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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03421106
Acronym
SuperShelf
Enrollment
504
Registered
2018-02-05
Start date
2018-02-05
Completion date
2020-11-16
Last updated
2023-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Selection

Keywords

Food insecurity, Food pantries

Brief 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.

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.

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

Sponsors

University of Connecticut
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall Diet Quality of ClientsBaseline, 1 yearAssessed 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)

Secondary

MeasureTime frameDescription
Nutritional Quality of Food Selected by Clients at the Food Pantry1 year post-sample comparisonAssessed 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)
Cardiovascular HealthBaseline, 1 yearAmerican Heart Association's Life's Simple 7 (LS7) scores (scale 0 -7), with 7 representing the best possible score for cardiovascular health

Countries

United States

Participant flow

Recruitment details

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).

Participants by arm

ArmCount
Intervention Food Pantries and Clients
Food pantries will transform to offer healthier and more appealing food; the effect on clients will be measured; Intervention Food Pantries: Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors; Intervention Clients: Clients who use and were recruited at intervention food pantries.
243
Control Food Pantries and Clients
Food pantries will make no changes during the evaluation period; the effect on clients will be measured; Control Food Pantries: Normal food pantry operations during the evaluation period; Control Clients: Clients who use and were recruited at control food pantries.
261
Total504

Baseline characteristics

CharacteristicIntervention Food Pantries and ClientsControl Food Pantries and ClientsTotal
Age, Customized
18-64
210 Participants227 Participants437 Participants
Age, Customized
65 years and older
31 Participants31 Participants62 Participants
Age, Customized
Less than 18 years
0 Participants0 Participants0 Participants
Age, Customized
Unknown
2 Participants3 Participants5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
20 Participants15 Participants35 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Black or African American
23 Participants56 Participants79 Participants
Race (NIH/OMB)
More than one race
34 Participants19 Participants53 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
19 Participants16 Participants35 Participants
Race (NIH/OMB)
White
146 Participants153 Participants299 Participants
Region of Enrollment
United States
243 Participants261 Participants504 Participants
Sex: Female, Male
Female
146 Participants169 Participants315 Participants
Sex: Female, Male
Male
94 Participants89 Participants183 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 1581 / 159
other
Total, other adverse events
0 / 1580 / 159
serious
Total, serious adverse events
0 / 1580 / 159

Outcome results

Primary

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

Population: COVID-19 disrupted intervention and post-evaluation activities in 5 sites. The analysis includes participants in Sample A at the 11 completed sites.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Intervention Food Pantries and ClientsOverall Diet Quality of Clients1.09 Pre-post change in HEI score on a scaleStandard Error 1.45
Control Food Pantries and ClientsOverall Diet Quality of Clients-1.42 Pre-post change in HEI score on a scaleStandard Error 1.52
p-value: 0.23Mixed Models Analysis
Secondary

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

Population: COVID-19 disrupted intervention and post-evaluation activities in 5 sites. The analysis includes participants in Sample A at the 11 completed sites.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Intervention Food Pantries and ClientsCardiovascular Health-0.09 Pre-post change in LS7 score on a scaleStandard Error 0.15
Control Food Pantries and ClientsCardiovascular Health0.41 Pre-post change in LS7 score on a scaleStandard Error 0.16
Secondary

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

Population: COVID-19 disrupted intervention and post-evaluation activities in 5 sites. The analysis includes participants in Sample B at the 11 completed sites.

ArmMeasureValue (MEAN)Dispersion
Intervention Food Pantries and ClientsNutritional Quality of Food Selected by Clients at the Food Pantry60.6 Post-sample HEI scoreStandard Deviation 11.8
Control Food Pantries and ClientsNutritional Quality of Food Selected by Clients at the Food Pantry64.0 Post-sample HEI scoreStandard Deviation 10

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026