Grocery Assistance Program Study for Families

• ClinicalTrials.gov Identifier: NCT03363048
• Recruitment Status: Completed
• First Posted: December 5, 2017
• Last Update Posted: November 10, 2020
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Tracking Information

• First Submitted Date: November 29, 2017
• First Posted Date: December 5, 2017
• Last Update Posted Date: November 10, 2020
• Actual Study Start Date: May 2, 2018
• Actual Primary Completion Date: October 6, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 29, 2017)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 13, 2017)

• 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 ]

Original Secondary Outcome Measures (submitted: November 29, 2017)

• Total Energy Intake [ Time Frame: 18 weeks ]
• Scores of each of the 13 components of the HEI-2015 [ Time Frame: 18 weeks ]
• Household food purchasing [ Time Frame: 18 weeks ]
• Household food insecurity [ Time Frame: 18 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Grocery Assistance Program Study for Families
• Official Title: Effects of Subsidies and Prohibitions on Household Nutrition in a Food Benefit Program
• Brief 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 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Nutritional Quality
• Food Insecurity
• Food Legislation
• Healthy Diet
• Food Stamp Program

Intervention

• Behavioral: Restricted
  Certain foods and beverages are not allowed to be purchased with food benefit dollars.
• Behavioral: 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.

Study Arms

• Experimental: Restricted
  Intervention: Behavioral: Restricted
• Experimental: Restriction plus Incentive
  Intervention: Behavioral: Restriction plus Incentive
• No Intervention: Control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 22, 2019): 646
• Original Estimated Enrollment (submitted: November 29, 2017): 480
• Actual Study Completion Date: October 6, 2019
• Actual Primary Completion Date: October 6, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03363048
• Other Study ID Numbers: STUDY00002037
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: De-identified data will be placed on the Open Science Framework in compliance with Laura and John Arnold Foundation (LJAF) policies.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Analytic Code
• Time Frame: Data will be made available upon publication of the primary outcomes manuscript and will be posted indefinitely.
• URL: https://osf.io/

• Responsible Party: University of Minnesota
• Study Sponsor: University of Minnesota
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Minnesota
• Verification Date: November 2020