- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03421106
A Multilevel Intervention in the Hunger Relief Network to Improve Diet Among Adults Experiencing Food Insecurity (SuperShelf)
May 11, 2022 updated by: Caitlin Caspi, University of Connecticut
The investigator proposes an evaluation of a randomized, sustainable intervention in 8 intervention and 8 control pantries.
We will enroll a sample clients at the food pantry at baseline and follow them for 1 year to assess changes in overall diet quality (the primary outcome) and cardiovascular health.
We will also enroll a sample of clients at follow-up to assess to assess the nutritional quality of food selected at the pantry.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 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.
Study Type
Interventional
Enrollment (Actual)
504
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, 55414
- University of Minnesota
-
-
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
18 years to 99 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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.
|
Normal food pantry use
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Diet Quality of Clients
Time Frame: Baseline, 1 year
|
Assessed by Healthy Eating Index-2015 scores (scale 0-100), with 100 representing the best possible score (i.e., nutritional quality best aligned with Dietary Guidelines for Americans)
|
Baseline, 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutritional Quality of Food Selected by Clients at the Food Pantry
Time Frame: 1 year post-sample comparison
|
Assessed by Healthy Eating Index-2015 scores (scale 0-100), with 100 representing the best possible score (i.e., nutritional quality best aligned with Dietary Guidelines for Americans)
|
1 year post-sample comparison
|
|
Cardiovascular Health
Time Frame: Baseline, 1 year
|
American Heart Association's Life's Simple 7 (LS7) scores (scale 0 -7), with 7 representing the best possible score for cardiovascular health
|
Baseline, 1 year
|
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)
February 5, 2018
Primary Completion (ACTUAL)
September 1, 2019
Study Completion (ACTUAL)
November 16, 2020
Study Registration Dates
First Submitted
January 29, 2018
First Submitted That Met QC Criteria
January 29, 2018
First Posted (ACTUAL)
February 5, 2018
Study Record Updates
Last Update Posted (ESTIMATE)
February 9, 2023
Last Update Submitted That Met QC Criteria
May 11, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H20-0076
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.
Clinical Trials on Food Selection
-
Kathmandu University School of Medical SciencesResolve to Save LivesRecruiting
-
Johns Hopkins Bloomberg School of Public HealthNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University... and other collaboratorsCompleted
-
The University of Hong KongCompleted
-
Stanford UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
Laval UniversityMinistère de l'environnement et lutte contre les changements climatiquesCompleted
-
Massachusetts General HospitalGreater Boston Food BankTerminated
-
University of Paris 13Intitut National du CancerCompleted
-
University of MinnesotaCompletedFood SelectionUnited States
-
University of MinnesotaCompleted
-
University at BuffaloNational Institute on Minority Health and Health Disparities (NIMHD)Active, not recruiting
Clinical Trials on Intervention Food Pantries
-
Johns Hopkins Bloomberg School of Public HealthNational Heart, Lung, and Blood Institute (NHLBI); Oakland UniversityRecruitingImproving Healthy Food Access in Food Insecurity Populations in Normal and Emergency SituationsUnited States
-
Children's Hospital Medical Center, CincinnatiEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingFood InsecurityUnited States
-
Universidad Católica del UruguayNot yet recruitingGlycemic ResponsesUruguay
-
Clinical Nutrition Research Centre, SingaporeCompletedBlood Pressure | Heart Rate | Thermogenesis | Effects of; FoodSingapore
-
Hospices Civils de LyonCompleted
-
Wake Forest University Health SciencesRecruitingType 2 Diabetes Mellitus (T2D)United States
-
Kent State UniversityRhode Island Hospital; University of MemphisTerminatedChild, Only | Allergy;Food | Adherence, TreatmentUnited States
-
University of ArkansasCompletedDiabetes Mellitus, Type 2 | Diet, HealthyUnited States
-
Indiana UniversityCompletedDiabetes MellitusUnited States
-
Laval UniversityCanadian Foundation for Dietetic Research (CFDR)Completed