Dietary HabitsNCT01674751
What to Eat for Lunch? A Pilot Study to Improve Healthier Eating at Work
A study testing Pre-ordering program in people with Dietary Habits, run by Albert Einstein Healthcare Network at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits
- What is being tested?
- Pre-ordering program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
About this study
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).
Read more
Our primary hypotheses are that:
- Participants will purchase lunches with fewer calories during the intervention compared to baseline.
- 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.
- Conditions
- Dietary Habits
- Being tested
- Pre-ordering program
- Keywords
- pre-ordering, healthy eating, mindfulness, incentives, employees
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-ordering programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate intervention | Experimental | Group begins the 4 week Pre-Ordering Program intervention immediately following a 4-wk baseline period. Receives: Other: Pre-ordering program |
| Wait-listed control | Other | Group begins the 4 week Pre-Ordering Program intervention following an 8-wk baseline period. Receives: Other: Pre-ordering program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of calories
The average number of calories (Kcal) purchased for lunch.
Measured: 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
The average number of calories from fat (g) purchased for lunch.
Measured: Participants are followed for a minimum of 12 weeks and the total calories from fat in their lunchtime meals are recorded daily.
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.
Measured: Participants are followed for a minimum of 12 weeks
Participant body weight (kg)
The average percent change in body weight from baseline to end of the intervention.
Measured: Recorded at the time of recruitment into the study and again following the 8 week intervention
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: Measured at the time of recruitment into the study and again following the 8 week intervention
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: Measured at the time of recruitment into the study and again following the 8 week intervention
Blood pressure (mmHg)
The average change in blood pleasure (mmHg) will be reported.
Measured: 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
The average change in mindfulness when eating will be reported.
Measured: Recorded at the time of recruitment into the study and again following the 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Collaborators
- Aramark Healthcare
- Responsible party
- Principal investigator, Etienne Phipps, Albert Einstein Healthcare Network
- Investigators
- Etienne J Phipps, PhD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674751
- Sponsor's protocol ID
- HN 4262
- Status last verified
- Aug 2012
- First submitted
- 30 Jul 2012
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What to Eat for Lunch? A Pilot Study to Improve Healthier Eating at Work
- ClinicalTrials.gov ID
- NCT01674751
- Acronym / sponsor ID
- HN 4262
- Conditions
- Dietary Habits
- Keywords
- pre-ordering, healthy eating, mindfulness, incentives, employees
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Collaborators
- Aramark Healthcare
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Participants will purchase lunches with fewer calories during the intervention compared to baseline.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention | Experimental | Other: Pre-ordering programGroup begins the 4 week Pre-Ordering Program intervention immediately following a 4-wk baseline period. |
| Wait-listed control | Other | Other: Pre-ordering programGroup begins the 4 week Pre-Ordering Program intervention following an 8-wk baseline period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-ordering programDuring 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 | Immediate intervention, Wait-listed control |
Primary outcome
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.
7 secondary outcomes
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.
Participant adherence
Time frame: 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
Hemoglobin A1c (HbA1c)
Time frame: 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
Blood pressure (mmHg)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
Related trials for Dietary Habits
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
Not yet recruiting
Project GAME ON! A Digital Comic Tool to Promote Healthy Behaviors
Obesity & Overweight, Childhood
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
Recruiting
Can Food Timing Reduce Your Diabetes Risk?
Dietary Habits
Recruiting
Nutrition for Precision Health, Powered by the All of Us
Nutrition, Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne J Phipps, PhD principal investigator
Albert Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-ordering program in people with Dietary Habits, run by Albert Einstein Healthcare Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2014.