What to Eat for Lunch? A Pilot Study to Improve Healthier Eating at Work
21 februari 2014 uppdaterad av: Etienne Phipps, Albert Einstein Healthcare Network
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.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
31
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19141
- Albert Einstein Healthcare Network
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Övrig: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Total number of calories
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Total number of calories from fat
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Etienne J Phipps, PhD, Albert Einstein Healthcare Network
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2012
Primärt slutförande (Faktisk)
1 december 2012
Avslutad studie (Faktisk)
1 december 2013
Studieregistreringsdatum
Först inskickad
30 juli 2012
Först inskickad som uppfyllde QC-kriterierna
27 augusti 2012
Första postat (Uppskatta)
29 augusti 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
24 februari 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 februari 2014
Senast verifierad
1 augusti 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- HN 4262
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .