The OPTIMISE Intervention for Reducing Meat Consumption in UK Adult Meat-eaters (OPTIMISE)

July 9, 2021 updated by: ProfessorSusanJebb, University of Oxford

Effectiveness of an Online Programme to Tackle Individual's Meat Intake Through SElf-regulation (OPTIMISE): A Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An individually randomised, two-arm, parallel-group design will be employed, assessing superiority of the self-regulation intervention over a control. The intervention aims to support individuals in self-monitoring their meat consumption, learning about the impact of their food choices on their health and the environment and setting personal meat reduction goals as well as implementing those goals to reduce meat consumption in manageable steps.

After a baseline week of self-monitoring meat consumption, the intervention will be delivered over four weeks, followed by a four-week long maintenance phase.The study will be delivered remotely through our bespoke website developed specifically for the intervention.

All participants will complete a baseline questionnaire that asks about their demographic characteristics, assesses their self-efficacy regarding consumption of meat-free dishes and asks about their meat-eating identity. Participants will be then randomised 1:1 to the control or intervention group. During the baseline week (week 1, days 2-5), participants will be invited to complete a meat frequency questionnaire, daily, each time looking back at the previous day. After the baseline week, participants will follow their assigned condition for eight weeks. In the control condition, participants will be asked to try and reduce their meat intake, without further guidance. In the intervention condition, participants will be guided through an experimentation process for the first four weeks. This includes setting a meat reduction goal, tracking meat intake daily, planning and implementing an action to reduce meat intake daily and evaluating those actions weekly. After these four weeks (weeks 2-5), intervention group participants will enter a four-week long maintenance phase during which they will be asked to continue with the actions they found useful in the previous weeks. During the fifth and ninth weeks, all participants will be invited to complete the meat frequency questionnaire daily. On the last day of both the fifth and ninth weeks, participants will be asked to complete the self-efficacy and meat-identity questionnaires used in the baseline session again. On the last day of the fifth-week participants of the intervention condition will be further asked to complete a questionnaire to evaluate the intervention. On the last day of the ninth-week participants of the control condition will be asked what kinds of strategies they used to actively reduce their meat intake in the last eight weeks.

Study Type

Interventional

Enrollment (Actual)

151

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

      • Oxford, United Kingdom, OX2 6GG
        • Nuffield Department of Primary Care Health Sciences, University of Oxford

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OPTIMISE intervention

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.

Self-regulation intervention
No Intervention: Control
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean daily meat consumption from baseline to follow-up 1, comparing intervention and control groups.
Time Frame: five weeks
Meat consumption was measured with meat-frequency questionnaires administered daily during the baseline week and follow-up 1.
five weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean daily meat consumption from baseline to follow-up 2, comparing intervention and control groups.
Time Frame: nine weeks
Meat consumption was measured with meat-frequency questionnaires administered daily during the baseline week and follow-up 2.
nine weeks
Change in mean daily meat consumption from follow-up 1 to follow-up 2, comparing intervention and control groups.
Time Frame: nine weeks
Meat consumption was measured with meat-frequency questionnaires administered daily during follow-up 1 and follow-up 2.
nine weeks
Change in mean daily consumption of meat subgroups from baseline to both follow-ups, comparing intervention and control groups.
Time Frame: five and nine weeks
Meat subgroups assessed: red meat, processed meat, and red & processed meat.
five and nine weeks
Change in meat-free self-efficacy from baseline to both follow-ups, comparing intervention and control groups.
Time Frame: five and nine weeks

Self-efficacy was measured using three items from the self-efficacy scale Lacroix & Gifford (2019):

"I lack the cooking skills to prepare meat-free meals" "I don't know what to eat instead of meat" "I don't have enough willpower to not eat meat"

Answers were given on a 7-point Likert scale ranging from (1) "strongly disagree" to 7 "strongly agree".

five and nine weeks
Change in participants meat-eating identity from baseline to both follow-ups, comparing intervention and control groups.
Time Frame: five and nine weeks

Meat identity questionnaire was used to categorise people as follows: 1) meat-eating identity, 2) reduced meat-eating identity, and 3) non-meat eating identity.

Participants who moved from 1 to 2, 1 to 3, or 2 to 3 were coded as positive meat-identity change=1 and other changes/no change were coded as positive meat-identity change=0

five and nine weeks
Comparison of actions taken by the control group participants and those taken by the intervention group.
Time Frame: nine weeks
Control group participants completed a questionnaire at follow-up 2 which asked what strategies they had tried to reduce their meat consumption. Reponses were free-text and explored qualitatively. We assessed which meat reduction actions were chosen by our intervention group participants and compared these to those reported by the control group.
nine weeks
Acceptability of the self-regulation intervention for reducing meat consumption
Time Frame: five weeks

Acceptability was assessed with an intervention evaluation questionnaire administered at follow-up 1 to intervention group participants.

The questionnaire asked participants to rate the usefulness of individual intervention components (tracking meat consumption daily, health/environmental feedback, action planning) and additional resources (weekly action evaluation, downloadable action diary, downloadable action overview, links to other resources, ability to review your journey) on a scale of 1 (not useful) to 10 (very useful). We also asked if participants had any additional feedback - this was a free-text question and responses were coded and analysed qualitatively.

five weeks
Percentage of meat frequency questionnaires completed by participants
Time Frame: nine weeks

Intervention group participants could complete a maximum of 42 meat frequency questionnaires (daily weeks 1-5 and 9) over the study period, while control group participants could complete a maximum of 21 meat frequency questionnaires (daily weeks 1, 5 and 9). For each participant we calculated their percentage of meat frequency questionnaires submitted (i.e. X/42* 100 or X/21* 100).

We then looked at the percentage of participants who completed all sessions, and at least 80% of sessions, in both groups.

nine weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outlier sensitivity analysis of primary outcome
Time Frame: five weeks
We ran a sensitivity analysis repeating the primary analysis (change in mean daily meat consumption from baseline to follow-up 1) excluding days in which participant total meat intake exceeded 1.5 kg (measured by the meat frequency questionnaires) to assess the effect of outliers.
five weeks
Barriers to adherence to meat reduction actions
Time Frame: five weeks
Barriers were identified by open-text responses to daily (Weeks 2-5) action completion question when participants indicated they didn't stick to their action: "Please tell us a little bit more about why you were unable to stick to the action you had planned."
five weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susan A Jebb, PhD, University of Oxford

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)

March 15, 2021

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

May 26, 2021

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

July 9, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 9, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

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.

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