- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04961216
The OPTIMISE Intervention for Reducing Meat Consumption in UK Adult Meat-eaters (OPTIMISE)
Effectiveness of an Online Programme to Tackle Individual's Meat Intake Through SElf-regulation (OPTIMISE): A Randomised Controlled Trial
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oxford, United Kingdom, OX2 6GG
- Nuffield Department of Primary Care Health Sciences, University of Oxford
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
|---|---|
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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
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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).
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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
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Meat consumption was measured with meat-frequency questionnaires administered daily during the baseline week and follow-up 1.
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five weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in mean daily meat consumption from baseline to follow-up 2, comparing intervention and control groups.
Time Frame: nine weeks
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Meat consumption was measured with meat-frequency questionnaires administered daily during the baseline week and follow-up 2.
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nine weeks
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Change in mean daily meat consumption from follow-up 1 to follow-up 2, comparing intervention and control groups.
Time Frame: nine weeks
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Meat consumption was measured with meat-frequency questionnaires administered daily during follow-up 1 and follow-up 2.
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nine weeks
|
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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
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Meat subgroups assessed: red meat, processed meat, and red & processed meat.
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five and nine weeks
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Change in meat-free self-efficacy from baseline to both follow-ups, comparing intervention and control groups.
Time Frame: five and nine weeks
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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
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Change in participants meat-eating identity from baseline to both follow-ups, comparing intervention and control groups.
Time Frame: five and nine weeks
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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
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Comparison of actions taken by the control group participants and those taken by the intervention group.
Time Frame: nine weeks
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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.
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nine weeks
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Acceptability of the self-regulation intervention for reducing meat consumption
Time Frame: five weeks
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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
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Percentage of meat frequency questionnaires completed by participants
Time Frame: nine weeks
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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
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Outlier sensitivity analysis of primary outcome
Time Frame: five weeks
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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.
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five weeks
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Barriers to adherence to meat reduction actions
Time Frame: five weeks
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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."
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five weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan A Jebb, PhD, University of Oxford
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R71398/RE002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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