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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04243252
Other study ID # 2019P003211
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 5, 2020
Est. completion date March 12, 2020

Study information

Verified date June 2021
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The hypothesis is that participation the Healthy Pantry Program will lead to increases in pantry purchases of healthy foods.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date March 12, 2020
Est. primary completion date March 12, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Greater Boston Food Bank

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Collected from the electronic ordering system at baseline and prospectively each month for 9 months
Primary 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) Collected from the electronic ordering system at baseline and prospectively each month for 9 months
Secondary 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) Assessed at baseline and 6 months
Secondary 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 Assessed at baseline and 6 months
Secondary 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) Assessed at baseline and 6 months
Secondary 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 Assessed at baseline and 6 months
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