Randomized Trial of Healthy Eating Interventions (WTE)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Scott Halpern, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01436097
First received: September 14, 2011
Last updated: January 14, 2013
Last verified: January 2013

September 14, 2011
January 14, 2013
October 2011
September 2012   (final data collection date for primary outcome measure)
Changes from baseline in proportion of fruit and vegetable purchases [ Time Frame: weekly for 3 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01436097 on ClinicalTrials.gov Archive Site
  • Changes from baseline in self-reported consumption of fruits and vegetables [ Time Frame: weekly for 3 months ] [ Designated as safety issue: No ]
    Changes from baseline in self-reported consumption of fruits and vegetables each week for 12 weeks across each intervention.
  • Changes in body weight from baseline to end of treatment (12 weeks after intervention start) [ Time Frame: Baseline and an average of 12-14 weeks after intervention start ] [ Designated as safety issue: No ]
    Changes in body weight from baseline to end of treatment (12 weeks after intervention start; pre- and post- intervention).
Same as current
Not Provided
Not Provided
 
Randomized Trial of Healthy Eating Interventions
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).

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Nutrition Therapy
  • Behavioral: Information provision 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.
  • Behavioral: information provision + flat incentive
    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.
  • Behavioral: Information provision + tiered incentive
    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.
  • Behavioral: Usual Care
    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.
  • Active Comparator: 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.
    Intervention: Behavioral: Usual Care
  • 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.
    Intervention: Behavioral: Information provision intervention
  • 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.
    Intervention: Behavioral: information provision + flat incentive
  • 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.
    Intervention: Behavioral: Information provision + tiered incentive

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01436097
WTE-814279, RC2AG036592
Yes
Scott Halpern, University of Pennsylvania
University of Pennsylvania
National Institute on Aging (NIA)
Principal Investigator: Scott D Halpern, MD, Ph.D. University of Pennsylvania
Principal Investigator: Kathryn A Saulsgiver, MS, PhD University of Pennsylvania
University of Pennsylvania
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP