A Trial of Traffic Light Labeling With Behavioral Nudges and a Healthy Recipe Database to Increase Selection of Healthier Foods in Client-choice Food Pantries

June 15, 2021 updated by: Anne N. Thorndike, MD, MPH, Massachusetts General Hospital

Healthy Pantry Program Intervention Evaluation (HAPPIE)

This study is a pilot evaluation of the Healthy Pantry Program, a new behavioral economics-based training that allows pantry staff to learn how to implement nudges integrating traffic-light nutrition labeling and a healthy recipe database in the pantry environment. The hypothesis is that participation the Healthy Pantry Program will lead to increases in pantry purchases of healthy foods.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Food insecurity affects more than one in 10 Americans and is associated with poor nutrition and adverse health outcomes, including diabetes, hypertension, and mental health issues. Many food-insecure individuals use food pantries, which provide charitable food, to supplement household food needs. The emergence of client-choice food pantries, where individuals can select the foods they take home, provides a novel opportunity to intervene on the diets of food pantry clients.

This study evaluates the Healthy Pantry Program (HPP) in a sample of 10 food pantries in the greater Boston area. Pantries will be matched on baseline characteristics and randomized 1:1 into participation in HPP (intervention) or wait list (control). Outcomes data will be collected at the pantry and client level. The aims of the study are as follows:

Aim 1: To evaluate whether HPP is associated with increased healthy food purchases from the food bank by intervention food pantries compared to control food pantries.

Aim 2: To evaluate whether HPP is associated with increases in the availability of healthy food in intervention food pantries compared to control food pantries.

Aim 3: To evaluate whether HPP is associated with an increase in healthy food selection and dietary intake by clients of intervention food pantries compared to clients of control food pantries, using a cross-sectional sample of 400 food pantry clients at baseline and 400 food pantry clients at 6-month follow up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Pantry Inclusion Criteria:

  • maximum client-choice (clients can choose all items that they take from pantry)
  • operate at least once weekly
  • affiliated with the Greater Boston Food Bank

Pantry Exclusion Criteria:

  • not affiliated with the Greater Boston Food Bank
  • operating less than once weekly
  • not a maximum client-choice food pantry
  • >1 hr drive from Boston
  • <50 clients on average per open day

Client Inclusion Criteria (for cross-sectional surveys at baseline and 6-month follow up):

  • ≥18 years old
  • pantry client
  • speaks English or Spanish

Client Exclusion Criteria:

  • <18 years old
  • does not speak English or Spanish

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Food Pantries
Food pantries will complete online training to help them rank foods by nutritional value and promote those foods to pantry clients; the effect on pantries and their clients will be measured.
Behavioral: Healthy Pantry Program
Food pantries will receive the Healthy Pantry Program online training, which will be completed by at least one pantry staff member and teaches pantry staff a novel traffic-light nutrition labeling system, a multilingual healthy recipe database, and how to use those and other behavioral economic strategies to implement simple interventions in the food pantry to promote client selection of healthier options. Onsite support by a registered dietitian is included.
Active Comparator: Control Food Pantries
Food pantries will continue to operate as usual during the study period; the effect on pantries and their clients will be measured.
Other: Waitlist Control
Normal food pantry use for duration of the 9-month study period. Control pantries will have access to the Healthy Pantry Program after study is completed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Monthly change in proportion of green-labeled foods purchased by food pantries from the food bank
Time Frame: Collected from the electronic ordering system at baseline and prospectively each month for 9 months
Monthly change from baseline values of healthier foods purchased by pantries from the food bank in the proportion of green-labeled foods.
Collected from the electronic ordering system at baseline and prospectively each month for 9 months
Monthly change in the Healthy Purchasing Score of foods purchased by food pantries from the food bank
Time Frame: Collected from the electronic ordering system at baseline and prospectively each month for 9 months
Monthly change from baseline values of healthier foods purchased by pantries from the food bank in a weighted Healthy Purchasing Score that includes all foods (range: 0-1, higher scores represent healthier selection)
Collected from the electronic ordering system at baseline and prospectively each month for 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in food availability at food pantries
Time Frame: Assessed at baseline and 6 months
Change from baseline in food availability score using the Healthy Food Pantry Assessment Tool (range: 0-45, higher scores represent greater food availability)
Assessed at baseline and 6 months
Change in healthier food selection by pantry clients
Time Frame: Assessed at baseline and 6 months
Change from baseline in pantry basket inventories of pantry clients measured by the proportion of green-labeled foods for each basket
Assessed at baseline and 6 months
Change in healthier food selection by pantry clients
Time Frame: Assessed at baseline and 6 months
Change from baseline in pantry basket inventories of pantry clients measured by Healthy Purchasing Score for each basket (range: 0-1, higher scores represent healthier selection)
Assessed at baseline and 6 months
Change in self-reported fruit and vegetable intake of pantry clients
Time Frame: Assessed at baseline and 6 months
Change from baseline fruit and vegetable intake in cup equivalents measured by the Dietary Screener from the California Health Information Survey 2005
Assessed at baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Greater Boston Food Bank

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019P003211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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

Clinical Trials on Healthy Pantry Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings