Trial Outcomes & Findings for A Trial of Behavioral Economic Interventions Among Food Pantry Clients (NCT NCT04011384)
NCT ID: NCT04011384
Last Updated: 2024-02-29
Results Overview
Average monthly change from baseline across 3 months of participation, in number of units of healthier foods (labeled with a green traffic light) purchased per shopping trip using the food pantry's definition of a unit.
COMPLETED
NA
286 participants
Collected from the online system at baseline and then each month for the remaining 3 months of participation.
2024-02-29
Participant Flow
Participants were clients at a food pantry and were recruited either in-person at the pantry or by phone (after March 2020 due to the Covid-19 pandemic). Recruitment ran from July 2019 to September 2022. 70% of participants were recruited before the pandemic.
Due to the Covid-19 pandemic, we lost 47 participants who were consented (before March 2020), but had not yet completed their baseline appointment. 3 others were accidentally enrolled, but did not meet our enrollment criteria and were excluded before baseline. Finally 1 was excluded because they were not randomized to a condition.
Participant milestones
| Measure |
Control Group
Participants in this arm will view the typical web-based ordering system platform (usual care group).
|
Behavioral Economic Intervention Group
Participants in this arm will be exposed to the web-based ordering system with multiple behavioral economic interventions applied, including healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
Behavioral economic intervention of online purchasing at a food pantry: This intervention includes multiple behavioral economic interventions, healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
124
|
|
Overall Study
COMPLETED
|
109
|
124
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Control Group
Participants in this arm will view the typical web-based ordering system platform (usual care group).
|
Behavioral Economic Intervention Group
Participants in this arm will be exposed to the web-based ordering system with multiple behavioral economic interventions applied, including healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
Behavioral economic intervention of online purchasing at a food pantry: This intervention includes multiple behavioral economic interventions, healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
A Trial of Behavioral Economic Interventions Among Food Pantry Clients
Baseline characteristics by cohort
| Measure |
Control Group
n=109 Participants
Participants in this arm will view the typical web-based ordering system platform (usual care group).
|
Behavioral Economic Intervention Group
n=124 Participants
Participants in this arm will be exposed to the web-based ordering system with multiple behavioral economic interventions applied, including healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
Behavioral economic intervention of online purchasing at a food pantry: This intervention includes multiple behavioral economic interventions, healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 12 • n=5 Participants
|
66 years
STANDARD_DEVIATION 15 • n=7 Participants
|
66 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
105 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Language
English
|
50 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Language
Russian
|
56 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Language
Other language
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Education
Less than high school
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Education
High school degree or equivalent
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Education
Some college or associates
|
24 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Education
College or above
|
49 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Education
Unknown
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Children at home
No children at home
|
87 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Children at home
1 or more children at home
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Children at home
Unknown
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Collected from the online system at baseline and then each month for the remaining 3 months of participation.Population: Some participants were missing order data -- especially near March 2020 at the start of the Covid-19 pandemic.
Average monthly change from baseline across 3 months of participation, in number of units of healthier foods (labeled with a green traffic light) purchased per shopping trip using the food pantry's definition of a unit.
Outcome measures
| Measure |
Behavioral Economic Intervention Group
n=107 Participants
Participants in this arm will be exposed to the web-based ordering system with multiple behavioral economic interventions applied, including healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
Behavioral economic intervention of online purchasing at a food pantry: This intervention includes multiple behavioral economic interventions, healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
|
Control Group
n=99 Participants
Participants in this arm will view the typical web-based ordering system platform (usual care group).
|
|---|---|---|
|
Mean Monthly Change in Number of Units of Healthier Foods
|
0.53 units of healthy food
Standard Deviation 5.54
|
-1.32 units of healthy food
Standard Deviation 7.77
|
PRIMARY outcome
Timeframe: Collected from the online system at baseline and then each month for the remaining 3 months of participation.Population: Some participants were missing order data -- especially near March 2020 at the start of the Covid-19 pandemic.
Average monthly change from baseline across 3 months of participation, in number of units of less healthy foods (labeled with a red or yellow traffic light) purchased per shopping trip using the food pantry's definition of a unit.
Outcome measures
| Measure |
Behavioral Economic Intervention Group
n=107 Participants
Participants in this arm will be exposed to the web-based ordering system with multiple behavioral economic interventions applied, including healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
Behavioral economic intervention of online purchasing at a food pantry: This intervention includes multiple behavioral economic interventions, healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
|
Control Group
n=99 Participants
Participants in this arm will view the typical web-based ordering system platform (usual care group).
|
|---|---|---|
|
Mean Monthly Change in Number of Units of Less Healthy Foods
|
-0.04 units of less healthy food
Standard Deviation 2.68
|
0.20 units of less healthy food
Standard Deviation 3.67
|
SECONDARY outcome
Timeframe: Collected from the online system at baseline and then each month for the remaining 3 months of participation.Population: Some participants were missing order data -- especially near March 2020 at the start of the Covid-19 pandemic.
Average monthly change from baseline across 3 months of participation, in number of calories from healthier foods per shopping trip.
Outcome measures
| Measure |
Behavioral Economic Intervention Group
n=107 Participants
Participants in this arm will be exposed to the web-based ordering system with multiple behavioral economic interventions applied, including healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
Behavioral economic intervention of online purchasing at a food pantry: This intervention includes multiple behavioral economic interventions, healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
|
Control Group
n=99 Participants
Participants in this arm will view the typical web-based ordering system platform (usual care group).
|
|---|---|---|
|
Mean Monthly Change in Calories From Healthier Foods Per Shopping Trip
|
31 calories from healthy food
Standard Deviation 581
|
-124 calories from healthy food
Standard Deviation 694
|
SECONDARY outcome
Timeframe: Collected from the online system at baseline and then each month for the remaining 3 months of participation.Population: Some participants were missing order data -- especially near March 2020 at the start of the Covid-19 pandemic.
Average monthly change from baseline across 3 months of participation, in number of calories from less healthy foods per shopping trip.
Outcome measures
| Measure |
Behavioral Economic Intervention Group
n=107 Participants
Participants in this arm will be exposed to the web-based ordering system with multiple behavioral economic interventions applied, including healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
Behavioral economic intervention of online purchasing at a food pantry: This intervention includes multiple behavioral economic interventions, healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
|
Control Group
n=99 Participants
Participants in this arm will view the typical web-based ordering system platform (usual care group).
|
|---|---|---|
|
Mean Monthly Change in Calories From Less Healthy Foods Per Shopping Trip
|
14 calories from less healthy food
Standard Deviation 472
|
29 calories from less healthy food
Standard Deviation 545
|
SECONDARY outcome
Timeframe: Assessed at baseline and 3 months.Population: Some participants were missing survey data -- especially near March 2020 at the start of the Covid-19 pandemic.
Change from baseline in fruit and vegetable intake as measured by the National Cancer Institute (NCI)'s fruit and vegetable module of the Dietary Screener Questionnaire in the National Health and Nutrition Examination Survey (NHANES). Scores estimate average daily cup equivalents of total fruit and vegetable servings.
Outcome measures
| Measure |
Behavioral Economic Intervention Group
n=109 Participants
Participants in this arm will be exposed to the web-based ordering system with multiple behavioral economic interventions applied, including healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
Behavioral economic intervention of online purchasing at a food pantry: This intervention includes multiple behavioral economic interventions, healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
|
Control Group
n=97 Participants
Participants in this arm will view the typical web-based ordering system platform (usual care group).
|
|---|---|---|
|
Self-reported Change in Fruit and Vegetable Intake
|
0.08 cup equivalents/day
Standard Deviation 1.32
|
-0.01 cup equivalents/day
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Assessed at baseline and 3 months.Population: Many participants were unable to complete the 2nd in-person data collection due to Covid-19
Change from baseline in carotenoid levels (scores range 0-800) as measured by the VeggieMeter®. The VeggieMeter® is a spectroscopy-based skin carotenoid measurement device, created by Longevity Link Corporation in 2015. It uses pressure-mediated reflection spectroscopy (RS) to detect and quantify skin carotenoids as a proxy for fruit and vegetable intake in humans. Validation studies show VeggieMeter scores to be highly correlated with blood serum measures of carotenoids (R=.81). Higher units represent a higher concentration of carotenoids in the skin.
Outcome measures
| Measure |
Behavioral Economic Intervention Group
n=60 Participants
Participants in this arm will be exposed to the web-based ordering system with multiple behavioral economic interventions applied, including healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
Behavioral economic intervention of online purchasing at a food pantry: This intervention includes multiple behavioral economic interventions, healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
|
Control Group
n=53 Participants
Participants in this arm will view the typical web-based ordering system platform (usual care group).
|
|---|---|---|
|
Biomarker Change in Fruit and Vegetable Intake
|
4 skin carotenoid score
Standard Deviation 113
|
11 skin carotenoid score
Standard Deviation 113
|
SECONDARY outcome
Timeframe: Assessed at baseline and 3 months.Population: Several participants were not able to do the follow-up in-person measures due to the Covid-19 pandemic
Change from baseline in BMI (weight in kg / height in meters\^2)
Outcome measures
| Measure |
Behavioral Economic Intervention Group
n=69 Participants
Participants in this arm will be exposed to the web-based ordering system with multiple behavioral economic interventions applied, including healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
Behavioral economic intervention of online purchasing at a food pantry: This intervention includes multiple behavioral economic interventions, healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
|
Control Group
n=66 Participants
Participants in this arm will view the typical web-based ordering system platform (usual care group).
|
|---|---|---|
|
Change in Body Mass Index (BMI)
|
-0.12 kilograms per square meter
Standard Deviation 1.48
|
-0.11 kilograms per square meter
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: Assessed at baseline and 3 months.Population: Several participants were not able to complete the follow-up in-person appointments due to the Covid-19 pandemic.
Change from baseline in systolic blood pressure (indicator of heart health)
Outcome measures
| Measure |
Behavioral Economic Intervention Group
n=69 Participants
Participants in this arm will be exposed to the web-based ordering system with multiple behavioral economic interventions applied, including healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
Behavioral economic intervention of online purchasing at a food pantry: This intervention includes multiple behavioral economic interventions, healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
|
Control Group
n=66 Participants
Participants in this arm will view the typical web-based ordering system platform (usual care group).
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
0.1 mmHg
Standard Deviation 16.5
|
5.3 mmHg
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: Assessed at baseline and 3 months.Population: Several participants were not able to make it to their follow-up in-person appointment due to the Covid-19 pandemic.
Change from baseline in diastolic blood pressure (indicator of heart health)
Outcome measures
| Measure |
Behavioral Economic Intervention Group
n=69 Participants
Participants in this arm will be exposed to the web-based ordering system with multiple behavioral economic interventions applied, including healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
Behavioral economic intervention of online purchasing at a food pantry: This intervention includes multiple behavioral economic interventions, healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
|
Control Group
n=66 Participants
Participants in this arm will view the typical web-based ordering system platform (usual care group).
|
|---|---|---|
|
Change in Diastolic Blood Pressure
|
-0.3 mmHg
Standard Deviation 9.0
|
2.5 mmHg
Standard Deviation 11.0
|
Adverse Events
Control Group
Behavioral Economic Intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place