NCT04961216

Brief Summary

This randomised controlled trial will test the effectiveness of a self-regulation intervention for reducing meat consumption in people who are motivated to change their meat-eating habits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

June 29, 2021

Last Update Submit

July 9, 2021

Conditions

Keywords

self-regulationself-monitoringgoal-settingmeat reductionmulti-component intervention

Outcome Measures

Primary Outcomes (1)

  • Change in mean daily meat consumption from baseline to follow-up 1, comparing intervention and control groups.

    Meat consumption was measured with meat-frequency questionnaires administered daily during the baseline week and follow-up 1.

    five weeks

Secondary Outcomes (8)

  • Change in mean daily meat consumption from baseline to follow-up 2, comparing intervention and control groups.

    nine weeks

  • Change in mean daily meat consumption from follow-up 1 to follow-up 2, comparing intervention and control groups.

    nine weeks

  • Change in mean daily consumption of meat subgroups from baseline to both follow-ups, comparing intervention and control groups.

    five and nine weeks

  • Change in meat-free self-efficacy from baseline to both follow-ups, comparing intervention and control groups.

    five and nine weeks

  • Change in participants meat-eating identity from baseline to both follow-ups, comparing intervention and control groups.

    five and nine weeks

  • +3 more secondary outcomes

Other Outcomes (2)

  • Outlier sensitivity analysis of primary outcome

    five weeks

  • Barriers to adherence to meat reduction actions

    five weeks

Study Arms (2)

OPTIMISE intervention

EXPERIMENTAL

After a baseline week of self-monitoring their meat consumption, participants will receive health and environmental feedback on their consumption and will be prompted to think about how they could reduce their intake. They will be asked to pre-select strategies from a list of meat consumption reduction actions and set themselves a meat reduction goal. During the following four weeks (weeks 2-5), participants will be asked every morning to log their meat consumption of the previous day, plan one of their chosen actions and formulate an if-then plan. Participants will receive weekly feedback on their achieved meat reduction in comparison to week 1. After the completion of the fifth week (follow-up 1), participants will be asked to continue performing the actions they found useful for the next four weeks (weeks 6-9). During the ninth week (follow-up 2) participants will be invited back to log their meat intake.

Behavioral: OPTIMISE

Control

NO INTERVENTION

After a baseline week of self-monitoring their meat consumption participants will be asked to try and reduce their meat consumption over the next eight weeks, with no further guidance. They will be invited back to complete log their meat consumption of the previous day during weeks five and nine (follow-up 1 and 2).

Interventions

OPTIMISEBEHAVIORAL

Self-regulation intervention

OPTIMISE intervention

Eligibility Criteria

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

You may qualify if:

  • Be willing and able to give informed consent
  • Be resident in the UK
  • Self report to speak English fluently
  • Self-report to eat meat at least five times per week
  • Be willing to reduce their meat intake
  • Have access to devices compatible with the delivery format of the intervention

You may not qualify if:

  • Enrolled in another dietary intervention study
  • Trying to lose weight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuffield Department of Primary Care Health Sciences, University of Oxford

Oxford, OX2 6GG, United Kingdom

Location

Related Publications (1)

  • Frie K, Stewart C, Piernas C, Cook B, Jebb SA. Effectiveness of an Online Programme to Tackle Individual's Meat Intake through SElf-regulation (OPTIMISE): A randomised controlled trial. Eur J Nutr. 2022 Aug;61(5):2615-2626. doi: 10.1007/s00394-022-02828-9. Epub 2022 Mar 4.

Related Links

MeSH Terms

Conditions

Feeding BehaviorSelf-Control

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorSocial Behavior

Study Officials

  • Susan A Jebb, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Individually randomised, two-arm, parallel-group randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Diet and Population Health

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 14, 2021

Study Start

March 15, 2021

Primary Completion

April 30, 2021

Study Completion

May 26, 2021

Last Updated

July 14, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available. All data is anonymous at the time of collection.

Locations