Nutritional QualityNCT03363048
Grocery Assistance Program Study for Families
A study testing Restricted and Restriction plus Incentive in people with Nutritional Quality and Food Insecurity, run by University of Minnesota at 1 site in United States.
Trial summary
An experimental trial will be conducted whereby a Supplemental Nutrition Assistance Program (SNAP)-like food benefit program will be implemented in 240 SNAP eligible households. Baseline and follow up measures will include three 24-hour dietary recalls; household food purchase receipt collection; and household food… Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutritional Quality, Food Insecurity, Food Legislation
- What is being tested?
- Restricted and Restriction plus Incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 646 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2018to 6 Oct 2019
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- SNAP-eligible household
- at least one child between the ages of 3-11
- Less than or equal to 6 people in the household
- Primary food shopper
- Ability and willingness to collect and submit household food purchase receipts for 22 weeks
- Willingness to attend two study visits
Show all 9Show fewer
- willingness to complete three dietary recalls at both baseline and follow-up
- not planning to apply for SNAP in the next 5 months
- ability to speak and understand either Spanish or English
Who cannot join
- households that are not SNAP-eligible
- no children in household between the ages of 3-11
- not primary food shopper
- 7 or more people in household
- inability to collect and submit household food purchase receipts for 22 weeks
- unwillingness to comply with study measures
- inability to speak or understand Spanish or English
- planning on applying for SNAP within the next 5 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, School of Public Health, Division of Epidemiology & Community Health
Minneapolis, Minnesota, 55454
About this study
Official title: Effects of Subsidies and Prohibitions on Household Nutrition in a Food Benefit Program
An experimental trial will be conducted whereby a Supplemental Nutrition Assistance Program (SNAP)-like food benefit program will be implemented in 240 SNAP eligible households. Baseline and follow up measures will include three 24-hour dietary recalls; household food purchase receipt collection; and household food security questions. The individual level measures will be collected from the adult most responsible for food shopping and a child in the household. After baseline measures are completed households will be randomized to one of three conditions: 1) restriction (not allowed to buy sugar sweetened beverages, sweet baked goods, or candies with food benefits); 2) restriction paired with an incentive (30% financial incentive on fruits and vegetables and restriction of purchase of sugar sweetened beverages, sweet baked goods, or candy with food benefits); or 3) control (no incentive or restrictions). Households in all conditions will be given a debit card that will have funds added monthly for a five month period. The dollar amount placed on the card monthly will be similar to the amount the household would receive if enrolled in SNAP. All participants will be instructed to use the debit card for food purchases only, and they'll be told they shouldn't use the card to purchase items currently non-eligible for purchase with SNAP benefits (e.g. alcohol, food from restaurants). Those in the restriction condition will also be told they cannot use the card to buy sugar sweetened beverages, sweet baked goods, or candies. They may purchase these foods using their own money, but not the debit card. Those in the restriction plus incentive condition will receive the instructions provided to the restriction group plus they will be told that they'll receive a 30% bonus for fruits and vegetables purchased using their debit card. Analyses will determine whether the nutritional quality of the diet at follow-up differs between experimental groups.
- Being tested
- Restricted, Restriction plus Incentive
- Keywords
- Food restrictions/incentives, Food Stamp program, Policy change, Supplemental Nutrition Assistance Program (SNAP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestrictedBehavioural
Certain foods and beverages are not allowed to be purchased with food benefit dollars.
Restriction plus IncentiveBehavioural
Certain foods and beverages are not allowed to be purchased with food benefit dollars; 30% of the total dollars spent toward the purchase of certain foods result are added to their food benefit dollars.
| Study group | Role | What they receive |
|---|---|---|
| Restricted | Experimental | Not described Receives: Behavioral: Restricted |
| Restriction plus Incentive | Experimental | Not described Receives: Behavioral: Restriction plus Incentive |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Nutritional Quality as measured by the Healthy Eating Index (HEI)-2015 score
Overall Nutritional Quality obtained from average intake of three dietary recalls at both baseline and follow-up.
Measured: 18 weeks
Secondary outcomes (3)
Total Energy Intake
Measured: 18 weeks
Scores of 3 components (whole fruits, total vegetable, and added sugar) of the HEI-2015
Measured: 18 weeks
Household food insecurity
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start2 May 2018
- Primary completion6 Oct 2019
- Study completion6 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional QualityStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 646 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363048
- Sponsor's protocol ID
- STUDY00002037
- Status last verified
- Nov 2020
- First submitted
- 29 Nov 2017
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be placed on the Open Science Framework in compliance with Laura and John Arnold Foundation (LJAF) policies.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Subsidies and Prohibitions on Household Nutrition in a Food Benefit Program
- ClinicalTrials.gov ID
- NCT03363048
- Acronym / sponsor ID
- STUDY00002037
- Keywords
- Food restrictions/incentives, Food Stamp program, Policy change, Supplemental Nutrition Assistance Program (SNAP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 646 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 6 Oct 2019 (actual)
- Study completion
- 6 Oct 2019 (actual)
- First posted
- 5 Dec 2017 (actual)
- 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.
An experimental trial will be conducted whereby a Supplemental Nutrition Assistance Program (SNAP)-like food benefit program will be implemented in 240 SNAP eligible households. Baseline and follow up measures will include three 24-hour dietary recalls; household food purchase receipt collection; and household food security questions. The individual level measures will be collected from the adult most responsible for food shopping and a child in the household. After baseline measures are completed households will be randomized to one of three conditions: 1) restriction (not allowed to buy sugar sweetened beverages, sweet baked goods, or candies with food benefits); 2) restriction paired with an incentive (30% financial incentive on fruits and vegetables and restriction of purchase of sugar sweetened beverages, sweet baked goods, or candy with food benefits); or 3) control (no incentive or restrictions). Households in all conditions will be given a debit card that will have funds added monthly for a five month period. The dollar amount placed on the card monthly will be similar to the amount the household would receive if enrolled in SNAP. All participants will be instructed to use the debit card for food purchases only, and they'll be told they shouldn't use the card to purchase items currently non-eligible for purchase with SNAP benefits (e.g. alcohol, food from restaurants). Those in the restriction condition will also be told they cannot use the card to buy sugar sweetened beverages, sweet baked goods, or candies. They may purchase these foods using their own money, but not the debit card. Those in the restriction plus incentive condition will receive the instructions provided to the restriction group plus they will be told that they'll receive a 30% bonus for fruits and vegetables purchased using their debit card. Analyses will determine whether the nutritional quality of the diet at follow-up differs between experimental groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Restricted | Experimental | Behavioral: Restricted |
| Restriction plus Incentive | Experimental | Behavioral: Restriction plus Incentive |
| Control | No intervention | – |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- SNAP-eligible household
- at least one child between the ages of 3-11
- Less than or equal to 6 people in the household
- Primary food shopper
- Ability and willingness to collect and submit household food purchase receipts for 22 weeks
Key exclusion criteria (8 listed)
- households that are not SNAP-eligible
- no children in household between the ages of 3-11
- not primary food shopper
- 7 or more people in household
- inability to collect and submit household food purchase receipts for 22 weeks
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 |
|---|---|---|
| RestrictedCertain foods and beverages are not allowed to be purchased with food benefit dollars. | Behavioural | Restricted |
| Restriction plus IncentiveCertain foods and beverages are not allowed to be purchased with food benefit dollars; 30% of the total dollars spent toward the purchase of certain foods result are added to their food benefit dollars. | Behavioural | Restriction plus Incentive |
Primary outcome
Overall Nutritional Quality as measured by the Healthy Eating Index (HEI)-2015 score
Time frame: 18 weeks
Overall Nutritional Quality obtained from average intake of three dietary recalls at both baseline and follow-up.
3 secondary outcomes
Total Energy Intake
Time frame: 18 weeks
Scores of 3 components (whole fruits, total vegetable, and added sugar) of the HEI-2015
Time frame: 18 weeks
Household food insecurity
Time frame: 18 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 10 Nov 2020.
- Individual participant dataSharing planned: Yes. De-identified data will be placed on the Open Science Framework in compliance with Laura and John Arnold Foundation (LJAF) policies.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restricted and Restriction plus Incentive in people with Nutritional Quality and Food Insecurity, 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 9 inclusion and 8 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 10 Nov 2020. 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?
Overall Nutritional Quality as measured by the Healthy Eating Index (HEI)-2015 score (time frame: 18 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 10 Nov 2020.