What to Eat for Lunch? A Pilot Study to Improve Healthier Eating at Work
21 februari 2014 bijgewerkt door: 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.
Studie Overzicht
Studietype
Ingrijpend
Inschrijving (Werkelijk)
31
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19141
- Albert Einstein Healthcare Network
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Ander: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Total number of calories
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Total number of calories from fat
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Etienne J Phipps, PhD, Albert Einstein Healthcare Network
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2012
Primaire voltooiing (Werkelijk)
1 december 2012
Studie voltooiing (Werkelijk)
1 december 2013
Studieregistratiedata
Eerst ingediend
30 juli 2012
Eerst ingediend dat voldeed aan de QC-criteria
27 augustus 2012
Eerst geplaatst (Schatting)
29 augustus 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
24 februari 2014
Laatste update ingediend die voldeed aan QC-criteria
21 februari 2014
Laatst geverifieerd
1 augustus 2012
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- HN 4262
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