Diet HabitOPTIMISENCT04961216
The OPTIMISE Intervention for Reducing Meat Consumption in UK Adult Meat-eaters
A study testing OPTIMISE in people with Diet Habit, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet Habit
- What is being tested?
- OPTIMISE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2021to 26 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Enrolled in another dietary intervention study
- Trying to lose weight
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nuffield Department of Primary Care Health Sciences, University of Oxford
Oxford, OX2 6GG
About this study
Official title: 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.
Read the 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.
- Conditions
- Diet Habit
- Being tested
- OPTIMISE
- Keywords
- self-regulation, self-monitoring, goal-setting, meat reduction, multi-component intervention
- Medical subject headings
- Feeding Behavior, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIMISEBehavioural
Self-regulation intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: five weeks
Secondary outcomes (8)
Change in mean daily meat consumption from baseline to follow-up 2, comparing intervention and control groups.
Meat consumption was measured with meat-frequency questionnaires administered daily during the baseline week and follow-up 2.
Measured: nine weeks
Change in mean daily meat consumption from follow-up 1 to follow-up 2, comparing intervention and control groups.
Meat consumption was measured with meat-frequency questionnaires administered daily during follow-up 1 and follow-up 2.
Measured: nine weeks
Change in mean daily consumption of meat subgroups from baseline to both follow-ups, comparing intervention and control groups.
Meat subgroups assessed: red meat, processed meat, and red \& processed meat.
Measured: five and nine weeks
Change in meat-free self-efficacy from baseline to both follow-ups, comparing intervention and control groups.
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".
Measured: five and nine weeks
Change in participants meat-eating identity from baseline to both follow-ups, comparing intervention and control groups.
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
Measured: five and nine weeks
Comparison of actions taken by the control group participants and those taken by the intervention group.
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.
Measured: nine weeks
Acceptability of the self-regulation intervention for reducing meat consumption
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.
Measured: five weeks
Percentage of meat frequency questionnaires completed by participants
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.
Measured: nine weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start15 Mar 2021
- Primary completion30 Apr 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individually randomised, two-arm, parallel-group randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ProfessorSusanJebb, University of Oxford
- Investigators
- Susan A Jebb, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961216
- Sponsor's protocol ID
- R71398/RE002
- Acronym
- OPTIMISE
- Status last verified
- Jul 2021
- First submitted
- 29 Jun 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available. All data is anonymous at the time of collection.
Publications
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.
PubMed 35244757
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Online Programme to Tackle Individual's Meat Intake Through SElf-regulation (OPTIMISE): A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04961216
- Acronym / sponsor ID
- OPTIMISE / R71398/RE002
- Conditions
- Diet Habit
- Keywords
- self-regulation, self-monitoring, goal-setting, meat reduction, multi-component intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Individually randomised, two-arm, parallel-group randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| OPTIMISE intervention | Experimental | Behavioral: OPTIMISEAfter 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Enrolled in another dietary intervention study
- Trying to lose weight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPTIMISESelf-regulation intervention | Behavioural | OPTIMISE intervention |
Primary outcome
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.
8 secondary outcomes
Change in mean daily meat consumption from baseline to follow-up 2, comparing intervention and control groups.
Time frame: 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
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
Change in meat-free self-efficacy from baseline to both follow-ups, comparing intervention and control groups.
Time frame: 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
Comparison of actions taken by the control group participants and those taken by the intervention group.
Time frame: nine weeks
Acceptability of the self-regulation intervention for reducing meat consumption
Time frame: five weeks
Percentage of meat frequency questionnaires completed by participants
Time frame: nine weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Derived from this study: PubMed 35244757Frie 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.
- Pre-published statistical analysis planLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available. All data is anonymous at the time of collection.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan A Jebb, PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPTIMISE in people with Diet Habit, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean daily meat consumption from baseline to follow-up 1, comparing intervention and control groups. (time frame: five weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04961216, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.