Keywords
health, values and preferences, red meat, processed meat, cross-sectional study, mixed methods
This article is included in the Agriculture, Food and Nutrition gateway.
This article is included in the Sociology of Health gateway.
This article is included in the Global Public Health gateway.
health, values and preferences, red meat, processed meat, cross-sectional study, mixed methods
We would like to thank the reviewers for taking the time to review our protocol (version 1) and for their comments. We have considered each comment in the new published version (version 2).
We would like to clarify that due to the COVID-19 pandemic, all sites are conducting the study remotely; only the pilot study was conducted in-person since it was implemented before the start of the pandemic.
We have improved the manuscript by clarifying the difference between the pilot study and the sites in which the study was actually conducted.
Further, given the pandemic, some changes in the study’s methods and procedures were made, which are now reported in the new published version of the protocol (version 2). For this reason, all methodological aspects related to the in-person interviews and questionnaire administration have been removed and only the online/remote procedures are instead explained and reported in the manuscript.
Additionally, we have corrected some errors in Table 1, we’ve clarified some procedurals aspects in the “Study procedures” section, and, finally, we have provided additional supplementary material as suggested by the reviewers.
See the authors' detailed response to the review by Tomás Meroño
See the authors' detailed response to the review by Mary Dicklin and Kevin Maki
Food choices are important for the overall health of each individual1. On a daily basis, people need to choose from a wide range of food in order to meet their nutritional requirements2. People’s dietary values and preferences influence the types of foods they consume, as well as the quantity of consumption3,4. However, nutritional guidelines have consistently ignored the systematic identification and incorporation of people’s values and preferences in the development of their recommendations5,6.
In light of recent studies showing an association between unprocessed red meat and processed meat consumption and adverse health outcomes, such as all-cause mortality, cardiovascular mortality, cancer risk, and stroke7–12, dietary guidelines have generally endorsed limiting meat intake (e.g. limiting processed meat)13–15. However, limited information exists regarding how much people value meat in their diet and their willingness to reduce meat consumption in the face of undesirable health effects16. Recently, an international panel of 14 members noted the low quality evidence supporting the causal relation of meat and adverse effects, and the small protective effect of reducing meat consumption if indeed such an effect exists. The panel formulated a weak recommendation in favor of continuing usual consumption17. The recommendation was also based on a systematic review of studies addressing peoples’ values and preferences regarding meat consumption; however, the evidence was also judged to be of low quality given identified issues with risk of bias and indirectness16.
We have therefore designed a study to evaluate adults’ values and preferences regarding meat intake and their willingness to change their consumption in the face of possible undesirable health consequences. Given the general importance of reducing cancer, the recent claims on cancer risk associated with meat consumption from the International Agency for Research in Cancer and the World Cancer Research Fund8,18, and in an attempt to avoid overwhelming participants with too much information, based on a systematic review of the literature11, we chose the risk estimates for two cancer outcomes to share with participants, specifically cancer incidence and cancer mortality.
This study is part of NutriRECS (Nutritional Recommendations; www.nutrirecs.com)19, an initiative that aims to: 1) apply rigorous systematic review and guideline methods using the GRADE approach to investigate the association between diets, foods and nutrients and health outcomes; 2) incorporate patient and community values and preferences to inform guideline recommendations; 3) apply strict and transparent management of conflicts of interest, and; 4) disseminate nutritional recommendations via open-access peer-reviewed publication.
We are conducting an international cross-sectional mixed-methods study including: i) a quantitative assessment through an online survey; ii) followed by a qualitative evaluation through semi-structured interviews and, iii) a follow-up quantitative assessment through a questionnaire in four three different sites in four three countries (Spain, Brazil, Canada and Poland). Study settings will include primary health care centers, universities, and the general community. The study began in 2019 with recruitment and data cleaning ongoing, with expected completion in early 2021. In 2019, we conducted a pilot study in a sample of 32 participants recruited in the general community in Nova Scotia and Prince Edward Island, Canada (20). The results and feedback of this pilot study were used to inform and improve the study’s procedures.
We will enroll adults 18 to 80 years of age who currently consume a minimum of three serving per week of either unprocessed red meat or processed meat. Unprocessed red meat is defined as mammalian meat (e.g. beef, pork, lamb), and processed meat is defined as white or red meat preserved by smoking, curing, salting, or by the addition of preservatives (e.g., hot dogs, charcuterie, sausage, ham, and cold cut deli meats)21. We will exclude adults who have active cancer; those who have severe cardiovascular disease (history of stroke, acute coronary syndrome, heart failure, and symptomatic peripheral arterial disease); those who are pregnant; and participants unwilling or unable to provide informed consent.
We will recruit convenience samples of participants from the general population or people studying or working at universities. We will recruit participants from the general population using social media postings on the Cochrane website, Twitter, and Facebook pages. We will recruit people studying or working at universities by email. The social media posting and the emails will include information on study’s details, eligibility criteria, contact information of the researcher carrying out the study, and the related link to access the online survey.
For the quantitative assessment, we have made a best estimate of the proportion willing to reduce their meat intake of approximately 0.5 using the response distribution results from our pilot study based on a proportion of 0.53 of pilot participants willing to reduce unprocessed red meat and 0.44 of participants willing to reduce processed meat20.We decided that a margin error around this estimate of as ± 0.1% is acceptable. We can achieve this precision with a 0.5 estimate in our primary outcome, the proportion of individuals ready to reduce or stop eating meat. Our sample size estimate is 96 participants at each site (95% confidence interval with ± 0.1% margin error)22,23.
For the qualitative evaluation, through a maximum variation sampling strategy, in each site, we will include participants until data saturation. Data saturation is achieved when no additional concepts emerge24. During data collection and analysis, if the research team determines that we have not reached data saturation, recruitment will be extended to include more participants until saturation is achieved. The maximum variation technique consists of the inclusion of a highly heterogeneous sample, and a description of the variability or dispersion for the relevant variables3,25. We will attempt to include an approximately equal number of participants with the following characteristics of these variables: gender (men and women); age (those between 18 to 66 years old, and those between 67 and 80 years older); education level (those with some high school or less, those with a high school degree, and those with a college degree) and willingness to stop or reduce meat consumption (willing ≥5 from the Likert-Scale and unwilling ≤4 from the Likert-Scale).
For the quantitative assessment, participants interested in participating will access the online survey and will be able to complete the questionnaire, including demographic characteristics, medical history information and meat consumption beliefs and behavior. The questionnaire will also include a direct choice exercise that will consist in presenting scenarios tailored to each individual’s typical weekly meat consumption. These scenarios will reflect the best estimate of absolute risk reduction in overall cancer incidence and cancer mortality over their lifetime based on our systematic review and dose-response meta-analysis11. This will allow us to assess participants’ willingness to: a) stop or b) reduce their unprocessed red meat and processed meat intake in the face of overall cancer incidence and cancer mortality risks.
After presenting participants with the cancer incidence scenario tailored to their consumption, participants will be asked regarding their willingness to stop their unprocessed red meat intake. If participants will be unwilling to stop (≤4 of the Likert-scale), they will be presented with an additional question about their willingness to reduce. Similarly, participants will be then presented with the cancer mortality scenario and related questions for unprocessed red meat. Finally, participants will be presented with the cancer incidence and mortality scenarios tailored to their processed meat consumption with the same logic of questions explained above.
Participants will be presented with both scenarios of unprocessed red meat and processed red meat. If participants declare to consume less than one serving of one type of meat per week, for example unprocessed red meat, they will skip the questions on red meat and will be presented with the scenarios and questions of processed meat only and vice versa. Finally, we will conduct a follow-up assessment, either by phone or by email, at three months to ask participants, who agreed to be contacted, if they have made any changes in their meat consumption.
Questionnaire. Based on our pilot study, we further developed and piloted a questionnaire in each site to collect the following data: age, sex, socioeconomic status, educational level, employment status, household size, religious beliefs, the presence of chronic and other health conditions, and family history of cancer, and meat consumption beliefs and behavior information. We asked both men and women with different educational backgrounds and of different ages (those between 18 to 66 years old, and those between 67 to 80 years older) to complete the questionnaire in order to identify ways of improving the content and/or structure of the questionnaire.
We will assess participants’ current weekly consumption of unprocessed red meat and processed meat. We will facilitate these questions related to their meat consumption habits by providing pictures illustrating types of meats and serving size to determine the typical number of servings they consume of each meat weekly. In addition, we will determine which factors participants take into account when choosing their diet, whether their food choices influence or are influenced by other people (e.g. preparing food for children) and to what extent they are satisfied with their current diet. See Extended data for the Spanish version of the online survey.
Serving size estimate and participant’s current meat consumption assessment. We estimated that each serving of unprocessed red meat is equal to 120g, and 50g for processed meat11. In Spain, the mean ± standard deviation of meat intake, according to 2016 Spanish National dietary survey in adults, conducted by the Spanish Agency for Consumption, Food Safety and Nutrition, is 37 ± 63g/day (2 servings/week) of unprocessed red meat and 32 ± 65g/day (4 servings/week) of processed meat26. In Brazil, according to the Health Survey conducted in São Paulo in 2008, the mean ± standard error of meat intake is 71 ± 2 g/day (4 servings/week) of unprocessed red meat and 28 ± 1 g/day (4 servings/week) of processed meat27. In Poland, according to the domestic deliveries and consumption report of 2017, the average intake of both unprocessed meat and processed meat is 115 g/day (9 servings/week)28. In Canada, according to the Statistics Canada’s Canadian Community Health Survey, the mean intake among Canadians is 52 g/day (3 servings/week) of unprocessed red meat and 22 g/day (3 servings/week) of processed red meat29. Based on these data, we defined the average intake of both unprocessed red meat and processed meat as 3 servings per weekto calculate the baseline risks of cancer incidence and cancer mortality. In order to assess participant’ current meat consumption, we determined the absolute risk reduction for all meat consumption frequency categories (servings/week) as follows: 3 to 4, 5 to 6, 7 to 8, 9 to 10, 11 to 12, 13 to 14, and more than 15 servings per week. We will report in servings per week their current meat consumption for both unprocessed red meat and processed meat.
Direct choice exercise. Following standard methodologies used in previous work in the field of obstetrics from members of our team30,31, we will use a direct choice experimental design to assess the proportion of people willing to change their consumption when faced with a risk reduction of overall cancer incidence and cancer mortality based on a seven point Likert- scale from 1 (meaning definitely not) to 7 (meaning definitely yes). To ensure that participants have a similar understanding of these two outcomes, we will describe the development of each outcome through the use of health states examples (Table 1 and Table 2). We will present our data from our systematic review that addressed the possible impact of reducing meat intake on overall cancer incidence and mortality11. We will first present the baseline risk and the risk reduction participants might achieve by stop eating meat and its certainty. We will develop an interactive electronic decision aid using MagicApp software (http://magicproject.org/research-projects/share-it/) to show the probabilities of reducing the risk of overall cancer incidence and overall cancer mortality if participants’ would stop eating unprocessed red or processed meat (three servings/week scenarios in Figure 1 for processed meat and Figure 2 for unprocessed red meat intake – see Extended data32 for all servings/week scenarios ). In addition to the risk reductions, the overall certainty of evidence based on the GRADE approach for cancer incidence and mortality will be shared with the participant33. For the direct choice exercise in the online survey, we will provide an explanatory video that will describe to participants how to read and interpret the data presented in the scenarios. In addition, we will provide participants with explicit text tailored to their average weekly meat consumption. If participants are unwilling to stop eating meat to achieve the possible associated health benefits, we will ask them if they would be willing to reduce their meat intake but remind them that the cancer risk reduction, they might anticipate will be less by reducing their meat intake then stopping completely.
Semi-structured interview. We will also develop and pilot a script in each site for a semi-structured interview. We will conduct these interviews in order to explore peoples’ motives regarding their willingness to change their meat consumption. Based on our pilot study, interviews will take approximately 30 minutes. See Extended data for the Semi-structured interview script.
Follow-up assessment. We will contact participants by phone or by email three months after the online survey and ask them if they have made any changes in their meat consumption. In case of the phone follow-up, we will follow a semi-structured telephone script previously piloted; in instances where participants prefer to be contacted by email, we will send them a questionnaire with the same content we will use for the phone interview. See Extended data for the Follow-up assessment script.
The primary outcome measure for all included participants will be willingness to change meat consumption in the face of the undesirable cancer health risks. We will show participants the cancer risk reduction they may achieve if they would stop eating unprocessed red meat or processed meat tailored to their weekly consumption and ask them if they are willing to stop, on a scale from 1 (meaning “definitely not”) to 7 (meaning “definitely yes”). If participants are not willing to stop eating meat (≤4 from the Likert-scale), we will ask them if they will be willing to reduce any amount of their weekly meat intake, on a scale from 1 (meaning definitely not) to 7 (meaning definitely yes). As a secondary outcome, we will explore participants’ values and preferences regarding meat intake and the related motives around their willingness or unwillingness to make any changes. We will ask participants in the qualitative evaluation, which factors determine their unprocessed red meat or processed meat intake, and to what extent these factors influence their willingness/unwillingness to stop/reduce their meat consumption. Finally, we will estimate their meat consumption at three months after the online survey and determine if they have made any changes.
Quantitative analysis. We will describe participants’ demographic and medical history information as well as meat consumption behaviors using means and standard deviations or frequencies and proportions, as appropriate.
We will describe the distribution of the continuous dependent variables: a) “willingness to stop unprocessed red meat consumption in the face of cancer incidence risk”; b) “willingness to stop unprocessed red meat consumption in the face of cancer mortality risk”; c) “willingness to reduce unprocessed red meat consumption in the face of cancer incidence risk”; d) “willingness to reduce unprocessed red meat consumption in the face of cancer mortality risk”, by presenting histograms and using means and standard deviations or median and IQR, as appropriate. We will do the same analysis for processed meat. Then, we will conduct an exploratory linear regression analysis using the above dependent variables and the participants’ characteristics (sex, age, level of education, occupational status, religious belief, and family history of cancer) as the independent variables. We will calculate the beta coefficients and the associated 95% confidence interval of participants who are willing to avoid, and for those willing to reduce unprocessed red meat and processed meat consumption in the face of undesirable cancer risks.
Additionally, we will conduct an exploratory logistic regression analysis using the dependent variables on willingness as categorical variables: those willing (≥5 from the Likert-Scale) and unwilling (≤4 from the Likert-Scale). We will calculate the odds ratio and the associated 95% confidence interval of participants who are willing to avoid and reduce meat consumption in the face of undesirable cancer risks.
Using our three-month follow-up assessment data, we will calculate the frequency and proportion of participants who made any changes in their meat consumption.
Qualitative analysis. We will audio-record and transcribe verbatim all semi-structured interviews and use thematic analysis for the qualitative analysis34,35. For our iterative analysis, we will use constant comparison within and across cases to identify any patterns. We will code all transcripts and then the codes will be sorted into themes. We will subsequently compare the identified themes with demographic and participant characteristic information collected to demonstrate any patterns among groups such as sex, age, and education level.
Integrating qualitative and quantitative analyses. We will conduct a sequential analysis of the quantitative and qualitative components of the data. We will analyze each dataset separately and then, at the end of the study, draw meta-inferences informed by the findings from both data sets. We expect the qualitative results to provide a better understanding of the decision-making process than if the quantitative results were considered alone.
Research approval was obtained by the Research Ethics Board, Dalhousie University (Canada; 2019-4715), the Clinical Research Ethics Committee of the Jordi Gol University Institute for Primary Care Research (IDIAP; Spain; 19/121-P), the Bioethics Committee of the Jagiellonian University (Poland; 1072.6120.141.2019), and the National Research Ethics Commission (Brazil; CAAE 21826419.4.0000.8527), and if needed will be obtained from all other participating sites. We will explain the entire process of the study to the participants and we will present the potential benefits and risks of participation. The potential benefits of this study to participants include gaining an understanding of the current research regarding overall cancer mortality and incidence based on an up to date high quality dose-response systematic review and meta-analysis11, which participants could use in future dietary decisions. There are no potential physical or psychological risks to participating in this study.
Participation in the study is voluntary and participants may withdraw from the study at any time without penalty. Should they choose to withdraw; participants will decide whether they want us to discard all or some of the data they have provided. Participants willing to participate will have to sign a written consent form, and they will be assigned a number to anonymize all data collected. Consent forms will be kept separately in a secure cabinet. All interviews will be audio-recorded and transcribed onto a computer file. The recording device will be stored in a secure cabinet and the recordings will be deleted upon completion of the study. Participants will not be identified by name nor otherwise identified when research results are shared. It is possible that a participant could be quoted to highlight results, however, they will be anonymized and neither their name, nor their assigned alphanumeric code, will be shared. Participants will be made aware of this possibility during the consent process and may, if they wish, choose not to allow the use of direct quotations. No compensation will be provided to participants. We will share with participants a copy of our published final results by email or by postal service.
We will adhere to the checklist of good practice in the conduct and reporting of survey research36 when reporting our results. Results will be disseminated through publications and presentations.
Our international mixed-methods study will be the first to explicitly explore peoples’ health-related values and preferences, and their willingness to stop and/or reduce meat consumption when informed of the potential adverse cancer risk, and the uncertainty around this evidence. The information patients will receive will be based on a recent systematic review and dose-response meta-analysis11.
Because there is limited information in the literature on how people value their health in relation to their diet, developing nutritional recommendations based on health-related values and preferences of community members is a major challenge. Previous studies addressing people’s meat preferences did not adequately present the undesirable health effects of meat consumption in ways that captured the current evidence and its uncertainty37,38.
In the context of the NutriRECS initiative, our team conducted a systematic review that summarized evidence that omnivores are attached to meat and are reluctant to reduce their meat consumption. However, we rated the certainty of evidence as low due to issues with risk of bias, indirectness, and because of the small number of participants and limited information regarding data analysis16.
A NutriRECS international panel using an individual patient perspective formulated a weak recommendation in favor of continuing current unprocessed red meat and processed meat consumption, acknowledging the low certainty regarding the values and preferences evidence17. This experience triggered the design of the present study, aiming to overcome the limitations of the studies to date16.
Our study has some potential limitations. Our sample includes participants living in high-income countries or from high income strata in low to middle income countries. Therefore, we cannot generalize these findings to low-income populations. We will, however, collect information on participants’ socioeconomic status and education level in order to explore the effect of these characteristics on participants’ dietary values and preferences.
A second limitation of our study is the exclusive focus on cancer outcomes, despite evidence suggesting that reducing meat consumption may reduce the risk of diabetes and cardiovascular outcomes12,39. However, due to the recent claims of meat consumption and cancer risks8,40, the inconsistency in data on cardiometabolic risk associated with both unprocessed and processed meat10,39, and to not overburden participants with too much information, we prioritized two cancer outcomes.
Regarding strengths of our study design, we will address some of the limitations in the previous studies by following a systematic and transparent approach with the use of questionnaires, direct choice exercises and open-ended questions to assess peoples’ health values in relation to their unprocessed red meat and processed meat consumption. We will inform people of the most recent evidence of meat consumption and its related cancer risks11, including the certainty of evidence for these risks, according to their current weekly average consumption. In addition, we will explore their willingness to make any changes to their diet based on the potential risk reduction in cancer.
Our international multicentre study will help ensure generalizability of the results. In addition, the collection of both quantitative and qualitative data will enable an accurate identification of the current health values and preferences regarding meat consumption. In addition to our initial pilot study20, we have further piloted the questionnaires and scripts in each center among both men and women, both with different educational backgrounds, and of different ages to ensure readability and understandability in the general population. We have trained research staff and we will monitor study procedures to ensure quality implementation throughout the interview process. Ultimately, we will follow-up participants to determine if they have made any changes in their meat consumption according to what they have reported during the initial interview; this will allow us to assess the consistency and reliability of our study findings.
Our international study has direct implications for decision makers, guideline developers and policy makers in the development of nutritional recommendations. Up to now, this aspect has been neglected when formulating recommendations. Panels will now have access to international research evidence on values and preferences specific to actual estimated risk reductions in cancer, and the relevant certainty, associated with decreased meat intake. Based on international GRADE standards41, this information will prove crucial for guideline panels moving from the evidence to recommendations on red and processed meat.
One potential area of further research will be the evaluation of how panels are using this new evidence when formulating recommendations. This work will also inform clinicians regarding community values and preferences when considering the implementation of diet related changes with their patients. Our proposal will use innovative approaches to assess people’s health values and preferences in relation to their diet. The study will provide a rigorous and transparent methodology that can be further utilized in the context of other nutritional scenarios.
Open Science Framework: https://doi.org/10.17605/OSF.IO/4HKXQ32.
Spanish version of the online survey available here.
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
This study will be conducted using MagicApp software (http://magicproject.org/research-projects/share-it/). MAGIC (Making GRADE the Irresistible Choice) is a non-profit Foundation, aiming to increase value and reduce waste in healthcare through a digital and trustworthy evidence ecosystem. MAGICapp is the core platform in the evidence ecosystem bringing digitally structured guidelines, evidence summaries and decision aids to clinicians and patients.
Claudia Valli is a doctoral candidate for the PhD in Methodology of Biomedical Research and Public Health (Department of Paediatrics, Obstetrics, Gynaecology and Preventive Medicine), Universidad Autònoma de Barcelona, Barcelona, Spain.
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Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Nutrition, nutritional epidemiology.
Competing Interests: Received research funding from the National Cattlemen's Beef Association/Beef Checkoff.
Reviewer Expertise: Design and conduct of clinical studies in human nutrition, metabolism and chronic disease risk factor management.
Is the rationale for, and objectives of, the study clearly described?
Yes
Is the study design appropriate for the research question?
Yes
Are sufficient details of the methods provided to allow replication by others?
Partly
Are the datasets clearly presented in a useable and accessible format?
Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Nutrition, nutritional epidemiology.
Is the rationale for, and objectives of, the study clearly described?
Yes
Is the study design appropriate for the research question?
Partly
Are sufficient details of the methods provided to allow replication by others?
Partly
Are the datasets clearly presented in a useable and accessible format?
Not applicable
Competing Interests: Received research funding from the National Cattlemen's Beef Association/Beef Checkoff.
Reviewer Expertise: Design and conduct of clinical studies in human nutrition, metabolism, and chronic disease risk factor management.
Alongside their report, reviewers assign a status to the article:
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Version 1 11 May 20 |
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