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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

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ClinicalTrials.gov Identifier: NCT04243252
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : June 24, 2020
Sponsor:
Collaborator:
Greater Boston Food Bank
Information provided by (Responsible Party):
Anne N. Thorndike, MD, MPH, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Food Selection Behavioral: Healthy Pantry Program Other: Waitlist Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Healthy Pantry Program Intervention Evaluation (HAPPIE)
Actual Study Start Date : March 5, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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)

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243252


Contacts
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Contact: Jenny Jia, MD, MSc 6177247720 jjia1@mgh.harvard.edu
Contact: Anne N Thorndike, MD, MPH 6177244608 athorndike@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jenny Jia, MD, MSc    617-724-7720    jjia1@mgh.harvard.edu   
Contact: Anne Thorndike, MD, MPH    6177244608    athorndike@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Greater Boston Food Bank
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Responsible Party: Anne N. Thorndike, MD, MPH, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04243252    
Other Study ID Numbers: 2019P003211
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anne N. Thorndike, MD, MPH, Massachusetts General Hospital:
food insecurity