological Sciences

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 19, 2021

Study Start

April 13, 2021

Primary Completion

July 5, 2021

Study Completion

July 5, 2021

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Shared on the Open Science Framework (OSF)

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

Available IPD Datasets

Study Protocol Access
Statistical Analysis Plan Access
Individual Participant Data Set Access

Locations