Food SelectionNCT04243252
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
A study testing Healthy Pantry Program in people with Food Selection, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Selection
- What is being tested?
- Healthy Pantry Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2020to 12 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- Food Selection
- Being tested
- Healthy Pantry Program, Waitlist Control
- Keywords
- food insecurity
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Pantry ProgramBehavioural
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.
Waitlist ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Food Pantries | Experimental | 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. Receives: Behavioral: Healthy Pantry Program |
| Control Food Pantries | Active comparator | Food pantries will continue to operate as usual during the study period; the effect on pantries and their clients will be measured. Receives: Other: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly change in proportion of green-labeled foods purchased by food pantries from the food bank
Monthly change from baseline values of healthier foods purchased by pantries from the food bank in the proportion of green-labeled foods.
Measured: 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
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)
Measured: Collected from the electronic ordering system at baseline and prospectively each month for 9 months
Secondary outcomes (4)
Change in food availability at food pantries
Change from baseline in food availability score using the Healthy Food Pantry Assessment Tool (range: 0-45, higher scores represent greater food availability)
Measured: Assessed at baseline and 6 months
Change in healthier food selection by pantry clients
Change from baseline in pantry basket inventories of pantry clients measured by the proportion of green-labeled foods for each basket
Measured: Assessed at baseline and 6 months
Change in healthier food selection by pantry clients
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)
Measured: Assessed at baseline and 6 months
Change in self-reported fruit and vegetable intake of pantry clients
Change from baseline fruit and vegetable intake in cup equivalents measured by the Dietary Screener from the California Health Information Survey 2005
Measured: Assessed at baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start5 Mar 2020
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Why it stopped: COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food SelectionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Greater Boston Food Bank
- Responsible party
- Principal investigator, Anne N. Thorndike, MD, MPH, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243252
- Sponsor's protocol ID
- 2019P003211
- Status last verified
- Jun 2021
- First submitted
- 22 Jan 2020
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Pantry Program Intervention Evaluation (HAPPIE)
- ClinicalTrials.gov ID
- NCT04243252
- Acronym / sponsor ID
- 2019P003211
- Conditions
- Food Selection
- Keywords
- food insecurity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID pandemic
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Greater Boston Food Bank
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Food Pantries | Experimental | Behavioral: Healthy Pantry ProgramFood 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. |
| Control Food Pantries | Active comparator | Other: Waitlist ControlFood pantries will continue to operate as usual during the study period; the effect on pantries and their clients will be measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Pantry ProgramFood 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. | Behavioural | Intervention Food Pantries |
| Waitlist ControlNormal 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. | Other | Control Food Pantries |
Primary outcome
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.
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)
4 secondary outcomes
Change in food availability at food pantries
Time frame: Assessed at baseline and 6 months
Change in healthier food selection by pantry clients
Time frame: Assessed at baseline and 6 months
Change in healthier food selection by pantry clients
Time frame: 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
Results and safety
The study was stopped early (reason given: COVID pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Pantry Program in people with Food Selection, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.