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Completed

NCT Number: NCT01674751

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pre-ordering program

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Albert Einstein Healthcare Network

Other

Collaborators

  • Aramark Healthcare

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Aug 29, 2012
Registry last updated
Feb 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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