- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01436097
Randomized Trial of Healthy Eating Interventions (WTE)
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).
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Changes from baseline in proportion of fruit and vegetable purchases
Prazo: weekly for 3 months
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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.
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weekly for 3 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Changes from baseline in self-reported consumption of fruits and vegetables
Prazo: weekly for 3 months
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Changes from baseline in self-reported consumption of fruits and vegetables each week for 12 weeks across each intervention.
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weekly for 3 months
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Changes in body weight from baseline to end of treatment (12 weeks after intervention start)
Prazo: Baseline and an average of 12-14 weeks after intervention start
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Changes in body weight from baseline to end of treatment (12 weeks after intervention start; pre- and post- intervention).
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Baseline and an average of 12-14 weeks after intervention start
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Scott D Halpern, MD, Ph.D., University of Pennsylvania
- Investigador principal: Kathryn A Saulsgiver, MS, PhD, University of Pennsylvania
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- Lin, B. Diet Quality Usually Varies by Income Status. Washington, DC: U.S. Department of Agriculture, Economic Research Service. Amber Wave, 3(5), 2005.
- Blisard, N & Stewart, H. Food Spending in American Households, 2003-04. Economic Information Bulletin 59033, United States Department of Agriculture, Economic Research Service 2007.
- Blair SN, Jacobs DR Jr, Powell KE. Relationships between exercise or physical activity and other health behaviors. Public Health Rep. 1985 Mar-Apr;100(2):172-80.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datas de registro do estudo
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Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
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Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
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Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- WTE-814279
- RC2AG036592 (Concessão/Contrato do NIH dos EUA)
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