Randomized Trial of Healthy Eating Interventions

NCT01436097 | Completed DMC

• 2 other identifiers: WTE-814279RC2AG036592
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Nutrition Therapy

Keywords

Healthy Eating; Health Behavior; Incentive; Work-site

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in proportion of fruit and vegetable purchases

  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

Secondary Outcomes (2)

• Changes from baseline in self-reported consumption of fruits and vegetables

  weekly for 3 months

• Changes in body weight from baseline to end of treatment (12 weeks after intervention start)

  Baseline and an average of 12-14 weeks after intervention start

Study Arms (4)

Usual Care arm

ACTIVE COMPARATOR

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.

Behavioral: Usual Care

Information provision intervention

EXPERIMENTAL

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.

Behavioral: Information provision intervention

Information provision + flat incentive

EXPERIMENTAL

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.

Behavioral: information provision + flat incentive

Information provision + tiered incentive

EXPERIMENTAL

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.

Behavioral: Information provision + tiered incentive

Interventions

Information provision intervention BEHAVIORAL

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.

Information provision intervention

information provision + flat incentive BEHAVIORAL

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.

Information provision + flat incentive

Information provision + tiered incentive BEHAVIORAL

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.

Information provision + tiered incentive

Usual Care BEHAVIORAL

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.

Usual Care arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• weekly grocery shoppers

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (22)

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• Basiotis, PP, Carlson, A, Gerrior, SA, Juan, WY, & Lino, M. The Healthy Eating Index: 1999-2000. U.S. Department of Agriculture, Center for Nutrition Policy and Promotion. CNPP-12, 2002

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• Lin, BH, Yen, ST, Dong, D, & Smallwood, DM. Economic incentives for dietary improvement among food stamp recipients. Contemporary Economic Policy 28 (4): 524-536, 2010

  RESULT

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• Halpern SD, Karlawish JH, Casarett D, Berlin JA, Asch DA. Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials. Arch Intern Med. 2004 Apr 12;164(7):801-3. doi: 10.1001/archinte.164.7.801.

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• Halpern SD, Raz A, Kohn R, Rey M, Asch DA, Reese P. Regulated payments for living kidney donation: an empirical assessment of the ethical concerns. Ann Intern Med. 2010 Mar 16;152(6):358-65. doi: 10.7326/0003-4819-152-6-201003160-00005.

  PMID: 20231566 RESULT

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Scott D Halpern, MD, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Kathryn A Saulsgiver, MS, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine (Pulmonary & Critical Care) and Epidemiology Deputy Director, Center for Health Incentives and Behavioral Economics

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 19, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

US (1)