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Grocery Assistance Program Study for Families

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363048
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE November 29, 2017
First Posted Date  ICMJE December 5, 2017
Last Update Posted Date November 10, 2020
Actual Study Start Date  ICMJE May 2, 2018
Actual Primary Completion Date October 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Grocery Assistance Program Study for Families
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Nutritional Quality
  • Food Insecurity
  • Food Legislation
  • Healthy Diet
  • Food Stamp Program
Intervention  ICMJE
  • 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  ICMJE
  • Experimental: Restricted
    Intervention: Behavioral: Restricted
  • Experimental: Restriction plus Incentive
    Intervention: Behavioral: Restriction plus Incentive
  • No Intervention: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2019)
646
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2017)
480
Actual Study Completion Date  ICMJE October 6, 2019
Actual Primary Completion Date October 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03363048
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Minnesota
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP