Nutrition TherapyWTENCT01436097
Randomized Trial of Healthy Eating Interventions
A study testing Information provision intervention, information provision + flat incentive and Information provision + tiered incentive in people with Nutrition Therapy, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition Therapy
- What is being tested?
- Information provision intervention, information provision + flat incentive and Information provision + tiered incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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).
Read the detailed description
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
- Nutrition Therapy
- Being tested
- Information provision intervention, information provision + flat incentive, Information provision + tiered incentive, Usual Care
- Keywords
- Healthy Eating, Health Behavior, Incentive, Work-site
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information provision interventionBehavioural
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 incentiveBehavioural
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 incentiveBehavioural
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.
Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Information provision + tiered incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: weekly for 3 months
Secondary outcomes (2)
Changes from baseline in self-reported consumption of fruits and vegetables
Changes from baseline in self-reported consumption of fruits and vegetables each week for 12 weeks across each intervention.
Measured: weekly for 3 months
Changes in body weight from baseline to end of treatment (12 weeks after intervention start)
Changes in body weight from baseline to end of treatment (12 weeks after intervention start; pre- and post- intervention).
Measured: Baseline and an average of 12-14 weeks after intervention start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Nutrition TherapyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Scott Halpern, University of Pennsylvania
- Investigators
- Scott D Halpern, MD, Ph.D., Principal investigator, University of PennsylvaniaKathryn A Saulsgiver, MS, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436097
- Sponsor's protocol ID
- WTE-814279
- Other IDs
- RC2AG036592
- Acronym
- WTE
- Status last verified
- Jan 2013
- First submitted
- 14 Sep 2011
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 9099655Lin, B. Diet Quality Usually Varies by Income Status. Washington, DC: U.S. Department of Agriculture, Economic Research Service. Amber Wave, 3(5), 2005.
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.
PubMed 11777675Blisard, 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.
PubMed 3920715Coulson 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.
PubMed 9158910Basiotis, 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.
PubMed 15313080Kristal 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.
PubMed 10168262French 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.
PubMed 15313079Glanz 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.
PubMed 15313077French 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.
PubMed 11189801Basiotis, 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentives for Healthy Eating: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT01436097
- Acronym / sponsor ID
- WTE / WTE-814279
- Conditions
- Nutrition Therapy
- Keywords
- Healthy Eating, Health Behavior, Incentive, Work-site
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Oct 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 19 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual Care arm | Active comparator | Behavioral: Usual CareParticipants 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 | Experimental | Behavioral: Information provision interventionParticipants 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. |
| Information provision + flat incentive | Experimental | Behavioral: information provision + flat incentiveParticipants 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. |
| Information provision + tiered incentive | Experimental | Behavioral: Information provision + tiered incentiveIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information provision interventionParticipant 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. | Behavioural | Information provision intervention |
| information provision + flat incentiveParticipants 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. | Behavioural | Information provision + flat incentive |
| Information provision + tiered incentiveIn 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. | Behavioural | Information provision + tiered incentive |
| Usual CareParticipants 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. | Behavioural | Usual Care arm |
Primary outcome
Changes from baseline in proportion of fruit and vegetable purchases
Time frame: 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.
2 secondary outcomes
Changes from baseline in self-reported consumption of fruits and vegetables
Time frame: weekly for 3 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
- Background: PubMed 9099655Appel 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.
- BackgroundLin, B. Diet Quality Usually Varies by Income Status. Washington, DC: U.S. Department of Agriculture, Economic Research Service. Amber Wave, 3(5), 2005.
- Background: PubMed 11777675Morland 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.
- BackgroundBlisard, N & Stewart, H. Food Spending in American Households, 2003-04. Economic Information Bulletin 59033, United States Department of Agriculture, Economic Research Service 2007.
- Results publication: PubMed 3920715Blair 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.
- Results publication: PubMed 9158910Coulson 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.
- Results publicationBasiotis, 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.
- Results publicationGarasky, 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.
- Results publication: PubMed 15313080Seymour 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.
- Results publication: PubMed 10168262Kristal 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.
- Results publication: PubMed 15313079French 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.
- Results publication: PubMed 15313077Glanz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott D Halpern, MD, Ph.D. principal investigator
University of Pennsylvania
Kathryn A Saulsgiver, MS, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information provision intervention, information provision + flat incentive and Information provision + tiered incentive in people with Nutrition Therapy, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in proportion of fruit and vegetable purchases (time frame: weekly for 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01436097, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2013.