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Randomized Trial of Healthy Eating Interventions (WTE)

14 de enero de 2013 actualizado por: Scott Halpern, University of Pennsylvania

Financial Incentives for Healthy Eating: A Randomized Pilot Study

Interventions to increase the consumption of fruits and vegetables to date have shown promise, but many have limited public health impact due to the lack of scalability of their designs. The investigators propose to examine the effectiveness and feasibility of an intervention for promoting increased consumption of fruits and vegetables by incentivizing their purchase. Collaborating with UpLift Solutions, the investigators will enroll shoppers in this Randomized Clinical Trial using the research infrastructure called the Way to Health platform. (called the Way to Health platform, and approved as a Prime protocol by the IRB as reference # 811860).

Hypothesis: providing patients with financial incentives can promote healthier behaviors (e.g.: eating healthier).

Descripción general del estudio

Descripción detallada

This is a pilot study under the IRB-approved umbrella protocol number 811698 named Penn-CMU Roybal Center on Behavioral Economics and Health. Interventions to increase the consumption of fruits and vegetables to date have shown promise, but many have limited public health impact due to the lack of scalability of their designs. Many interventions only provided information on what constitutes healthier eating or provided discounts on specific products.Other interventions were limited in generalizability due to utilization of very specific eating establishments or vending machines.By contrast, the investigators propose to examine the effectiveness and feasibility of an intervention for promoting increased consumption of fruits and vegetables by incentivizing their purchase where the overwhelming majority of food is sold: grocery stores. Collaborating with Brown's Super Stores and UpLift Solutions leadership, the investigators will enroll shoppers in this Randomized Clinical Trial using our the web-based research infrastructure called the Way to Health platform.

The primary aim of this project is to generate preliminary evidence of the efficacy of two financial incentive structures in promoting the allocation of a greater percentage of ones grocery budget to the purchase of fresh fruits and vegetables (hereafter, produce). Secondary aims are to evaluate these interventions effects on (1) self-reported consumption of produce, and (2) weight. Salutary goals of this pilot study are to document feasibility of using Price Plus cards for incentive studies, and to expand the functionality of the Way Health platform.

Tipo de estudio

Intervencionista

Inscripción (Actual)

42

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • University of Pennsylvania

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Current Parkside Brown's Super Stores shoppers who use a Price Plus Card
  • Have regular internet access
  • Spend at least $30 per household member per week on groceries
  • Spend 10% or less of their grocery budget on produce
  • 18 years of age or older
  • weekly grocery shoppers

Exclusion Criteria:

  • Plan to move in the next 4 months
  • Plan to stop shopping at Brown's Super Stores in the next 4 months
  • Plan to stop using their Price Plus card in the next 4 months
  • Receive any assistance like SNAP or WIC

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Usual Care arm
Participants will have access through the Way to Health portal to web-based educational materials and recipes related to healthy eating. They will be informed they will receive up to $50 in reimbursements for completing the surveys that are part of the Way To Eat program as follows: $20 for completing the intake questionnaire and weigh-in and $30 reimbursements for completing the exit questionnaire and weigh-in.
Participants will have access through the Way to Health portal to web-based educational materials and recipes related to healthy eating. They will be informed they will receive up to $50 in reimbursements for completing the surveys that are part of the Way To Eat program as follows: $20 for completing the intake questionnaire and weigh-in and $30 reimbursements for completing the exit questionnaire and weigh-in.
Experimental: Information provision intervention
Participants in the Information provision group will receive the same care as those in the Usual Care arm. In addition, the Information provision group participants will receive weekly reminders about the benefits of eating five servings of fruits and vegetables a day and their Way to Health portal will provide graphical depictions of their produce purchase proportions through information from their Price Plus card. This data will be available to them throughout the entire intervention.
Participant will have access to weekly data showing how much produce they are purchasing. No incentives will be given under this arm. They will also receiving information on weekly purchases, online resources, and weekly reminders on eating healthy.
Experimental: Information provision + flat incentive
Participants assigned to the Information provision + flat group will earn back 15% of what they spent on groceries for the week if they spend at least 15% of their total grocery budget on fresh produce in addition to receiving the same treatment as the Information provision arm.
Participants will earn back 15% of what they spent on groceries for the week if they spend at least 15% of their total grocery budget on fresh produce in addition to receiving the same treatment as the IP arm. They will also receiving information on weekly purchases, online resources, and weekly reminders on eating healthy.
Experimental: Information provision + tiered incentive
In addition to receiving all features of the Information provision treatment the participants assigned to the Information provision + tiered incentive group would earn back increasing percentages of their grocery spending for meeting increasing targets of produce consumption. In this arm, the more participants spend on produce the more money they can earn back.
In addition to receiving information on weekly purchases, online resources, and weekly reminders on eating healthy the participants assigned to the IP + tiered incentive group would earn back increasing percentages of their grocery spending for meeting increasing targets of produce consumption.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes from baseline in proportion of fruit and vegetable purchases
Periodo de tiempo: weekly for 3 months
Changes from baseline in proportion of grocery money that is spent on fruits and vegetables each week for 12 weeks across each intervention group. Fruits and vegetables, or produce, will be defined by the food product itself, not its location in the store. Produce in this study will include frozen and canned fruits and vegetables as well as fresh fruits and vegetables.
weekly for 3 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes from baseline in self-reported consumption of fruits and vegetables
Periodo de tiempo: weekly for 3 months
Changes from baseline in self-reported consumption of fruits and vegetables each week for 12 weeks across each intervention.
weekly for 3 months
Changes in body weight from baseline to end of treatment (12 weeks after intervention start)
Periodo de tiempo: Baseline and an average of 12-14 weeks after intervention start
Changes in body weight from baseline to end of treatment (12 weeks after intervention start; pre- and post- intervention).
Baseline and an average of 12-14 weeks after intervention start

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Scott D Halpern, MD, Ph.D., University of Pennsylvania
  • Investigador principal: Kathryn A Saulsgiver, MS, PhD, University of Pennsylvania

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de octubre de 2011

Finalización primaria (Actual)

1 de septiembre de 2012

Finalización del estudio (Actual)

1 de septiembre de 2012

Fechas de registro del estudio

Enviado por primera vez

14 de septiembre de 2011

Primero enviado que cumplió con los criterios de control de calidad

16 de septiembre de 2011

Publicado por primera vez (Estimar)

19 de septiembre de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

15 de enero de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

14 de enero de 2013

Última verificación

1 de enero de 2013

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • WTE-814279
  • RC2AG036592 (Subvención/contrato del NIH de EE. UU.)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Usual Care

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