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

February 21, 2014 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Healthcare Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate intervention
Group begins the 4 week Pre-Ordering Program intervention immediately following a 4-wk baseline period.
Other: 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.
Other: Wait-listed control
Group begins the 4 week Pre-Ordering Program intervention following an 8-wk baseline period.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of calories
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of calories from fat
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein Healthcare Network

Collaborators

Aramark Healthcare

Investigators

  • Principal Investigator: Etienne J Phipps, PhD, Albert Einstein Healthcare Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 30, 2012

First Submitted That Met QC Criteria

August 27, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Estimate)

February 24, 2014

Last Update Submitted That Met QC Criteria

February 21, 2014

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HN 4262

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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