Randomized Trial of Healthy Eating Interventions

NCT ID: NCT01436097

Last Updated: 2013-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-09-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Nutrition Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Information provision intervention

Intervention Type 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 + 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.

Group Type EXPERIMENTAL

information provision + flat incentive

Intervention Type 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 + 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.

Group Type EXPERIMENTAL

Information provision + tiered incentive

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Scott Halpern

Assistant Professor of Medicine (Pulmonary & Critical Care) and Epidemiology Deputy Director, Center for Health Incentives and Behavioral Economics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott D Halpern, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Kathryn A Saulsgiver, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997 Apr 17;336(16):1117-24. doi: 10.1056/NEJM199704173361601.

Reference Type BACKGROUND
PMID: 9099655 (View on PubMed)

Lin, B. Diet Quality Usually Varies by Income Status. Washington, DC: U.S. Department of Agriculture, Economic Research Service. Amber Wave, 3(5), 2005.

Reference Type BACKGROUND

Morland K, Wing S, Diez Roux A, Poole C. Neighborhood characteristics associated with the location of food stores and food service places. Am J Prev Med. 2002 Jan;22(1):23-9. doi: 10.1016/s0749-3797(01)00403-2.

Reference Type BACKGROUND
PMID: 11777675 (View on PubMed)

Blisard, N & Stewart, H. Food Spending in American Households, 2003-04. Economic Information Bulletin 59033, United States Department of Agriculture, Economic Research Service 2007.

Reference Type BACKGROUND

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Reference Type RESULT
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Coulson NS, Eiser C, Eiser JR. Diet, smoking and exercise: interrelationships between adolescent health behaviours. Child Care Health Dev. 1997 May;23(3):207-16. doi: 10.1111/j.1365-2214.1997.tb00964.x.

Reference Type RESULT
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Basiotis, PP, Carlson, A, Gerrior, SA, Juan, WY, & Lino, M. Nutrition Insight 28: Report Card on the Quality of Americans' Diets. Family Economics and Nutrition Review 16(2): 66-68, 2004.

Reference Type RESULT

Garasky, S, Morton, LW, & Greder, K. The Food Environment and Food Insecurity: Perceptions of Rural, Suburban, and Urban Food Pantry Clients in Iowa. Family Economics and Nutrition Review 16(2): 41-48, 2004.

Reference Type RESULT

Seymour JD, Yaroch AL, Serdula M, Blanck HM, Khan LK. Impact of nutrition environmental interventions on point-of-purchase behavior in adults: a review. Prev Med. 2004 Sep;39 Suppl 2:S108-36. doi: 10.1016/j.ypmed.2004.04.002.

Reference Type RESULT
PMID: 15313080 (View on PubMed)

Kristal AR, Goldenhar L, Muldoon J, Morton RF. Evaluation of a supermarket intervention to increase consumption of fruits and vegetables. Am J Health Promot. 1997 Jul-Aug;11(6):422-5. doi: 10.4278/0890-1171-11.6.422.

Reference Type RESULT
PMID: 10168262 (View on PubMed)

French SA, Wechsler H. School-based research and initiatives: fruit and vegetable environment, policy, and pricing workshop. Prev Med. 2004 Sep;39 Suppl 2:S101-7. doi: 10.1016/j.ypmed.2003.10.007.

Reference Type RESULT
PMID: 15313079 (View on PubMed)

Glanz K, Hoelscher D. Increasing fruit and vegetable intake by changing environments, policy and pricing: restaurant-based research, strategies, and recommendations. Prev Med. 2004 Sep;39 Suppl 2:S88-93. doi: 10.1016/j.ypmed.2004.03.002.

Reference Type RESULT
PMID: 15313077 (View on PubMed)

French SA, Jeffery RW, Story M, Breitlow KK, Baxter JS, Hannan P, Snyder MP. Pricing and promotion effects on low-fat vending snack purchases: the CHIPS Study. Am J Public Health. 2001 Jan;91(1):112-7. doi: 10.2105/ajph.91.1.112.

Reference Type RESULT
PMID: 11189801 (View on PubMed)

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

Reference Type RESULT

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

Reference Type RESULT

He FJ, Nowson CA, Lucas M, MacGregor GA. Increased consumption of fruit and vegetables is related to a reduced risk of coronary heart disease: meta-analysis of cohort studies. J Hum Hypertens. 2007 Sep;21(9):717-28. doi: 10.1038/sj.jhh.1002212. Epub 2007 Apr 19.

Reference Type RESULT
PMID: 17443205 (View on PubMed)

Mann J, Aune D. Can specific fruits and vegetables prevent diabetes? BMJ. 2010 Aug 18;341:c4395. doi: 10.1136/bmj.c4395. No abstract available.

Reference Type RESULT
PMID: 20724401 (View on PubMed)

Brown L, Rimm EB, Seddon JM, Giovannucci EL, Chasan-Taber L, Spiegelman D, Willett WC, Hankinson SE. A prospective study of carotenoid intake and risk of cataract extraction in US men. Am J Clin Nutr. 1999 Oct;70(4):517-24. doi: 10.1093/ajcn/70.4.517.

Reference Type RESULT
PMID: 10500021 (View on PubMed)

Christen WG, Liu S, Schaumberg DA, Buring JE. Fruit and vegetable intake and the risk of cataract in women. Am J Clin Nutr. 2005 Jun;81(6):1417-22. doi: 10.1093/ajcn/81.6.1417.

Reference Type RESULT
PMID: 15941896 (View on PubMed)

Drewnowski A. The cost of US foods as related to their nutritive value. Am J Clin Nutr. 2010 Nov;92(5):1181-8. doi: 10.3945/ajcn.2010.29300. Epub 2010 Aug 18.

Reference Type RESULT
PMID: 20720258 (View on PubMed)

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.

Reference Type RESULT
PMID: 15078651 (View on PubMed)

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.

Reference Type RESULT
PMID: 20231566 (View on PubMed)

Other Identifiers

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RC2AG036592

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WTE-814279

Identifier Type: -

Identifier Source: org_study_id

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