What to Eat for Lunch? A Pilot Study to Improve Healthier Eating at Work
This pilot study will test the feasibility and potential effectiveness of a novel approach to improve food choices by employees about what to eat for lunch. The intervention involves the testing of an on-line pre-ordering food program with nutritional information linked to a hospital cafeteria. In this study, the investigators use positive reinforcement of feedback and price discounts during the intervention phase, and then withdraw those components in order to assess the potential for changes to be retained after the study is over.
The study draws on principles from the field of behavioral economics and behavioral change. The investigators test the effectiveness of the intervention with 30 employees (study participants) who are overweight or obese. Based on a recent screening of over 5600 Einstein employees, 66% of those screened were identified as either overweight or obese. There are 3 phases to the trial: baseline (P1), 4 week intervention, (P2) and tapering (intervention without reinforcement) (P3). Participants are randomized to one of two groups (intervention and wait-listed controls).
Our primary hypotheses are that:
- Participants will purchase lunches with fewer calories during the intervention compared to baseline.
- Participants will purchases lunches with fewer calories in the tapering phase compared to baseline.
Secondary hypotheses include that, compared with baseline, participants will order lunches with less fat. Changes in participant weight based on self selected goals, and in a measure of mindful eating will also be investigated. The investigators expect that participant adherence will be associated with improved outcomes compared to those who are less adherent.
調査の概要
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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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19141
- Albert Einstein Healthcare Network
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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
受講資格のある性別
説明
Inclusion Criteria:
- Interested in improving their food choices as it relates to healthier eating and weight loss
- Adult employee at large, urban hospital in Philadelphia at which study is being conducted
- Eats at least 4 lunch meals a week at study cafeteria
- BMI greater than or equal to 25.0 (based on standard classification).
- Willingness to allow researchers to collect data about their lunch purchases
- Willingness to "swipe" their employee card for lunch purchases during the study
- Access to a computer at work
- Capable of providing informed consent
- Has a way of being contacted by telephone, email, fax, or receiving a text message
Exclusion Criteria:
- Planning to terminate hospital employment within the next 4 months
- Individuals unable to consent
- Individuals who are not yet adults
- Employees who are pregnant
- Employees with hypertension, dyslipidemia or coronary artery disease whose medical therapy has changed in the past 3 months.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
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：Immediate intervention
Group begins the 4 week Pre-Ordering Program intervention immediately following a 4-wk baseline period.
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During the 4 week intervention phase, participants use the pre-ordering program, receive a novel, "smart receipt" upon checkout that will detail the caloric and fat content of what they ordered, and receive price discounts for select low calorie and low fat items.
The pre-ordering system is designed to provide the opportunity for the individual to see what is available along with nutritional information and to make a selection ahead of time.
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他の：Wait-listed control
Group begins the 4 week Pre-Ordering Program intervention following an 8-wk baseline period.
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During the 4 week intervention phase, participants use the pre-ordering program, receive a novel, "smart receipt" upon checkout that will detail the caloric and fat content of what they ordered, and receive price discounts for select low calorie and low fat items.
The pre-ordering system is designed to provide the opportunity for the individual to see what is available along with nutritional information and to make a selection ahead of time.
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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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Total number of calories
時間枠：Participants are followed for a minimum of 12 weeks and the total calories from their lunchtime meals are recorded daily.
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The average number of calories (Kcal) purchased for lunch.
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Participants are followed for a minimum of 12 weeks and the total calories from their lunchtime meals are recorded daily.
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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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Total number of calories from fat
時間枠：Participants are followed for a minimum of 12 weeks and the total calories from fat in their lunchtime meals are recorded daily.
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The average number of calories from fat (g) purchased for lunch.
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Participants are followed for a minimum of 12 weeks and the total calories from fat in their lunchtime meals are recorded daily.
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Participant adherence
時間枠：Participants are followed for a minimum of 12 weeks
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Participant adherence is measured by the participants' self-report of engagement in the intervention activities, objective measure of using the pre-ordering system to place lunch purchases, objective measure of the purchase of lunch in the study cafeteria, completion of study materials, and participant report of barriers to engagement in the study.
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Participants are followed for a minimum of 12 weeks
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Participant body weight (kg)
時間枠：Recorded at the time of recruitment into the study and again following the 8 week intervention
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The average percent change in body weight from baseline to end of the intervention.
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Recorded at the time of recruitment into the study and again following the 8 week intervention
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Hemoglobin A1c (HbA1c)
時間枠：Measured at the time of recruitment into the study and again following the 8 week intervention
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The average change in participant Hemoglobin A1c (HbA1c, mmol/mol) will be reported in order to assess change in average plasma glucose concentrations.
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Measured at the time of recruitment into the study and again following the 8 week intervention
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Cholesterol subfractions
時間枠：Measured at the time of recruitment into the study and again following the 8 week intervention
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The average change in participant cholesterol subfractions (g/mL) will be reported in order to evaluate change in risk of coronary heart disease.
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Measured at the time of recruitment into the study and again following the 8 week intervention
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Blood pressure (mmHg)
時間枠：Measured at the time of recruitment into the study and again following the 8 week intervention
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The average change in blood pleasure (mmHg) will be reported.
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Measured at the time of recruitment into the study and again following the 8 week intervention
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Mindful eating score on 28-item self-report measure
時間枠：Recorded at the time of recruitment into the study and again following the 8 week intervention
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The average change in mindfulness when eating will be reported.
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Recorded at the time of recruitment into the study and again following the 8 week intervention
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協力者と研究者
捜査官
- 主任研究者：Etienne J Phipps, PhD、Albert Einstein Healthcare Network
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
キーワード
その他の研究ID番号
- HN 4262
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。
Pre-ordering programの臨床試験
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University of BarcelonaLaerdal Medical招待による登録
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Derya Öztürk ÖzenHacettepe University; Saglik Bilimleri Universitesi完了
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Children's Health積極的、募集していない