レストランでの子供たちの健康的な食事の促進
調査の概要
詳細な説明
レストランは、多くの家族にとって規範的な食事の場です。 レストランでの食事は、家庭で調理するよりもカロリーが高く、栄養価が低い傾向があります。 レストランで子供向けの食品を選択することは、食事の質を改善し、過剰なエネルギー摂取を減らし、健康的な習慣を形成する可能性を秘めています。 この研究の目的は、より健康的な子供の食事オプションをより魅力的で、選択しやすいものにすることです.
周辺の国勢調査地区の収入レベルに基づいて、6 か所のクイックサービス レストランがペアになります。 各ペアからの場所は、各研究グループ (介入、対照) に無作為化されます。 採用とデータ収集は、3 つのコホートで実施されます。 募集後、家族はいつものように注文して食事をするよう求められます。 参加しているすべての家族は、子供の注文、摂取量、および人口統計の測定を完了します。 その後、家族はランチョン マットと常連カードを受け取ります。 介入レストランの家族は、より健康的な注目の子供向けの食事を宣伝するプレースマットを受け取ります. これらの家族は、定期ダイナー カードも受け取ります。このカードは、注目のヘルシーなキッズ ミールの 1 つを 6 回購入した後、所定の引き換え期間中に選択した無料のキッズ ミールの対象となります。 対照グループには、ベースライン データの収集に続いて一般的なプレースマットが提供され、家族には子供の食事に使用できる頻繁なダイナー カードも提供されます。 コホートごとに約 2 か月続くその後の暴露期間中、家族は週に 1 度、募集されたレストランの場所に戻ります。 レストランの入り口にはランチョンマットが用意されており、対応する看板がレストランに表示されます。 介入レストランでは、宣伝された食事と、デザートの代わりにおもちゃを選択するオプションを宣伝する看板が表示されます。 参加しているお子様は、この期間中にフリークエント ダイナー カードを使用して、その後の引き換え期間中に無料の食事を獲得できます。 家族はまた、レストランの利用状況を監視するために、週に 1 回簡単なオンライン調査に回答するよう求められます。 各レストランで、研究スタッフは、参加している家族とサーバーの相互作用のサブサンプルの観察を行います。 最後に、事後評価は、コホートごとに約 3 か月続く所定の償還期間中に完了します。 この間、レストランではプレースマットとサイネージを引き続きご利用いただけます。 スタディ スタッフはよく利用するダイナー カードを収集し、家族に通常どおりに注文して食事をし、食べ物や残り物を捨てないように依頼します。 この期間中、ご家族は獲得した無料のキッズミールを引き換えることができます。 家族が食事を終えると、研究スタッフがテーブルに近づき、注文、食事の見方、および摂取量を評価する研究措置を管理します. 最後に、家族は、評価後のオンライン食事リコール (ASA24) を完了するように求められます。
この研究の具体的な目的は、(1) より健康的な子供の食事介入が子供の食事の注文に及ぼす影響をテストすること、および (2) より健康的な子供の食事介入が子供の食事摂取量に及ぼす影響をテストすることです。 (1a) 介入レストランの子供たちは対照群よりも、ポストテストで宣伝されたより健康的な子供向けの食事を選択する可能性が高く、(1b) 介入グループの子供はより少ないカロリーとデザートを注文し、飽和度が低いという仮説が立てられています。 (1c) 調査期間中の販売データに基づいて、介入レストランで注文された子供向け食事のうち、宣伝されたより健康的な食事が占める割合が、対照と比べて高くなります。(2)対照群と比較して、介入群の子供たちは、テスト後のレストランで消費するカロリーと飽和脂肪、ナトリウム、砂糖が少なくなります。
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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New York
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Buffalo、New York、アメリカ、14214
- State University of New York at Buffalo
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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
説明
包含基準:
- 流暢な英語(保護者と子供)
- 18歳以上(保護者)
- 4歳~8歳(こども)
- 少なくとも週に 1 回はレストランの料理を食べる (子供)
- -研究への安全な参加を妨げるアレルギーがない(子供)
- 採用・ベースライン査定時のレストランでの食事
- この研究のパイロット段階には参加しなかった
除外基準:
- 18歳未満(保護者)
- 4歳から8歳までの子供がいない
- 流暢に英語を話せない (親/保護者 & 子供)
- 少なくとも週に 1 回はレストランの料理を食べない (子供)
- 研究への安全な参加を妨げる食物アレルギーがある(子供)
- 募集/ベースライン時にレストランで食事をしていない
- この研究のパイロット段階に参加し、同じレストランチェーンでより健康的な食事オプションの可能性のある味のテストを行いました
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 |
|---|---|
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実験的:より健康的な食事を促進するプレースマットと常連客カード
参加者は、より健康的な子供向けの食事を宣伝するプレースマットと、子供の食事トークンをデザートの代わりにおもちゃと引き換える機会を受け取ります。
また、ご家族はフリークエント ダイナー カードも受け取ります。このカードは、注目のヘルシーなキッズミールの 1 つを 6 回購入した後、所定の引き換え期間中に選択した無料のキッズミールの対象となります。
対応する看板がレストランに表示されます。
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参加者は、より健康的な子供向けの食事を宣伝するプレースマットと、子供の食事トークンをデザートの代わりにおもちゃと引き換える機会を受け取ります。
また、ご家族はフリークエント ダイナー カードも受け取ります。このカードは、注目のヘルシーなキッズミールの 1 つを 6 回購入した後、所定の引き換え期間中に選択した無料のキッズミールの対象となります。
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アクティブコンパレータ:Generic placemats and frequent diner cards
Participants will receive generic placemats listing all of the restaurant's kids' meals.
Families will also receive a generic frequent diner card, which after purchasing (any) kids' meals across 6 occasions, makes them eligible for a free kids' meal of their choice during a predetermined redemption period.
Corresponding signage will be displayed in the restaurant.
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Participants receive generic placemats and frequent diner cards that do not promote any specific kids' meal.
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介入なし:Pilot phase
Pilot (taste testing) phase completed before the trial to finalize the healthier meals that would be promoted in the intervention.
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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 |
|---|---|---|
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Meal Type Ordered for Child in Restaurant
時間枠:Post-test (about 4 months after recruitment)
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Whether a healthier children's meal or other children's meal was ordered (bundled meal including promoted healthy main dish, healthy side, and healthy beverage).
Counts reported indicate the number of children who ordered a healthy bundled meal.
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Post-test (about 4 months after recruitment)
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Change in Meal Type Ordered for Child in Restaurant
時間枠:Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
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Whether a healthier children's meal or other children's meal was ordered.
Counts reflect the raw change in number of participants ordering the bundled healthy meal from baseline to post-test, by group.
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Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
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Total Calories Ordered for Child in Restaurant
時間枠:Post-test (about 4 months after recruitment)
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Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total calories ordered
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Post-test (about 4 months after recruitment)
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Change in Total Calories Ordered for Child in Restaurant
時間枠:Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
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Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total calories ordered
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Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
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Total Saturated Fat Ordered for Child in Restaurant
時間枠:Post-test (about 4 months after recruitment)
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Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total saturated fat ordered.
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Post-test (about 4 months after recruitment)
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Change in Total Saturated Fat Ordered for Child in Restaurant
時間枠:Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
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Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total saturated fat ordered.
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Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
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Total Sugar Ordered for Child in Restaurant
時間枠:Post-test (about 4 months after recruitment)
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Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total sugar ordered.
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Post-test (about 4 months after recruitment)
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Change in Total Sugar Ordered for Child in Restaurant
時間枠:Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
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Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total sugar ordered.
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Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
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Total Sodium Ordered for Child in Restaurant
時間枠:Post-test (about 4 months after recruitment)
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Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total sodium ordered.
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Post-test (about 4 months after recruitment)
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Change in Total Sodium Ordered for Child in Restaurant
時間枠:Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
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Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total sodium ordered.
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Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
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Dessert Ordered for Child in Restaurant
時間枠:Post-test (about 4 months after recruitment)
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Whether or not a dessert was ordered.
Counts below reflect the number of children ordering a dessert at post-test.
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Post-test (about 4 months after recruitment)
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Change in Dessert Ordered for Child in Restaurant
時間枠:Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
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Whether or not a dessert was ordered.
Numbers below reflect change in likelihood of ordering dessert from baseline to post-test in the context of the generalized linear mixed model with all time points (baseline, midpoints 1-9, post-test).
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Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Calories Consumed at Restaurant by Child in Restaurant
時間枠:Post-test (about 4 months after recruitment)
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Children's dietary intake will be measured using plate waste methodology.
Grams consumed will be converted to percentages using total grams from pre-weights, and these percentages will be multiplied by the total calories in the full item to calculate calories consumed.
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Post-test (about 4 months after recruitment)
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Changes in Calories Consumed at Restaurant by Child in Restaurant
時間枠:Baseline, post-test (about 4 months after recruitment)
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Children's dietary intake will be measured using plate waste methodology.
Grams consumed will be converted to percentages using total grams from pre-weights, and these percentages will be multiplied by the total calories in the full item to calculate calories consumed.
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Baseline, post-test (about 4 months after recruitment)
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Saturated Fat Consumed at Restaurant by Child in Restaurant
時間枠:Post-test (about 4 months after recruitment)
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Children's dietary intake will be measured using plate waste methodology.
Grams consumed will be converted to percentages using total grams from pre-weights, and these percentages will be multiplied by the total saturated fat in the full item to calculate saturated fat consumed.
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Post-test (about 4 months after recruitment)
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Changes in Saturated Fat Consumed at Restaurant by Child in Restaurant
時間枠:Baseline, post-test (about 4 months after recruitment)
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Children's dietary intake will be measured using plate waste methodology.
Grams consumed will be converted to percentages using total grams from pre-weights, and these percentages will be multiplied by the total saturated fat in the full item to calculate saturated fat consumed.
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Baseline, post-test (about 4 months after recruitment)
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Sugar Consumed at Restaurant by Child in Restaurant
時間枠:Post-test (about 4 months after recruitment)
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Children's dietary intake will be measured using plate waste methodology.
Grams consumed will be converted to percentages using total grams from pre-weights, and these percentages will be multiplied by the total sugar in the full item to calculate sugar consumed.
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Post-test (about 4 months after recruitment)
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Changes in Sugar Consumed at Restaurant by Child in Restaurant
時間枠:Baseline, post-test (about 4 months after recruitment)
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Children's dietary intake will be measured using plate waste methodology.
Grams consumed will be converted to percentages using total grams from pre-weights, and these percentages will be multiplied by the total sugar in the full item to calculate sugar consumed.
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Baseline, post-test (about 4 months after recruitment)
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Sodium Consumed at Restaurant by Child in Restaurant
時間枠:Post-test (about 4 months after recruitment)
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Children's dietary intake will be measured using plate waste methodology.
Grams consumed will be converted to percentages using total grams from pre-weights, and these percentages will be multiplied by the total sodium in the full item to calculate sodium consumed.
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Post-test (about 4 months after recruitment)
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Changes in Sodium Consumed at Restaurant by Child in Restaurant
時間枠:Baseline, post-test (about 4 months after recruitment)
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Children's dietary intake will be measured using plate waste methodology.
Grams consumed will be converted to percentages using total grams from pre-weights, and these percentages will be multiplied by the total sodium in the full item to calculate sodium consumed.
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Baseline, post-test (about 4 months after recruitment)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Healthier Children's Meals Ordered at Aggregate Level
時間枠:Through study completion, an average of 3 years
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Aggregated sales data from the restaurant will be collected to monitor sales of healthier kids' meals across all patrons in Anderson's restaurants by study group during the study period.
Children's orders were studied in aggregate; thus individual study participants were not studied here.
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Through study completion, an average of 3 years
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Healthier Children's Meals Ordered at Aggregate Level
時間枠:Exposure period (lasting from about 2 to about 4 months after participant recruitment)
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Aggregated sales data from the restaurant will be collected to monitor sales of healthier kids' meals across all patrons in Anderson's restaurants by study group during the exposure period.
Given that the intervention experienced by the general population (as opposed to study participants) is the same during midpoints and post-test, note that here exposure refers to midpoints plus post-test as described in a priori published protocol paper.
Children's orders were studied in aggregate; thus individual study participants were not studied here.
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Exposure period (lasting from about 2 to about 4 months after participant recruitment)
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Healthier Children's Meals Ordered at Aggregate Level
時間枠:Baseline
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Aggregated sales data from the restaurant will be collected to monitor sales of healthier kids' meals across all patrons in Anderson's restaurants by study group during the baseline period.
Only aggregate data were recorded here; no data for individual child participants are available.
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Baseline
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Changes in Kids' Meals Ordered at Aggregate Level
時間枠:1 and 2 years prior to study exposure period
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Aggregated sales data from the restaurant will be collected to monitor sales of kids' meals across all patrons in Anderson's restaurants during time points parallel to the exposure period, 1 and 2 years prior to the study (for historical comparison).
2 years was added after original study planning but before study completion, given that 1 year prior to the study was 2020, a year impacted by the COVID-19 pandemic.
Only aggregate data were recorded here (no individual participant data).
Values from the two time points (1 year prior and 2 years prior) are summed.
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1 and 2 years prior to study exposure period
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Total Daily Calories Consumed by Child
時間枠:Post-test (about 4 months after recruitment)
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Parents will report children's daily dietary intake using the Automated Self-administered 24-hour Dietary Assessment Tool (ASA24) the day after the in-restaurant part of the post-test assessment.
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Post-test (about 4 months after recruitment)
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Total Saturated Fat Consumed by Child
時間枠:Post-test (about 4 months after recruitment)
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Parents will report children's daily dietary intake using the Automated Self-administered 24-hour Dietary Assessment Tool (ASA24) the day after the in-restaurant part of the post-test assessment.
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Post-test (about 4 months after recruitment)
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Total Sugar Consumed by Child
時間枠:Post-test (about 4 months after recruitment)
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Parents will report children's daily dietary intake using the Automated Self-administered 24-hour Dietary Assessment Tool (ASA24) the day after the in-restaurant part of the post-test assessment.
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Post-test (about 4 months after recruitment)
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Total Sodium Consumed by Child
時間枠:Post-test (about 4 months after recruitment)
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Parents will report children's daily dietary intake using the Automated Self-administered 24-hour Dietary Assessment Tool (ASA24) the day after the in-restaurant part of the post-test assessment.
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Post-test (about 4 months after recruitment)
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協力者と研究者
捜査官
- 主任研究者:Stephanie Anzman-Frasca, PhD、University at Buffalo
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
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。