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

Sponsor
University of Oxford (Other)
Overall Status
Completed
CT.gov ID
NCT04961216
Collaborator
(none)
151
1
2
2.4
63.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: OPTIMISE
N/A

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

Study Type:
Interventional
Actual Enrollment :
151 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Individually randomised, two-arm, parallel-group randomised controlled trialIndividually randomised, two-arm, parallel-group randomised controlled trial
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Effectiveness of an Online Programme to Tackle Individual's Meat Intake Through SElf-regulation (OPTIMISE): A Randomised Controlled Trial
Actual Study Start Date :
Mar 15, 2021
Actual Primary Completion Date :
Apr 30, 2021
Actual Study Completion Date :
May 26, 2021

Arms and Interventions

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.

Behavioral: OPTIMISE
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).

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

  1. Change in mean daily meat consumption from baseline to follow-up 2, comparing intervention and control groups. [nine weeks]

    Meat consumption was measured with meat-frequency questionnaires administered daily during the baseline week and follow-up 2.

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

    Meat consumption was measured with meat-frequency questionnaires administered daily during follow-up 1 and follow-up 2.

  3. Change in mean daily consumption of meat subgroups from baseline to both follow-ups, comparing intervention and control groups. [five and nine weeks]

    Meat subgroups assessed: red meat, processed meat, and red & processed meat.

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

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

  6. Comparison of actions taken by the control group participants and those taken by the intervention group. [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.

  7. Acceptability of the self-regulation intervention for reducing meat consumption [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.

  8. Percentage of meat frequency questionnaires completed by participants [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.

Other Outcome Measures

  1. Outlier sensitivity analysis of primary outcome [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.

  2. Barriers to adherence to meat reduction actions [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."

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nuffield Department of Primary Care Health Sciences, University of Oxford Oxford United Kingdom OX2 6GG

Sponsors and Collaborators

  • University of Oxford

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
ProfessorSusanJebb, Professor of Diet and Population Health, University of Oxford
ClinicalTrials.gov Identifier:
NCT04961216
Other Study ID Numbers:
  • R71398/RE002
First Posted:
Jul 14, 2021
Last Update Posted:
Jul 14, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ProfessorSusanJebb, Professor of Diet and Population Health, University of Oxford

Study Results

No Results Posted as of Jul 14, 2021