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

21 febbraio 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

31

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19141
        • Albert Einstein Healthcare Network

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Immediate intervention
Group begins the 4 week Pre-Ordering Program intervention immediately following a 4-wk baseline period.
Altro: 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.
Altro: Wait-listed control
Group begins the 4 week Pre-Ordering Program intervention following an 8-wk baseline period.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total number of calories
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total number of calories from fat
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Albert Einstein Healthcare Network

Collaboratori

Aramark Healthcare

Investigatori

  • Investigatore principale: Etienne J Phipps, PhD, Albert Einstein Healthcare Network

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2012

Completamento primario (Effettivo)

1 dicembre 2012

Completamento dello studio (Effettivo)

1 dicembre 2013

Date di iscrizione allo studio

Primo inviato

30 luglio 2012

Primo inviato che soddisfa i criteri di controllo qualità

27 agosto 2012

Primo Inserito (Stima)

29 agosto 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

24 febbraio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 febbraio 2014

Ultimo verificato

1 agosto 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • HN 4262

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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