Environmental Harm Menu Labels and the Healthfulness of Real-World Fast-Food Orders (MENU)
Longitudinal Trial Evaluating the Effect of Environmental Harm Menu Labels on the Healthfulness of Real-World Fast-Food Meal Orders
The primary objective of this study is to evaluate whether repeated exposure to environmental harm menu labels on fast-food restaurant menus improves the healthfulness of real-world fast-food meal orders. Participants will be randomized to view either a control (QR code) label or traffic-light style environmental harm labels on two alternating fast-food restaurant menus, and will order one lunch per week for seven weeks through a study ordering website, with each meal delivered to the participant the following day.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
Fast-food restaurants, where more than one-third of Americans eat on a typical day, are an important setting for dietary interventions aimed at reducing nutrition-related chronic diseases. Prior research on eco-labels, including this team's preliminary studies, has tested labels in online randomized experiments in which food choices are hypothetical. This trial tests the degree to which repeated exposure to environmental harm labels on fast-food menus promotes healthier food choices over time in a real-world setting in which participants receive and consume the foods the participant chooses.
A total of 450 adults aged 18 to 64 years who consume fast food at least twice per month will be recruited from the greater Baltimore/Washington, D.C. metropolitan area. Participants will be randomized 1:1 into two groups (approximately 225 per group) using a computer-generated simple randomization sequence, to view one of two labels: control QR code label vs. traffic-light style environmental harm labels with the sequence in which the two restaurant menus are presented during the ordering period also randomized 1:1. The environmental harm labels were identified through preliminary studies within the parent project, which tested ecolabel text, designs, and schemes for effectiveness in increasing the healthfulness of hypothetical fast-food meal orders.
Over seven weeks, participants will order one lunch per week from a website designed to imitate the experience of ordering fast food using a commercial online platform. Menus alternate each week between a burger restaurant and a sandwich restaurant, with the starting menu randomized. In Week 1, all participants order from an unlabeled menu, establishing a within-person baseline; in Weeks 2-7, participants view menus with the participants randomized label condition applied to the main item menus. Each meal selected is delivered to the participant the following day via a third-party food delivery service coordinated by study staff. Participants must order at least one main item and must spend a minimum amount of a predetermined meal budget on each order, with unspent funds returned at the end of the study, to reflect real-world cost trade-offs in food choice.
Participants will complete brief online surveys at baseline and endline. The baseline survey collects demographics, food security status, food-related behaviors, and personal health; the endline survey collects participants' experience with the ordering task, perceptions of the menus and food ordered, experience with the label condition to which the participants were randomized, fast-food consumption outside of study-provided lunches, knowledge of the environmental impact of foods, and current food security status.
The primary outcome is the healthfulness of food selections during the weekly meal orders, measured with a modified Nutrient Profile Index score. Secondary outcomes include selection of a beef item, the total energy of the order, and other nutrients of the order. All study activities are conducted remotely; there are no in-person study visits.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Nina Carr, MPH, MBA
- Telefonszám: 240-405-2823
- E-mail: ncarr6@jhu.edu
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Julia Wolfson, PhD, MPP
- Telefonszám: 213-359-2915
- E-mail: jwolfso7@jhu.edu
Tanulmányi helyek
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Maryland
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Baltimore, Maryland, Egyesült Államok, 21205
- Toborzás
- Johns Hopkins Bloomberg School of Public Health
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Kapcsolatba lépni:
- Nina Carr, MPH, MBA
- Telefonszám: 240-405-2823
- E-mail: ncarr6@jhu.edu
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Kutatásvezető:
- Julia Wolfson, PhD, MPP
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Aged 18 to 64 years
- Consumes fast food two or more times per month
- Willing to eat meat
- Lives or works within the greater Washington, D.C./Baltimore metropolitan area, defined as the counties and county equivalents within the Baltimore-Columbia-Towson, MD and Washington-Arlington-Alexandria, DC-VA-MD-WV Core Based Statistical Areas (excluding Jefferson County, West Virginia)
- Has access to the internet during the daytime
- Has access to an internet-capable device (smartphone, tablet, or computer)
- Able to send and receive phone calls and text messages at a unique primary phone number (number if not affiliated with a separate prospective or enrolled participant record)
- Available to receive a weekly lunch delivery one day per week (Tuesday-Friday, 11:00 am - 3:00 pm) for seven weeks at a consistent address within the sample frame (this includes screening for potentially disruptive travel plans during ordering period)
- Within the delivery zone for both restaurants in the study
- Willing to complete training on lunch ordering procedures
- Willing and able to complete dietary recalls and surveys
Exclusion Criteria:
- Under 18 years of age
- Over 64 years of age
- Consumes fast food fewer than two times per month
- Pescatarian, vegetarian, or vegan (due to menu content)
- Lives and works outside of the greater Washington, D.C./Baltimore metropolitan area
- Lacks access to the internet during the daytime
- Lacks access to an internet-capable device
- Unable to send and receive phone calls and text messages at a unique primary phone number (phone number is affiliated with a separate prospective or enrolled participant record)
- Lives or works outside the delivery zone for either or both study restaurants
- Unavailable to receive seven weeks of consecutive lunch deliveries on a selected day Tuesday through Friday between 11:00 am and 3:00 pm at a consistent address within the sample frame
- Unwilling to complete training on lunch ordering procedures
- Unwilling or unable to complete dietary recalls and surveys
- Fails verification via Cloudfare Turnstile check when accessing REDCap Interest Survey
- Answers the hidden bot-detection question embedded in the Interest Survey
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Placebo Comparator: Control Label
Participants order one lunch per week for seven weeks from two alternating fast-food restaurant menus. The Week 1 menu is unlabeled. In Weeks 2-7, a control label consisting of a QR code is applied to all main items on the restaurant menus. Participants in this arm are randomized in equal numbers to begin with the burger restaurant menu or the sandwich restaurant menu in Week 1; the two restaurants then alternate weekly, so that each participant sees the first restaurant in Weeks 1, 3, 5 and 7 and the other restaurant in Weeks 2, 4 and 6. |
A control label consisting of a QR code is applied to the main items on both restaurant menus in Weeks 2-7. The label carries no environmental information. |
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Kísérleti: Environmental Harm Labels
Participants order one lunch per week for seven weeks from two alternating fast-food restaurant menus. The Week 1 menu is unlabeled. In Weeks 2-7, traffic-light style environmental harm labels are applied to all main items on the restaurant menus. Participants in this arm are randomized in equal numbers to begin with the burger restaurant menu or the sandwich restaurant menu in Week 1; the two restaurants then alternate weekly, so that each participant sees the first restaurant in Weeks 1, 3, 5 and 7 and the other restaurant in Weeks 2, 4 and 6. |
Traffic-light style environmental harm labels are applied to the main items on both restaurant menus in Weeks 2-7. Each label conveys the environmental harm of the item, defined for participants as how much water and land are required to produce it. Harm levels are assigned from ingredient-level land use and water use factors applied to the ingredients of each menu item. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Modified Nutrient Profile Index score of weekly fast-food meal orders
Időkeret: Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
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The primary outcome measure will be the healthfulness of the fast-food meal selections, measured with a modified Nutrient Profile Index (NPI) score. NPI scores are based on the United Kingdom (UK) Ofcom Nutrient Profiling Model, which is used to score individual foods in the UK to determine which ones can be marketed to children. The NPI is a 0 to 100-point score for foods; a score of >=64 is considered healthy. Higher score better. NPI awards points from nutrients to encourage (e.g., fiber, protein) and nutrients of concern (e.g., sodium, sugar) per 100 grams. The investigators will generate a modified NPI score to evaluate the healthfulness of full meals comprised of multiple food items. This measure will be determined by calculating the weighted mean NPI score of all food items selected per meal, with each item's NPI score weighted by its proportionate contribution of mass in grams to the total mass of the meal. Beverages are excluded from the meal score and assessed separately. |
Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Nutrient Profile Index score of the weekly fast-food main item
Időkeret: Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
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The healthfulness of the fast-food main item selections, measured with a Nutrient Profile Index (NPI) score. NPI scores are based on the United Kingdom (UK) Ofcom Nutrient Profiling Model, which is used to score individual foods in the UK to determine which ones can be marketed to children. The NPI is a 0 to 100-point score for foods; a score of >=64 is considered healthy. Higher score better. |
Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
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Total energy of the weekly meal order
Időkeret: Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
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Total calories of each weekly meal order, summed across all items ordered, derived from the nutrient composition of the items selected. |
Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
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Protein content of the weekly meal order
Időkeret: Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
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Protein content of each weekly meal order, in grams, summed across all items ordered and derived from the nutrient composition of the items selected. |
Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
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Fiber content of the weekly meal order
Időkeret: Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
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Fiber content of each weekly meal order, in grams, summed across all items ordered and derived from the nutrient composition of the items selected. |
Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
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Saturated fat content of the weekly meal order
Időkeret: Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
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Saturated fat content of each weekly meal order, in grams, summed across all items ordered and derived from the nutrient composition of the items selected. |
Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
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Sugar content of the weekly meal order
Időkeret: Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
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Sugar content of each weekly meal order, in grams, summed across all items ordered and derived from the nutrient composition of the items selected. |
Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
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Sodium content of the weekly meal order
Időkeret: Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
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Sodium content of each weekly meal order, in milligrams, summed across all items ordered and derived from the nutrient composition of the items selected. |
Once weekly for seven weeks (Week 1 unlabeled baseline; Weeks 2-7 labeled)
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Együttműködők és nyomozók
Együttműködők
Nyomozók
- Kutatásvezető: Julia Wolfson, PhD, MPP, Johns Hopkins Bloomberg School of Public Health
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- IRB00036491-1
- R01DK139327 (Az Egyesült Államok NIH támogatása/szerződése)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
Investigators will share individual-level data without identifiers with co-investigators and members of the study team who will participate in data analysis. After findings are published, per the Data Management and Sharing Plan, investigators will upload de-identified datasets to the Open Science Framework (OSF) repository, a free open platform to share research. Stored data on OSF will have a unique, persistent URL for citing and sharing.
IPD megosztási időkeret
After the study team has published results, investigators will make data and other documents available. There is no end date for availability.
IPD-megosztási hozzáférési feltételek
Data and supporting documentation will be publicly available on the Open Science Framework website.
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ICF
- ANALYTIC_CODE
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