- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04243252
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
Healthy Pantry Program Intervention Evaluation (HAPPIE)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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.
|
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.
|
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
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019P003211
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
Kathmandu University School of Medical SciencesResolve to Save LivesRecruiting
-
Johns Hopkins Bloomberg School of Public HealthNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University... and other collaboratorsCompleted
-
The University of Hong KongCompleted
-
Stanford UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
Laval UniversityMinistère de l'environnement et lutte contre les changements climatiquesCompleted
-
University of Paris 13Intitut National du CancerCompleted
-
University of MinnesotaCompletedFood SelectionUnited States
-
University of MinnesotaCompleted
-
University at BuffaloNational Institute on Minority Health and Health Disparities (NIMHD)Active, not recruiting
-
Yale UniversityHispanic Health Council, Inc.; Wholesome WaveCompletedFood Insecurity | Food Preferences | Food SelectionUnited States
Clinical Trials on Healthy Pantry Program
-
Wabanaki Public Health and WellnessYale University; Washington State University; Drexel UniversityRecruitingFood InsecurityUnited States
-
Montana State UniversityCenter for American Indian and Rural Health Equity; Gallatin Valley Food Bank; Livingston Food Resource Center and other collaboratorsCompletedHealth Behavior | Diet, Healthy | Disease, Chronic | Diet Habit | Rural HealthUnited States
-
Human Development Research Foundation, PakistanUniversity of Liverpool; Shifa Tameer-e-Millat UniversityCompletedDepression, Postpartum | Perinatal DepressionPakistan
-
University of Alabama, TuscaloosaNational Institute of Mental Health (NIMH)RecruitingDepressive Symptoms | Anxiety SymptomsUnited States
-
The University of Texas at ArlingtonUniversity of South Florida; Center for Transportation, Equity, Decisions and...CompletedLack of Resources | Lack of MobilityUnited States
-
University of British ColumbiaPublic Health Agency of Canada (PHAC); The Bridge Youth and Family Services...CompletedOverweight and Obesity | Health Knowledge, Attitudes, PracticeCanada
-
University of UtahNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruiting
-
University of Central FloridaDepartment of Health and Human ServicesCompleted
-
University of Texas Southwestern Medical CenterCompletedCancer | Diet, Healthy | Nutrition, HealthyUnited States
-
Oklahoma State University Center for Health SciencesUniversity of Oklahoma; Osage NationCompletedBlood Pressure | Food Insecurity | Overweight or Obesity | Diet, Healthy | Health StatusUnited States