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

21 février 2014 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

31

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19141
        • Albert Einstein Healthcare Network

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Immediate intervention
Group begins the 4 week Pre-Ordering Program intervention immediately following a 4-wk baseline period.
Autre: 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.
Autre: Wait-listed control
Group begins the 4 week Pre-Ordering Program intervention following an 8-wk baseline period.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Total number of calories
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Total number of calories from fat
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Albert Einstein Healthcare Network

Collaborateurs

Aramark Healthcare

Les enquêteurs

  • Chercheur principal: Etienne J Phipps, PhD, Albert Einstein Healthcare Network

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2012

Achèvement primaire (Réel)

1 décembre 2012

Achèvement de l'étude (Réel)

1 décembre 2013

Dates d'inscription aux études

Première soumission

30 juillet 2012

Première soumission répondant aux critères de contrôle qualité

27 août 2012

Première publication (Estimation)

29 août 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

24 février 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 février 2014

Dernière vérification

1 août 2012

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • HN 4262

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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