Environmental Harm Menu Labels and Overall Dietary Quality (MENU)
Longitudinal Trial Evaluating the Influence of Environmental Harm Menu Labels on Overall Dietary Quality
The primary objective of this study is to evaluate whether repeated exposure to environmental harm menu labels on fast-food restaurant menus changes overall dietary quality. 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. The outcome is the change in overall dietary quality from baseline to endline, assessed with 24-hour dietary recalls before and after the seven-week ordering period.
調査の概要
状態
条件
詳細な説明
Fast-food restaurants, where over 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 assesses the change in overall dietary intake after seven weeks of repeated exposure to environmental harm labels on fast-food menus, in a real-world setting in which participants receive the foods chosen foods.
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 their 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.
To assess changes in overall dietary quality, participants will complete two 24-hour dietary recalls at baseline, prior to the seven-week ordering period, and two at follow-up, administered by the Johns Hopkins Institute for Clinical and Translational Research (ICTR) Nutrition Core. Participants will also 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 change in overall dietary quality from baseline to endline, measured with the Healthy Eating Index-2020. Secondary outcomes include changes to the 13 Health Eating Index Score sub-components, and changes in beef consumption, total energy intake, fiber intake, ultra-processed food intake, and dietary quality at different eating occasions and locations. All study activities are conducted remotely; there are no in-person study visits.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Nina Carr, MPH, MBA
- 電話番号:240-405-2823
- メール:ncarr6@jhu.edu
研究連絡先のバックアップ
- 名前:Julia Wolfson, PhD, MPP
- 電話番号:213-359-2915
- メール:jwolfso7@jhu.edu
研究場所
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21205
- 募集
- Johns Hopkins Bloomberg School of Public Health
-
コンタクト:
- Nina Carr, MPH, MBA
- 電話番号:240-405-2823
- メール:ncarr6@jhu.edu
-
主任研究者:
- Julia Wolfson, PhD, MPP
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター: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 their 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. |
|
実験的: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 their 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. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in overall dietary quality (Healthy Eating Index-2020)
時間枠:Baseline (Week 0, prior to the ordering period) and endline (Week 8, after the seven-week ordering period)
|
Dietary quality is measured with the Healthy Eating Index-2020 (HEI-2020), calculated from mean intake across two 24-hour dietary recalls administered at each timepoint by trained staff of the Johns Hopkins ICTR Nutrition Core. HEI-2020 is a composite measure of dietary quality scored from 0 to 100, based on 13 components: nine adequacy components (e.g., whole grains, total vegetables, seafood and plant proteins) and four moderation components (e.g., refined grains, sodium, added sugars). A higher score indicates better diet quality and closer alignment with the 2020-2025 Dietary Guidelines for Americans. |
Baseline (Week 0, prior to the ordering period) and endline (Week 8, after the seven-week ordering period)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in HEI-2020 sub-component scores (Adequacy and Moderation)
時間枠:Baseline (Week 0) and endline (Week 8)
|
Adequacy scores range from 0-5 (total fruits, whole fruits, total vegetables, greens and beans, total protein foods, seafood and plant proteins). Moderation scores range from 0-10 (whole grains, dairy, fatty acids, refined grains, sodium, added sugars, saturated fats). Higher scores indicate healthier intake (higher intake for adequacy components and lower intake for moderation components). |
Baseline (Week 0) and endline (Week 8)
|
|
Change in intake of total fruits (HEI sub-component)
時間枠:Baseline (Week 0) and endline (Week 8)
|
Total fruit (including 100% fruit juice) intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
Baseline (Week 0) and endline (Week 8)
|
|
Change in intake of whole fruits (HEI sub-component)
時間枠:Baseline (Week 0) and endline (Week 8)
|
Total whole fruit (excluding 100% fruit juice) intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
Baseline (Week 0) and endline (Week 8)
|
|
Change in intake of total vegetables (HEI sub-component)
時間枠:Baseline (Week 0) and endline (Week 8)
|
Total vegetable intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
Baseline (Week 0) and endline (Week 8)
|
|
Change in intake of greens and beans (HEI sub-component)
時間枠:Baseline (Week 0) and endline (Week 8)
|
Total intake of greens and beans in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
Baseline (Week 0) and endline (Week 8)
|
|
Change in intake of whole grains (HEI sub-component)
時間枠:Baseline (Week 0) and endline (Week 8)
|
Total whole grain intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
Baseline (Week 0) and endline (Week 8)
|
|
Change in intake of dairy (HEI sub-component)
時間枠:Baseline (Week 0) and endline (Week 8)
|
Total dairy intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
Baseline (Week 0) and endline (Week 8)
|
|
Change in intake of total protein foods (HEI sub-component)
時間枠:Baseline (Week 0) and endline (Week 8)
|
Total protein food (including legumes) intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
Baseline (Week 0) and endline (Week 8)
|
|
Change in intake of seafood and plant proteins (HEI sub-component)
時間枠:Baseline (Week 0) and endline (Week 8)
|
Total seafood and plant protein (including nuts, seeds, soy products, legumes) intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each time point. |
Baseline (Week 0) and endline (Week 8)
|
|
Change in intake of fatty acids (HEI sub-component)
時間枠:Baseline (Week 0) and endline (Week 8)
|
Ratio of fatty acids (PUFA + MUFA)/ SFA, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
Baseline (Week 0) and endline (Week 8)
|
|
Change in intake of refined grains (HEI sub-component)
時間枠:Baseline (Week 0) and endline (Week 8)
|
Total refined grain intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
Baseline (Week 0) and endline (Week 8)
|
|
Change in intake of sodium (HEI sub-component)
時間枠:Baseline (Week 0) and endline (Week 8)
|
Total sodium intake in milligrams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
Baseline (Week 0) and endline (Week 8)
|
|
Change in intake of added sugar (HEI sub-component)
時間枠:Baseline (Week 0) and endline (Week 8)
|
Total added sugar intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
Baseline (Week 0) and endline (Week 8)
|
|
Change in intake of saturated fat (HEI sub-component)
時間枠:Baseline (Week 0) and endline (Week 8)
|
Total saturated fat intake in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
Baseline (Week 0) and endline (Week 8)
|
|
Change in beef consumption
時間枠:Baseline (Week 0) and endline (Week 8)
|
Beef consumption in grams per day, derived from the mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. A decrease indicates reduced beef consumption. |
Baseline (Week 0) and endline (Week 8)
|
|
Change in total energy intake
時間枠:Baseline (Week 0) and endline (Week 8)
|
Total energy intake in kilocalories per day, derived from mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
Baseline (Week 0) and endline (Week 8)
|
|
Change in fiber intake
時間枠:Baseline (Week 0) and endline (Week 8)
|
Fiber intake in grams per day, derived from mean intake across the two 24-hour dietary recalls at each timepoint. The outcome is the difference between endline and baseline. |
Baseline (Week 0) and endline (Week 8)
|
協力者と研究者
協力者
捜査官
- 主任研究者:Julia Wolfson, PhD, MPP、Johns Hopkins Bloomberg School of Public Health
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB00036491-2
- R01DK139327 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The investigators will share individual-level data without identifiers with co-investigators and members of the study team who will participate in data analysis. After the investigators have published the findings, per the Data Management and Sharing Plan, the 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 共有時間枠
After the study team has published results, the investigators will make data and other documents available. There is no end date for availability.
IPD 共有アクセス基準
Data and supporting documentation will be publicly available on the Open Science Framework website.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。