Focus of the Study is on the Use of Incentives to PromoteNCT01616628
The Use of Incentives to Promote Healthier Eating in Low-income Communities
A study testing Fruit and vegetable rewards in people with Focus of the Study is on the Use of Incentives to Promote and Healthier Eating in Low-income Communities, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
Identifying effective strategies for improving healthier eating for low- income populations is both a clinical challenge and a public health priority. Approximately one-fifth of the children in the United States are either overweight or obese. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Focus of the Study is on the Use of Incentives to Promote, Healthier Eating in Low-income Communities
- What is being tested?
- Fruit and vegetable rewards
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Oct 2011
- 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
- Self-identified as primary shopper for household of at least 2 people [with at least one child between the ages of 5 and 16 years ]
- Has registered frequent shopper card for Fresh Grocer supermarkets
- Minimum 8 week history of shopping at this Fresh Grocer supermarket
- Shops at the identified supermarket at least 3 times a month
- Capable of providing informed consent.
- Has working contact telephone number and mailing address
- Able to communicate in English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Identifying effective strategies for improving healthier eating for low- income populations is both a clinical challenge and a public health priority. Approximately one-fifth of the children in the United States are either overweight or obese. Obesity is even more common in low- income populations as are other related health conditions such as diabetes, hypertension and cardiovascular diseases.
The consumption of fruits and vegetables is strongly associated with the prevention and management of obesity and diabetes and cardiovascular diseases. Overall, only about 38% of Americans consume the recommended servings of vegetables and only 23% consume the suggested amount of fruit. Close to 20% of low- income households do not purchase fruits and vegetables at all.
Read more
The proposed research offers an opportunity to investigate a different approach to incentives for healthier eating in a low-income urban population. Specifically, this study will examine a rewards-based incentive for fruit and vegetable purchases with rewards based on cumulative purchases. Previous studies have shown that incentives may be an effective means of promoting behavior change. The proposed study will provide essential data about the impact of targeted incentives to promote acquisition of fruits and vegetables by individuals living in households with young children. The investigators plan to design a subsequent, larger study based on the results of this study. In the proposed study, the investigators will specifically contribute to this knowledge by investigating the effects of rewards-based incentives that provide delayed reinforcement.
SPECIFIC AIMS AND STUDY HYPOTHESES
The goal of this study is to investigate whether incentives to low-income families to encourage purchase of healthier foods can be used to help stem the tide of childhood obesity. Although this study is a randomized trial, a major function is collecting data to be used in the design of a larger randomized controlled trial comparing two different interventions using incentives to promote healthier eating in low-income communities. The investigators will test a supermarket "gift card" with rewards based on purchases of fruits and vegetables during the intervention periods. The specific objective is to determine whether that incentive system-(where the rewards can be used to purchase anything in that supermarket) increases healthier food purchasing practices by low-income families. The primary outcomes are: number of servings, and percent of total food dollars spent on fruits and vegetables (fresh and frozen). The primary hypotheses are:
- Households in the intervention group will purchase more fruits and vegetables than controls per week, both during: a) each intervention phase as compared to the baseline period and b) in the follow up phase compared to the baseline period. (Between group comparisons over time of intervention versus control group) The secondary hypotheses are:
- Households in the intervention group will purchase more fruits and vegetables per week both during: a) each intervention phase as compared to the baseline period and b) in the follow up phase compared to baseline. (Within group comparisons over time)
- Conditions
- Focus of the Study is on the Use of Incentives to Promote, Healthier Eating in Low-income Communities
- Being tested
- Fruit and vegetable rewards
- Keywords
- Incentives, Fruit, Vegetables
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit and vegetable rewardsBehavioural
Participants earn reward points at 50% the rate of how much they spend on fruit and vegetables. The earned reward points are distributed as money added to gift cards to be redeemed at the market.
| Study group | Role | What they receive |
|---|---|---|
| Wait listed control | No intervention | Participants grocery shop without the intervention for extended baseline and have delayed entrance into the intervention period. |
| Rewards for purchases & topic education | Experimental | Participants earn reward points at 50% the rate of how much they spend on fruit and vegetables. Receives: Behavioral: Fruit and vegetable rewards |
What is being measured
The primary outcome is the main question the study is designed to answer.
Servings of fruit and vegetables
The number of servings of fruit and vegetables purchased per household per week
Measured: Participants will be followed for a minimum of 20 weeks
Secondary outcomes (1)
Cost of fruit and vegetables
The amount spent on fresh and frozen fruit and vegetables per household per week.
Measured: Participants will be followed for a minimum of 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startNov 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of the Study is on the Use of Incentives to PromoteStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Etienne Phipps, Albert Einstein Healthcare Network
- Investigators
- Etienne J Phipps, PhD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616628
- Sponsor's protocol ID
- 68246
- Status last verified
- Jun 2012
- First submitted
- 7 Jun 2012
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Incentives to Promote Healthier Eating in Low-income Communities
- ClinicalTrials.gov ID
- NCT01616628
- Acronym / sponsor ID
- 68246
- Conditions
- Focus of the Study is on the Use of Incentives to Promote, Healthier Eating in Low-income Communities
- Keywords
- Incentives, Fruit, Vegetables
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 12 Jun 2012 (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.
Identifying effective strategies for improving healthier eating for low- income populations is both a clinical challenge and a public health priority. Approximately one-fifth of the children in the United States are either overweight or obese. Obesity is even more common in low- income populations as are other related health conditions such as diabetes, hypertension and cardiovascular diseases.
The consumption of fruits and vegetables is strongly associated with the prevention and management of obesity and diabetes and cardiovascular diseases. Overall, only about 38% of Americans consume the recommended servings of vegetables and only 23% consume the suggested amount of fruit. Close to 20% of low- income households do not purchase fruits and vegetables at all.
The proposed research offers an opportunity to investigate a different approach to incentives for healthier eating in a low-income urban population. Specifically, this study will examine a rewards-based incentive for fruit and vegetable purchases with rewards based on cumulative purchases. Previous studies have shown that incentives may be an effective means of promoting behavior change. The proposed study will provide essential data about the impact of targeted incentives to promote acquisition of fruits and vegetables by individuals living in households with young children. The investigators plan to design a subsequent, larger study based on the results of this study. In the proposed study, the investigators will specifically contribute to this knowledge by investigating the effects of rewards-based incentives that provide delayed reinforcement.
SPECIFIC AIMS AND STUDY HYPOTHESES
The goal of this study is to investigate whether incentives to low-income families to encourage purchase of healthier foods can be used to help stem the tide of childhood obesity. Although this study is a randomized trial, a major function is collecting data to be used in the design of a larger randomized controlled trial comparing two different interventions using incentives to promote healthier eating in low-income communities. The investigators will test a supermarket "gift card" with rewards based on purchases of fruits and vegetables during the intervention periods. The specific objective is to determine whether that incentive system-(where the rewards can be used to purchase anything in that supermarket) increases healthier food purchasing practices by low-income families. The primary outcomes are: number of servings, and percent of total food dollars spent on fruits and vegetables (fresh and frozen). The primary hypotheses are:
- Households in the intervention group will purchase more fruits and vegetables than controls per week, both during: a) each intervention phase as compared to the baseline period and b) in the follow up phase compared to the baseline period. (Between group comparisons over time of intervention versus control group) The secondary hypotheses are:
- Households in the intervention group will purchase more fruits and vegetables per week both during: a) each intervention phase as compared to the baseline period and b) in the follow up phase compared to baseline. (Within group comparisons over time)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait listed control | No intervention | –Participants grocery shop without the intervention for extended baseline and have delayed entrance into the intervention period. |
| Rewards for purchases & topic education | Experimental | Behavioral: Fruit and vegetable rewardsParticipants earn reward points at 50% the rate of how much they spend on fruit and vegetables. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Self-identified as primary shopper for household of at least 2 people [with at least one child between the ages of 5 and 16 years ]
- Has registered frequent shopper card for Fresh Grocer supermarkets
- Minimum 8 week history of shopping at this Fresh Grocer supermarket
- Shops at the identified supermarket at least 3 times a month
- Capable of providing informed consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Fruit and vegetable rewardsParticipants earn reward points at 50% the rate of how much they spend on fruit and vegetables. The earned reward points are distributed as money added to gift cards to be redeemed at the market. | Behavioural | Rewards for purchases & topic education |
Primary outcome
Servings of fruit and vegetables
Time frame: Participants will be followed for a minimum of 20 weeks
The number of servings of fruit and vegetables purchased per household per week
1 secondary outcome
Cost of fruit and vegetables
Time frame: Participants will be followed for a minimum of 20 weeks
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 24 Jan 2017.
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.
Etienne J Phipps, PhD principal investigator
Albert Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruit and vegetable rewards in people with Focus of the Study is on the Use of Incentives to Promote and Healthier Eating in Low-income Communities, run by Albert Einstein Healthcare Network 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 7 inclusion and 0 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 24 Jan 2017. 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?
Servings of fruit and vegetables (time frame: Participants will be followed for a minimum of 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2017.