Food AssistanceGAPSNCT02643576
Grocery Assistance Program Study
A study testing F&V Bonus, Restriction and Bonus & Restriction in people with Food Assistance, run by University of Minnesota at 1 site in United States.
Trial summary
This highly innovative experimental trial is designed to examine the independent and joint effects of prohibiting the use of SNAP-like benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more healthful foods. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Assistance
- What is being tested?
- F&V Bonus, Restriction and Bonus & Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Mar 2016
- 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
- ≥ 18 years of age
- Primary food shopper of household
- Not currently participating in the Supplemental Nutrition Assistance Program (SNAP)
- Not planning to apply for SNAP in the next 4 months
- Able to read and write in English
- ≤ 8 people living in household
- Have a gross monthly income level that places the household at or below 200 percent of the Federal poverty level for their household size.
Who cannot join
- < 18 years of age
- Not primary food shopper of household
- Currently participating in the Supplemental Nutrition Assistance Program (SNAP)
- Planning to apply for SNAP in the next 4 months
- Unable to read and write in English
- > 8 people living in household
- Have a gross monthly income level that places the household above 200 percent of the Federal poverty level for their household size
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota School of Public Health
Minneapolis, Minnesota, 55454
About this study
Official title: Designing a Food Benefit Program to Optimize Diet Quality for Obesity Prevention
This highly innovative experimental trial is designed to examine the independent and joint effects of prohibiting the use of SNAP-like benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more healthful foods.
Read the detailed description
More than 1 in 10 Americans participate in the Supplemental Nutrition Assistance Program (SNAP), a Federal food and nutrition program administered by the United States Department of Agriculture (USDA). SNAP, formerly known as the Food Stamp Program, provides funds to low-income families for the purchase of food. Benefits are provided on an electronic benefits transfer (EBT) card that is used like an debit card at stores.
In recent years there has been growing recognition that SNAP participants are disproportionately obese, with poor diet contributing to this disparity. In response, there is great interest in considering ways in which SNAP may better meet its objective to help people and families buy the food they need for good health.
Modifications to SNAP currently under evaluation involve offering incentives to encourage participants to purchase more nutritious food items. There is concern, however, that this strategy alone may be of limited usefulness in improving the nutritional quality of the diet for obesity prevention because incentivizing the purchase of more nutritious foods does not necessarily reduce the purchase of less nutritious foods (substitution effect may not occur) and may even increase the total calories purchased.
An alternative strategy that has been extensively discussed by public health advocates and policy makers in recent years is prohibiting the purchase of less nutritious food items with SNAP benefits. Commonly consumed foods that are high in discretionary calories (defined as calories from solid fats, alcohol, and added sugars) are prime targets for exclusion because SNAP participants consume far more energy from discretionary calories (43%) than recommended. This strategy may be particularly effective if implemented in conjunction with incentives for the purchase of more nutritious foods.
No studies have been conducted to evaluate whether prohibiting the purchase of foods high in discretionary calories with SNAP benefits may improve diet quality and reduce risk of obesity. Likewise research is lacking on the effect of effect of pairing restrictions with incentives. Thus, we propose to pilot a highly innovative experimental trial designed to examine the independent and joint effects of prohibiting the use of SNAP benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more healthful foods. Key indicators of feasibility will include recruitment and retention (are targeted number of participants recruited and retained at a high rate?); fidelity of the intervention (are compliance measures successfully collected and do they indicate close compliance with experimental condition assignment?); and completeness of baseline and follow-up data.
Using study data, analyses will be conducted to evaluate the independent and joint effects of prohibiting the use of SNAP benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more nutritious foods.
- Conditions
- Food Assistance
- Being tested
- F&V Bonus, Restriction, Bonus & Restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F&V BonusBehavioural
To examine the independent effect of offering an incentive (i.e. bonus dollars for fruit and vegetable purchases) to SNAP-like benefits to encourage the purchase of more healthful foods
RestrictionBehavioural
To examine the independent effect of prohibiting the use of SNAP-like benefits to purchase foods high in discretionary calories (i.e.sugar-sweetened beverages, candy, or sweet baked goods) on food purchases and diet quality
Bonus & RestrictionBehavioural
To examine the joint effects of prohibiting the use of SNAP benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more healthful foods
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual SNAP-like food benefits |
| Rewards | Experimental | Usual SNAP-like food benefits, plus a modification to this food benefit program that entails a 30% bonus on eligible fruit and vegetable purchases (i.e. F\&V bonus) Receives: Behavioral: F&V Bonus |
| Restrictions | Experimental | Usual SNAP-like food benefits, plus a modification that requires no sugar-sweetened beverages, candy, or sweet baked goods be purchased Receives: Behavioral: Restriction |
| Rewards plus restrictions | Experimental | Usual SNAP-like food benefits, plus two modifications to this food benefit program: one modification includes a 30% bonus on eligible fruit and vegetable purchases and the other modification is that sugar-sweetened beverages, candy, or sweet baked goods are not allowed to be purchased (i.e. Bonus \& Restriction) Receives: Behavioral: Bonus & Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Total Kilocalorie intake at 16 weeks
Evaluate the independent and joint effects on dietary intake of prohibiting the use of SNAP benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more nutritious foods.
Measured: 16 weeks
Change from baseline in reported levels of household food security at 16 weeks
Assessing any change from baseline in the score of the The U.S. Household Food Security Survey Module: Six-Item Short Form
Measured: 16 weeks
Change from baseline in Healthy Eating Index (HEI) Score at 16 weeks
Evaluate the independent and joint effects on dietary intake of prohibiting the use of SNAP benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more nutritious foods. More information about the HEI score can be found here: http://nccor.org/projects/hei/
Measured: 16 weeks
Change from baseline in daily servings of fruits and vegetable (added together) at 16 weeks
Evaluate the independent and joint effects on dietary intake of prohibiting the use of SNAP benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more nutritious foods.
Servings of fruits and servings of vegetables are calculated from the output provided by NDS-R, which are based on the reported food intake as collected via 24-hour dietary recalls. Three recalls are collected at baseline and averaged; three recalls are collected at follow-up and averaged.
Measured: 16 weeks
Change from baseline in daily total, in grams, of added sugars at 16 weeks
Evaluate the independent and joint effects on dietary intake of prohibiting the use of SNAP benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more nutritious foods.
Measured: 16 weeks
Secondary outcomes (1)
Change from baseline in Body Mass Index
Evaluate the independent and joint effects on Body Mass Index of prohibiting the use of SNAP benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more nutritious foods.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Food AssistanceStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa J Harnack, DrPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643576
- Sponsor's protocol ID
- DK098152
- Other IDs
- R01DK098152
- Acronym
- GAPS
- Status last verified
- Oct 2017
- First submitted
- 22 Dec 2014
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Valluri S, Mason SM, Peterson HH, French SA, Harnack LJ. The impact of financial incentives and restrictions on cyclical food expenditures among low-income households receiving nutrition assistance: a randomized controlled trial. Int J Behav Nutr Phys Act. 2021 Dec 4;18(1):157. doi: 10.1186/s12966-021-01223-7.
PubMed 34863192French SA, Rydell SA, Mitchell NR, Michael Oakes J, Elbel B, Harnack L. Financial incentives and purchase restrictions in a food benefit program affect the types of foods and beverages purchased: results from a randomized trial. Int J Behav Nutr Phys Act. 2017 Sep 16;14(1):127. doi: 10.1186/s12966-017-0585-9.
PubMed 28915844Harnack L, Oakes JM, Elbel B, Beatty T, Rydell S, French S. Effects of Subsidies and Prohibitions on Nutrition in a Food Benefit Program: A Randomized Clinical Trial. JAMA Intern Med. 2016 Nov 1;176(11):1610-1618. doi: 10.1001/jamainternmed.2016.5633.
PubMed 27653735
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing a Food Benefit Program to Optimize Diet Quality for Obesity Prevention
- ClinicalTrials.gov ID
- NCT02643576
- Acronym / sponsor ID
- GAPS / DK098152
- Conditions
- Food Assistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2013 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 31 Dec 2015 (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.
This highly innovative experimental trial is designed to examine the independent and joint effects of prohibiting the use of SNAP-like benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more healthful foods.
Detailed description
More than 1 in 10 Americans participate in the Supplemental Nutrition Assistance Program (SNAP), a Federal food and nutrition program administered by the United States Department of Agriculture (USDA). SNAP, formerly known as the Food Stamp Program, provides funds to low-income families for the purchase of food. Benefits are provided on an electronic benefits transfer (EBT) card that is used like an debit card at stores.
In recent years there has been growing recognition that SNAP participants are disproportionately obese, with poor diet contributing to this disparity. In response, there is great interest in considering ways in which SNAP may better meet its objective to help people and families buy the food they need for good health.
Modifications to SNAP currently under evaluation involve offering incentives to encourage participants to purchase more nutritious food items. There is concern, however, that this strategy alone may be of limited usefulness in improving the nutritional quality of the diet for obesity prevention because incentivizing the purchase of more nutritious foods does not necessarily reduce the purchase of less nutritious foods (substitution effect may not occur) and may even increase the total calories purchased.
An alternative strategy that has been extensively discussed by public health advocates and policy makers in recent years is prohibiting the purchase of less nutritious food items with SNAP benefits. Commonly consumed foods that are high in discretionary calories (defined as calories from solid fats, alcohol, and added sugars) are prime targets for exclusion because SNAP participants consume far more energy from discretionary calories (43%) than recommended. This strategy may be particularly effective if implemented in conjunction with incentives for the purchase of more nutritious foods.
No studies have been conducted to evaluate whether prohibiting the purchase of foods high in discretionary calories with SNAP benefits may improve diet quality and reduce risk of obesity. Likewise research is lacking on the effect of effect of pairing restrictions with incentives. Thus, we propose to pilot a highly innovative experimental trial designed to examine the independent and joint effects of prohibiting the use of SNAP benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more healthful foods. Key indicators of feasibility will include recruitment and retention (are targeted number of participants recruited and retained at a high rate?); fidelity of the intervention (are compliance measures successfully collected and do they indicate close compliance with experimental condition assignment?); and completeness of baseline and follow-up data.
Using study data, analyses will be conducted to evaluate the independent and joint effects of prohibiting the use of SNAP benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more nutritious foods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual SNAP-like food benefits |
| Rewards | Experimental | Behavioral: F&V BonusUsual SNAP-like food benefits, plus a modification to this food benefit program that entails a 30% bonus on eligible fruit and vegetable purchases (i.e. F\&V bonus) |
| Restrictions | Experimental | Behavioral: RestrictionUsual SNAP-like food benefits, plus a modification that requires no sugar-sweetened beverages, candy, or sweet baked goods be purchased |
| Rewards plus restrictions | Experimental | Behavioral: Bonus & RestrictionUsual SNAP-like food benefits, plus two modifications to this food benefit program: one modification includes a 30% bonus on eligible fruit and vegetable purchases and the other modification is that sugar-sweetened beverages, candy, or sweet baked goods are not allowed to be purchased (i.e. Bonus \& Restriction) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years of age
- Primary food shopper of household
- Not currently participating in the Supplemental Nutrition Assistance Program (SNAP)
- Not planning to apply for SNAP in the next 4 months
- Able to read and write in English
Key exclusion criteria (7 listed)
- < 18 years of age
- Not primary food shopper of household
- Currently participating in the Supplemental Nutrition Assistance Program (SNAP)
- Planning to apply for SNAP in the next 4 months
- Unable to read and write in English
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 |
|---|---|---|
| F&V BonusTo examine the independent effect of offering an incentive (i.e. bonus dollars for fruit and vegetable purchases) to SNAP-like benefits to encourage the purchase of more healthful foods | Behavioural | Rewards |
| RestrictionTo examine the independent effect of prohibiting the use of SNAP-like benefits to purchase foods high in discretionary calories (i.e.sugar-sweetened beverages, candy, or sweet baked goods) on food purchases and diet quality | Behavioural | Restrictions |
| Bonus & RestrictionTo examine the joint effects of prohibiting the use of SNAP benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more healthful foods | Behavioural | Rewards plus restrictions |
Primary outcome
Change from baseline in Total Kilocalorie intake at 16 weeks
Time frame: 16 weeks
Evaluate the independent and joint effects on dietary intake of prohibiting the use of SNAP benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more nutritious foods.
Change from baseline in reported levels of household food security at 16 weeks
Time frame: 16 weeks
Assessing any change from baseline in the score of the The U.S. Household Food Security Survey Module: Six-Item Short Form
Change from baseline in Healthy Eating Index (HEI) Score at 16 weeks
Time frame: 16 weeks
Evaluate the independent and joint effects on dietary intake of prohibiting the use of SNAP benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more nutritious foods. More information about the HEI score can be found here: http://nccor.org/projects/hei/
Change from baseline in daily servings of fruits and vegetable (added together) at 16 weeks
Time frame: 16 weeks
Evaluate the independent and joint effects on dietary intake of prohibiting the use of SNAP benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more nutritious foods. Servings of fruits and servings of vegetables are calculated from the output provided by NDS-R, which are based on the reported food intake as collected via 24-hour dietary recalls. Three recalls are collected at baseline and averaged; three recalls are collected at follow-up and averaged.
Change from baseline in daily total, in grams, of added sugars at 16 weeks
Time frame: 16 weeks
Evaluate the independent and joint effects on dietary intake of prohibiting the use of SNAP benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more nutritious foods.
1 secondary outcome
Change from baseline in Body Mass Index
Time frame: 16 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 Oct 2017.
- Derived from this study: PubMed 34863192Valluri S, Mason SM, Peterson HH, French SA, Harnack LJ. The impact of financial incentives and restrictions on cyclical food expenditures among low-income households receiving nutrition assistance: a randomized controlled trial. Int J Behav Nutr Phys Act. 2021 Dec 4;18(1):157. doi: 10.1186/s12966-021-01223-7.
- Derived from this study: PubMed 28915844French SA, Rydell SA, Mitchell NR, Michael Oakes J, Elbel B, Harnack L. Financial incentives and purchase restrictions in a food benefit program affect the types of foods and beverages purchased: results from a randomized trial. Int J Behav Nutr Phys Act. 2017 Sep 16;14(1):127. doi: 10.1186/s12966-017-0585-9.
- Derived from this study: PubMed 27653735Harnack L, Oakes JM, Elbel B, Beatty T, Rydell S, French S. Effects of Subsidies and Prohibitions on Nutrition in a Food Benefit Program: A Randomized Clinical Trial. JAMA Intern Med. 2016 Nov 1;176(11):1610-1618. doi: 10.1001/jamainternmed.2016.5633.
- Brief Study Description \& Study Contact InformationLink provided by the sponsor.
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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.
Lisa J Harnack, DrPH principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F&V Bonus, Restriction and Bonus & Restriction in people with Food Assistance, run by University of Minnesota 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 7 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 Oct 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?
Change from baseline in Total Kilocalorie intake at 16 weeks (time frame: 16 weeks). The study lists 5 primary outcomes in all. 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 NCT02643576, which also lists 3 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 24 Oct 2017.