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What to Eat for Lunch? A Pilot Study to Improve Healthier Eating at Work

21. februar 2014 opdateret af: 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:

  1. Participants will purchase lunches with fewer calories during the intervention compared to baseline.
  2. 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19141
        • Albert Einstein Healthcare Network

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Immediate intervention
Group begins the 4 week Pre-Ordering Program intervention immediately following a 4-wk baseline period.
Andet: Pre-ordering program
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.
Andet: Wait-listed control
Group begins the 4 week Pre-Ordering Program intervention following an 8-wk baseline period.
Andet: Pre-ordering program
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Albert Einstein Healthcare Network

Samarbejdspartnere

Aramark Healthcare

Efterforskere

  • Ledende efterforsker: Etienne J Phipps, PhD, Albert Einstein Healthcare Network

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2012

Primær færdiggørelse (Faktiske)

1. december 2012

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

30. juli 2012

Først indsendt, der opfyldte QC-kriterier

27. august 2012

Først opslået (Skøn)

29. august 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. februar 2014

Sidst verificeret

1. august 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • HN 4262

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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