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

Dietary Habits Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674751
• Other study ID #: HN 4262
• Status: Completed
• Phase: N/A
• First received: July 30, 2012
• Last updated: February 21, 2014
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: August 2012
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dietary Habits

Intervention

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.

Locations

Country	Name	City	State
United States	Albert Einstein Healthcare Network	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network	Aramark Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Total number of calories from fat	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.	No
Secondary	Participant adherence	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	No
Secondary	Participant body weight (kg)	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	No
Secondary	Hemoglobin A1c (HbA1c)	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	No
Secondary	Cholesterol subfractions	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	No
Secondary	Blood pressure (mmHg)	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	No
Secondary	Mindful eating score on 28-item self-report measure	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	No