ClinicalTrials.gg
TerminatedNCT03421106SuperShelfUpdated Feb 9, 2023Results posted

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

An interventional study of Intervention Food Pantries and Control Food Pantries in Food Selection, sponsored by University of Connecticut. Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-02-09.

Sponsored by University of Connecticut · Not applicable, Interventional, and Prevention

Why this study was terminated
Data collection was halted prematurely due to COVID-19.

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Phase
Not applicable
Study type
Interventional
Enrollment
504
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 62 studies in Food Preferences with a site in United States — 8 open to participants now, 8 under way, none of them phase 3. Food Preferences · United States.

Enrollment
23rd of 55
504 · median 216
Started
2018
with 4 others
No phase
55 of 62
7 open now
Registered
18th of 62
by date

Among the 62 studies in Food Preferences with a site in United States, this one is the 23rd largest by enrollment of the 55 interventional ones that give a count, is one of 5 that started in 2018, is one of 55 with no phase, and was the 18th registered.

Food Preferences

155 studies on the registry are indexed under Food Preferences; 19 are open to participants now.

Browse Food Preferences studies →

Open to participants now

8 of the 62 studies in Food Preferences with a site in United States are open now. Recruiting first, the newest first:

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All 8 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 15 Food Preferences studies recruiting now, 2 (13%) set no upper age limit and 12 (80%) stop at 75 or younger; 5 take children under 18; 12 take healthy volunteers.

This study: 18 Years to 99 Years · all sexes · no healthy volunteers.

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02

Study summary

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.

Read the 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.

03

Conditions studied

  • Food Selection

Browse trials for

Keywords

  • Food insecurity
  • Food pantries
04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-≥18 years old

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

Exclusion criteria

Exclusion Criteria:

  • Not capable of consent or participation
  • Speak only languages other than English, Spanish or Somali
  • Not a food pantry user
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
504 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralIntervention Food Pantries

    Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors.

  • OtherControl Food Pantries

    Normal food pantry use

06

What researchers measure

Primary outcomes

  1. Overall Diet Quality of Clients

    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)

    Time frame: Baseline, 1 year

Secondary outcomes

  1. Nutritional Quality of Food Selected by Clients at the Food Pantry

    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)

    Time frame: 1 year post-sample comparison

  2. Cardiovascular Health

    American Heart Association's Life's Simple 7 (LS7) scores (scale 0 -7), with 7 representing the best possible score for cardiovascular health

    Time frame: Baseline, 1 year

07

Results

Posted Feb 9, 2023

Participant flow

Two samples of participants were enrolled. The first (Sample A, n=317), had measures collected at two time points. They were enrolled at baseline and followed for one year to assess change in diet quality (primary outcome) and cardiovascular measures (secondary outcome). The second (Sample B, n=187) had measures collected at one time point only. They were enrolled at the pantry during the follow-up period to assess post-intervention client cart diet quality (secondary outcome).

Sample A (Followed for 1 Year)
Participant flow — Sample A (Followed for 1 Year)
MilestoneIntervention Food Pantries and ClientsControl Food Pantries and Clients
Started158159
Completed102105
Not completed5654
Sample B (Evaluated at Post Only)
Participant flow — Sample B (Evaluated at Post Only)
MilestoneIntervention Food Pantries and ClientsControl Food Pantries and Clients
Started85102
Completed85102
Not completed00

Outcome measures

PrimaryOverall Diet Quality of Clients

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)

Time frame:
Baseline, 1 year
Reported as:
Least squares mean · Pre-post change in HEI score on a scale
Overall Diet Quality of Clients
Pre-post change in HEI score on a scaleIntervention Food Pantries and ClientsControl Food Pantries and Clients
Overall Diet Quality of Clients1.09 ± 1.45-1.42 ± 1.52
Statistical analysis
  • Intervention Food Pantries and Clients vs Control Food Pantries and Clients · Mixed Models Analysis · p = 0.23 · Mean difference (net): 2.53
SecondaryNutritional Quality of Food Selected by Clients at the Food Pantry

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)

Time frame:
1 year post-sample comparison
Reported as:
Mean · Post-sample HEI score
Nutritional Quality of Food Selected by Clients at the Food Pantry
Post-sample HEI scoreIntervention Food Pantries and ClientsControl Food Pantries and Clients
Nutritional Quality of Food Selected by Clients at the Food Pantry60.6 ± 11.864.0 ± 10
SecondaryCardiovascular Health

American Heart Association's Life's Simple 7 (LS7) scores (scale 0 -7), with 7 representing the best possible score for cardiovascular health

Time frame:
Baseline, 1 year
Reported as:
Least squares mean · Pre-post change in LS7 score on a scale
Cardiovascular Health
Pre-post change in LS7 score on a scaleIntervention Food Pantries and ClientsControl Food Pantries and Clients
Cardiovascular Health-0.09 ± 0.150.41 ± 0.16

Adverse events

Collected over Adverse events were collected during the period of follow-up for each participant. In Sample A, the mean follow-up was 13.9 months. In Sample B, there was no follow-up and no monitoring of adverse events.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention Food Pantries and Clients1/158 (0.6%)0/158 (0%)0/158 (0%)
Control Food Pantries and Clients1/159 (0.6%)0/159 (0%)0/159 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Participants)Intervention Food Pantries and ClientsControl Food Pantries and ClientsTotal
Less than 18 years000
18-64210227437
65 years and older313162
Unknown235
Sex: Female, Male
Sex: Female, Male(Participants)Intervention Food Pantries and ClientsControl Food Pantries and ClientsTotal
Female146169315
Male9489183
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intervention Food Pantries and ClientsControl Food Pantries and ClientsTotal
American Indian or Alaska Native201535
Asian022
Native Hawaiian or Other Pacific Islander101
Black or African American235679
White146153299
More than one race341953
Unknown or Not Reported191635
Region of Enrollment
Region of Enrollment(Participants)Intervention Food Pantries and ClientsControl Food Pantries and ClientsTotal
United States243261504
08

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55414, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Sep 2019, 18 months.

Results were first posted in Feb 2023, 3 years 5 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2018
First posted
Feb 5, 2018
StartActual
Feb 5, 2018
Primary completionActual
Sep 1, 2019
CompletionActual
Nov 16, 2020
Results first posted
Feb 9, 2023
Last update
Feb 9, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03421106
Responsible party
Caitlin Caspi (Associate Professor, University of Connecticut) — Principal investigator
First posted
Feb 5, 2018
Start date
Feb 5, 2018
Primary completion
Sep 1, 2019
Completion
Nov 16, 2020
Results posted
Feb 9, 2023
Last update
Feb 9, 2023

Study contacts

Caitlin E Caspi, ScD
principal investigator · University of Connecticut

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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