- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03363048
Grocery Assistance Program Study for Families
November 9, 2020 updated by: University of Minnesota
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
646
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55454
- University of Minnesota, School of Public Health, Division of Epidemiology & Community Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Restricted
|
Certain foods and beverages are not allowed to be purchased with food benefit dollars.
|
|
Experimental: Restriction plus Incentive
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total Energy Intake
Time Frame: 18 weeks
|
18 weeks
|
|
Scores of 3 components (whole fruits, total vegetable, and added sugar) of the HEI-2015
Time Frame: 18 weeks
|
18 weeks
|
|
Household food insecurity
Time Frame: 18 weeks
|
18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2018
Primary Completion (Actual)
October 6, 2019
Study Completion (Actual)
October 6, 2019
Study Registration Dates
First Submitted
November 29, 2017
First Submitted That Met QC Criteria
November 29, 2017
First Posted (Actual)
December 5, 2017
Study Record Updates
Last Update Posted (Actual)
November 10, 2020
Last Update Submitted That Met QC Criteria
November 9, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00002037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified data will be placed on the Open Science Framework in compliance with Laura and John Arnold Foundation (LJAF) policies.
IPD Sharing Time Frame
Data will be made available upon publication of the primary outcomes manuscript and will be posted indefinitely.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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