What to Eat for Lunch? A Pilot Study to Improve Healthier Eating at Work
21. februar 2014 oppdatert 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
31
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19141
- Albert Einstein Healthcare Network
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Immediate intervention
Group begins the 4 week Pre-Ordering Program intervention immediately following a 4-wk baseline period.
|
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.
|
|
Annen: Wait-listed control
Group begins the 4 week Pre-Ordering Program intervention following an 8-wk baseline period.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total number of calories
Tidsramme: Participants are followed for a minimum of 12 weeks and the total calories from their lunchtime meals are recorded daily.
|
The average number of calories (Kcal) purchased for lunch.
|
Participants are followed for a minimum of 12 weeks and the total calories from their lunchtime meals are recorded daily.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total number of calories from fat
Tidsramme: Participants are followed for a minimum of 12 weeks and the total calories from fat in their lunchtime meals are recorded daily.
|
The average number of calories from fat (g) purchased for lunch.
|
Participants are followed for a minimum of 12 weeks and the total calories from fat in their lunchtime meals are recorded daily.
|
|
Participant adherence
Tidsramme: Participants are followed for a minimum of 12 weeks
|
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.
|
Participants are followed for a minimum of 12 weeks
|
|
Participant body weight (kg)
Tidsramme: Recorded at the time of recruitment into the study and again following the 8 week intervention
|
The average percent change in body weight from baseline to end of the intervention.
|
Recorded at the time of recruitment into the study and again following the 8 week intervention
|
|
Hemoglobin A1c (HbA1c)
Tidsramme: Measured at the time of recruitment into the study and again following the 8 week intervention
|
The average change in participant Hemoglobin A1c (HbA1c, mmol/mol) will be reported in order to assess change in average plasma glucose concentrations.
|
Measured at the time of recruitment into the study and again following the 8 week intervention
|
|
Cholesterol subfractions
Tidsramme: Measured at the time of recruitment into the study and again following the 8 week intervention
|
The average change in participant cholesterol subfractions (g/mL) will be reported in order to evaluate change in risk of coronary heart disease.
|
Measured at the time of recruitment into the study and again following the 8 week intervention
|
|
Blood pressure (mmHg)
Tidsramme: Measured at the time of recruitment into the study and again following the 8 week intervention
|
The average change in blood pleasure (mmHg) will be reported.
|
Measured at the time of recruitment into the study and again following the 8 week intervention
|
|
Mindful eating score on 28-item self-report measure
Tidsramme: Recorded at the time of recruitment into the study and again following the 8 week intervention
|
The average change in mindfulness when eating will be reported.
|
Recorded at the time of recruitment into the study and again following the 8 week intervention
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Etienne J Phipps, PhD, Albert Einstein Healthcare Network
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2012
Primær fullføring (Faktiske)
1. desember 2012
Studiet fullført (Faktiske)
1. desember 2013
Datoer for studieregistrering
Først innsendt
30. juli 2012
Først innsendt som oppfylte QC-kriteriene
27. august 2012
Først lagt ut (Anslag)
29. august 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
24. februar 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. februar 2014
Sist bekreftet
1. august 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- HN 4262
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .