NCT01674751

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 29, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 24, 2014

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

July 30, 2012

Last Update Submit

February 21, 2014

Conditions

Keywords

pre-orderinghealthy eatingmindfulnessincentivesemployees

Outcome Measures

Primary Outcomes (1)

  • Total number of calories

    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 Outcomes (7)

  • Total number of calories from fat

    Participants are followed for a minimum of 12 weeks and the total calories from fat in their lunchtime meals are recorded daily.

  • Participant adherence

    Participants are followed for a minimum of 12 weeks

  • Participant body weight (kg)

    Recorded at the time of recruitment into the study and again following the 8 week intervention

  • Hemoglobin A1c (HbA1c)

    Measured at the time of recruitment into the study and again following the 8 week intervention

  • Cholesterol subfractions

    Measured at the time of recruitment into the study and again following the 8 week intervention

  • +2 more secondary outcomes

Study Arms (2)

Immediate intervention

EXPERIMENTAL

Group begins the 4 week Pre-Ordering Program intervention immediately following a 4-wk baseline period.

Other: Pre-ordering program

Wait-listed control

OTHER

Group begins the 4 week Pre-Ordering Program intervention following an 8-wk baseline period.

Other: Pre-ordering program

Interventions

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.

Immediate interventionWait-listed control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Etienne J Phipps, PhD

    Albert Einstein Healthcare Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Einstein Urban Health

Study Record Dates

First Submitted

July 30, 2012

First Posted

August 29, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

February 24, 2014

Record last verified: 2012-08

Locations