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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03363048
Other study ID # STUDY00002037
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2, 2018
Est. completion date October 6, 2019

Study information

Verified date November 2020
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 646
Est. completion date October 6, 2019
Est. primary completion date October 6, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States University of Minnesota, School of Public Health, Division of Epidemiology & Community Health Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 18 weeks
Secondary Total Energy Intake 18 weeks
Secondary Scores of 3 components (whole fruits, total vegetable, and added sugar) of the HEI-2015 18 weeks
Secondary Household food insecurity 18 weeks
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