Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141, United States
NCT Number: NCT01674751
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19141, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
Albert Einstein Healthcare Network
Other
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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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