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

Diet Habit Clinical Trial

— OPTIMISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04961216
• Other study ID #: R71398/RE002
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: May 26, 2021

Study information

• Verified date: July 2021
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: May 26, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diet Habit

Intervention

Behavioral:
• OPTIMISE
Self-regulation intervention

Locations

Country	Name	City	State
United Kingdom	Nuffield Department of Primary Care Health Sciences, University of Oxford	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Outlier sensitivity analysis of primary outcome	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
Other	Barriers to adherence to meat reduction actions	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
Primary	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	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.	nine weeks
Secondary	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.	nine weeks
Secondary	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.	five and nine weeks
Secondary	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".	five and nine weeks
Secondary	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	five and nine weeks
Secondary	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.	nine weeks
Secondary	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.	five weeks
Secondary	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.	nine weeks

External Links

•   Pre-published statistical analysis plan