A Multilevel Intervention in the Hunger Relief Network to Improve Diet Among Adults Experiencing Food Insecurity (SuperShelf)

• ClinicalTrials.gov Identifier: NCT03421106
• Recruitment Status: Terminated
• First Posted: February 5, 2018
• Last Update Posted: January 15, 2021
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

Brief Summary:

The investigator proposes an evaluation of a randomized, sustainable intervention in 8 intervention and 8 control pantries. We will enroll 272 clients at baseline and follow them for 1 year to assess changes in overall diet quality (the primary outcome).

Condition or disease	Intervention/treatment	Phase
Food Selection	Behavioral: Intervention Food Pantries; Other: Control Food Pantries	Not Applicable

Detailed Description:

Evaluate the health impact of an intervention targeting the hunger relief network and the clients with food insecurity it serves. The long-term goal of this work is to reduce nutrition-related health disparities by intervening on a system that serves individuals at high risk for chronic disease. In 2014, an estimated 14% of U.S. households experienced food insecurity (i.e., they lacked access to enough food for an active, healthy life for all household members). Large numbers of low-income, racial/ethnic minority, and immigrant families who experience food insecurity rely on a hunger relief network that includes food banks and food pantries. Pantry clients have demonstrated poor nutritional outcomes, high chronic disease rates, and dissatisfaction with the quality and cultural-appropriateness of food offered. Unlike other food assistance programs, there are currently no standards on the nutritional quality of pantry offerings, but recent work by our study team demonstrated the need to improve the healthfulness of hunger relief network inventory. We proposed an evaluation of a randomized, sustainable intervention in 8 intervention and 8 control pantries. We will enroll 272 clients at baseline and follow them for 1 year to assess changes in overall diet quality (the primary outcome). Working with our food bank partners, the intervention at the pantry level targets the supply of nutritious foods. At the client level, the intervention targets healthy food demand. Measured outcomes include overall diet quality (the primary outcome), as assessed by the Healthy Eating Index-2015 (HEI), the nutritional quality of foods selected at the food shelf visit, and cardiovascular disease health (assessed by the American Heart Association's Life's Simple 7 scores). The study will also evaluate the impact of a multilevel intervention on the nutritional quality of pantry offerings. The study also aims to improve implementation of practices that promote a nutrition-focused hunger relief network, as assessed by survey and key informant interviews. As an exploratory aim, the study will evaluate the cultural appropriateness of pantry foods and services, given the burden of poor food access on minority, immigrant, and refugee families.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 504 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Multilevel Intervention in the Hunger Relief Network to Improve Diet Among Adults Experiencing Food Insecurity
• Actual Study Start Date: February 5, 2018
• Actual Primary Completion Date: September 1, 2019
• Actual Study Completion Date: November 16, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention Food Pantries; Food pantries will transform to offer healthier and more appealing food ; the effect on clients will be measured.	Behavioral: Intervention Food Pantries; Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors.
Active Comparator: Control Food Pantries; Food pantries will make no changes during the evaluation period; the effect on clients will be measured.	Other: Control Food Pantries; Normal food pantry use

Outcome Measures

Primary Outcome Measures :

1. Overall diet quality of clients [ Time Frame: Baseline, 1 year ]
   Assessed by Healthy Eating Index-2015 scores (scale 0-100), with 100 representing the highest possible score.

Secondary Outcome Measures :

1. Nutritional quality of food selected by clients at the food pantry [ Time Frame: Baseline, 1 year ]
   Assessed by Healthy Eating Index-2015 scores (scale 0-100), with 100 representing the highest possible score.
2. Cardiovascular health [ Time Frame: Baseline, 1 year ]
   American Heart Association's Life's Simple 7 (LS7) scores (scale 0 -7), with 7 representing the highest possible score

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

-≥18 years old

• Mentally capable of consent and participation
• Speak English, Spanish, or Somali
• Have access to a phone

Exclusion Criteria:

• Not capable of consent or participation
• Speak only languages other than English, Spanish or Somali
• Not a food pantry user

Contacts and Locations

Locations

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55414

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Caitlin E Caspi, ScD; University of Connecticut

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03421106
• Other Study ID Numbers: STUDY00002781
• First Posted: February 5, 2018
• Last Update Posted: January 15, 2021
• Last Verified: January 2021

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

Keywords provided by University of Minnesota:

Food insecurity; Food pantries