What to Eat for Lunch? A Pilot Study to Improve Healthier Eating at Work
21 lutego 2014 zaktualizowane przez: Etienne Phipps, Albert Einstein Healthcare Network
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.
Przegląd badań
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
31
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19141
- Albert Einstein Healthcare Network
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Immediate intervention
Group begins the 4 week Pre-Ordering Program intervention immediately following a 4-wk baseline period.
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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.
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Inny: Wait-listed control
Group begins the 4 week Pre-Ordering Program intervention following an 8-wk baseline period.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Total number of calories
Ramy czasowe: Participants are followed for a minimum of 12 weeks and the total calories from their lunchtime meals are recorded daily.
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The average number of calories (Kcal) purchased for lunch.
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Participants are followed for a minimum of 12 weeks and the total calories from their lunchtime meals are recorded daily.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Total number of calories from fat
Ramy czasowe: Participants are followed for a minimum of 12 weeks and the total calories from fat in their lunchtime meals are recorded daily.
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The average number of calories from fat (g) purchased for lunch.
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Participants are followed for a minimum of 12 weeks and the total calories from fat in their lunchtime meals are recorded daily.
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Participant adherence
Ramy czasowe: Participants are followed for a minimum of 12 weeks
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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.
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Participants are followed for a minimum of 12 weeks
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Participant body weight (kg)
Ramy czasowe: Recorded at the time of recruitment into the study and again following the 8 week intervention
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The average percent change in body weight from baseline to end of the intervention.
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Recorded at the time of recruitment into the study and again following the 8 week intervention
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Hemoglobin A1c (HbA1c)
Ramy czasowe: Measured at the time of recruitment into the study and again following the 8 week intervention
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The average change in participant Hemoglobin A1c (HbA1c, mmol/mol) will be reported in order to assess change in average plasma glucose concentrations.
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Measured at the time of recruitment into the study and again following the 8 week intervention
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Cholesterol subfractions
Ramy czasowe: Measured at the time of recruitment into the study and again following the 8 week intervention
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The average change in participant cholesterol subfractions (g/mL) will be reported in order to evaluate change in risk of coronary heart disease.
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Measured at the time of recruitment into the study and again following the 8 week intervention
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Blood pressure (mmHg)
Ramy czasowe: Measured at the time of recruitment into the study and again following the 8 week intervention
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The average change in blood pleasure (mmHg) will be reported.
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Measured at the time of recruitment into the study and again following the 8 week intervention
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Mindful eating score on 28-item self-report measure
Ramy czasowe: Recorded at the time of recruitment into the study and again following the 8 week intervention
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The average change in mindfulness when eating will be reported.
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Recorded at the time of recruitment into the study and again following the 8 week intervention
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Etienne J Phipps, PhD, Albert Einstein Healthcare Network
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 czerwca 2012
Zakończenie podstawowe (Rzeczywisty)
1 grudnia 2012
Ukończenie studiów (Rzeczywisty)
1 grudnia 2013
Daty rejestracji na studia
Pierwszy przesłany
30 lipca 2012
Pierwszy przesłany, który spełnia kryteria kontroli jakości
27 sierpnia 2012
Pierwszy wysłany (Oszacować)
29 sierpnia 2012
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
24 lutego 2014
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
21 lutego 2014
Ostatnia weryfikacja
1 sierpnia 2012
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- HN 4262
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .