Trial Outcomes & Findings for A Multilevel Intervention in the Hunger Relief Network to Improve Diet Among Adults Experiencing Food Insecurity (NCT NCT03421106)
NCT ID: NCT03421106
Last Updated: 2023-02-09
Results Overview
Assessed by Healthy Eating Index-2015 scores (scale 0-100), with 100 representing the best possible score (i.e., nutritional quality best aligned with Dietary Guidelines for Americans)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
504 participants
Primary outcome timeframe
Baseline, 1 year
Results posted on
2023-02-09
Participant Flow
Two samples of participants were enrolled. The first (Sample A, n=317), had measures collected at two time points. They were enrolled at baseline and followed for one year to assess change in diet quality (primary outcome) and cardiovascular measures (secondary outcome). The second (Sample B, n=187) had measures collected at one time point only. They were enrolled at the pantry during the follow-up period to assess post-intervention client cart diet quality (secondary outcome).
Participant milestones
| Measure |
Intervention Food Pantries and Clients
Food pantries will transform to offer healthier and more appealing food; the effect on clients will be measured;
Intervention Food Pantries: Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors.
Intervention Clients: Clients who use and were recruited at intervention food pantries.
|
Control Food Pantries and Clients
Food pantries will make no changes during the evaluation period; the effect on clients will be measured.
Control Food Pantries: Normal food pantry operations during the evaluation period.
Control Clients: Clients who use and were recruited at control food pantries.
|
|---|---|---|
|
Sample A (Followed for 1 Year)
STARTED
|
158
|
159
|
|
Sample A (Followed for 1 Year)
COMPLETED
|
102
|
105
|
|
Sample A (Followed for 1 Year)
NOT COMPLETED
|
56
|
54
|
|
Sample B (Evaluated at Post Only)
STARTED
|
85
|
102
|
|
Sample B (Evaluated at Post Only)
COMPLETED
|
85
|
102
|
|
Sample B (Evaluated at Post Only)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
6 total participants did not provide binary sex designations.
Baseline characteristics by cohort
| Measure |
Intervention Food Pantries and Clients
n=243 Participants
Food pantries will transform to offer healthier and more appealing food; the effect on clients will be measured;
Intervention Food Pantries: Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors;
Intervention Clients: Clients who use and were recruited at intervention food pantries.
|
Control Food Pantries and Clients
n=261 Participants
Food pantries will make no changes during the evaluation period; the effect on clients will be measured;
Control Food Pantries: Normal food pantry operations during the evaluation period;
Control Clients: Clients who use and were recruited at control food pantries.
|
Total
n=504 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Less than 18 years
|
0 Participants
n=243 Participants
|
0 Participants
n=261 Participants
|
0 Participants
n=504 Participants
|
|
Age, Customized
18-64
|
210 Participants
n=243 Participants
|
227 Participants
n=261 Participants
|
437 Participants
n=504 Participants
|
|
Age, Customized
65 years and older
|
31 Participants
n=243 Participants
|
31 Participants
n=261 Participants
|
62 Participants
n=504 Participants
|
|
Age, Customized
Unknown
|
2 Participants
n=243 Participants
|
3 Participants
n=261 Participants
|
5 Participants
n=504 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=240 Participants • 6 total participants did not provide binary sex designations.
|
169 Participants
n=258 Participants • 6 total participants did not provide binary sex designations.
|
315 Participants
n=498 Participants • 6 total participants did not provide binary sex designations.
|
|
Sex: Female, Male
Male
|
94 Participants
n=240 Participants • 6 total participants did not provide binary sex designations.
|
89 Participants
n=258 Participants • 6 total participants did not provide binary sex designations.
|
183 Participants
n=498 Participants • 6 total participants did not provide binary sex designations.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
20 Participants
n=243 Participants
|
15 Participants
n=261 Participants
|
35 Participants
n=504 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=243 Participants
|
2 Participants
n=261 Participants
|
2 Participants
n=504 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=243 Participants
|
0 Participants
n=261 Participants
|
1 Participants
n=504 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=243 Participants
|
56 Participants
n=261 Participants
|
79 Participants
n=504 Participants
|
|
Race (NIH/OMB)
White
|
146 Participants
n=243 Participants
|
153 Participants
n=261 Participants
|
299 Participants
n=504 Participants
|
|
Race (NIH/OMB)
More than one race
|
34 Participants
n=243 Participants
|
19 Participants
n=261 Participants
|
53 Participants
n=504 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=243 Participants
|
16 Participants
n=261 Participants
|
35 Participants
n=504 Participants
|
|
Region of Enrollment
United States
|
243 Participants
n=243 Participants
|
261 Participants
n=261 Participants
|
504 Participants
n=504 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 yearPopulation: COVID-19 disrupted intervention and post-evaluation activities in 5 sites. The analysis includes participants in Sample A at the 11 completed sites.
Assessed by Healthy Eating Index-2015 scores (scale 0-100), with 100 representing the best possible score (i.e., nutritional quality best aligned with Dietary Guidelines for Americans)
Outcome measures
| Measure |
Intervention Food Pantries and Clients
n=89 Participants
Food pantries will transform to offer healthier and more appealing food; the effect on clients will be measured;
Intervention Food Pantries: Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors;
Intervention Clients: Clients who use and were recruited at intervention food pantries.
|
Control Food Pantries and Clients
n=104 Participants
Food pantries will make no changes during the evaluation period; the effect on clients will be measured;
Control Food Pantries: Normal food pantry operations during the evaluation period;
Control Clients: Clients who use and were recruited at control food pantries.
|
|---|---|---|
|
Overall Diet Quality of Clients
|
1.09 Pre-post change in HEI score on a scale
Standard Error 1.45
|
-1.42 Pre-post change in HEI score on a scale
Standard Error 1.52
|
SECONDARY outcome
Timeframe: 1 year post-sample comparisonPopulation: COVID-19 disrupted intervention and post-evaluation activities in 5 sites. The analysis includes participants in Sample B at the 11 completed sites.
Assessed by Healthy Eating Index-2015 scores (scale 0-100), with 100 representing the best possible score (i.e., nutritional quality best aligned with Dietary Guidelines for Americans)
Outcome measures
| Measure |
Intervention Food Pantries and Clients
n=85 Participants
Food pantries will transform to offer healthier and more appealing food; the effect on clients will be measured;
Intervention Food Pantries: Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors;
Intervention Clients: Clients who use and were recruited at intervention food pantries.
|
Control Food Pantries and Clients
n=102 Participants
Food pantries will make no changes during the evaluation period; the effect on clients will be measured;
Control Food Pantries: Normal food pantry operations during the evaluation period;
Control Clients: Clients who use and were recruited at control food pantries.
|
|---|---|---|
|
Nutritional Quality of Food Selected by Clients at the Food Pantry
|
60.6 Post-sample HEI score
Standard Deviation 11.8
|
64.0 Post-sample HEI score
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Baseline, 1 yearPopulation: COVID-19 disrupted intervention and post-evaluation activities in 5 sites. The analysis includes participants in Sample A at the 11 completed sites.
American Heart Association's Life's Simple 7 (LS7) scores (scale 0 -7), with 7 representing the best possible score for cardiovascular health
Outcome measures
| Measure |
Intervention Food Pantries and Clients
n=89 Participants
Food pantries will transform to offer healthier and more appealing food; the effect on clients will be measured;
Intervention Food Pantries: Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors;
Intervention Clients: Clients who use and were recruited at intervention food pantries.
|
Control Food Pantries and Clients
n=104 Participants
Food pantries will make no changes during the evaluation period; the effect on clients will be measured;
Control Food Pantries: Normal food pantry operations during the evaluation period;
Control Clients: Clients who use and were recruited at control food pantries.
|
|---|---|---|
|
Cardiovascular Health
|
-0.09 Pre-post change in LS7 score on a scale
Standard Error 0.15
|
0.41 Pre-post change in LS7 score on a scale
Standard Error 0.16
|
Adverse Events
Intervention Food Pantries and Clients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Control Food Pantries and Clients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
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