Can a Meal Replacement Help Solve Hunger in America?

Methods

Summary

Enrollment

Participants will be recruited over two weeks from a local Dallas food pantry. The study objectives will be explained and any prospective participants will be asked to provide informed consent in order to join the study. As part of the enrollment process, consenting participants will also be asked to complete an initial survey. This survey will collect demographic information, and also measure food security, dietary habits and general health through the use of validated questionnaires. The survey takes approximately 10 minutes to complete and will be available in English and Spanish. 

Follow-up

Once enrolled, we will establish early contact with participants through phone call or text message to offer any necessary support on Nosha use.

Participants will be asked to collect their Nosha meals from the food pantry whenever they do their shopping at the pantry, typically on a biweekly basis. The Nosha meals will be distributed to participants by the intake coordinators as part of their visit registration. Participant name and date of Nosha meal pickups will be recorded. 

Participants will be asked to repeat the survey and answer additional questions at the 12-week endpoint of the study. The survey will be administered by the food pantry personnel and will reassess measures of food security, along with Nosha use, other dietary habits and general health. 

Conclusion

At the conclusion of the study, brief in-person interviews will be conducted with participants to corroborate our survey data. We will speak with individuals who discontinued drinking Nosha at some point during the study will be selected, as well as those who used Nosha regularly throughout the entire study. These discussions will be opportunities to collect more detailed information on Nosha's benefits and shortcomings for food pantry shoppers.

Challenges

High attrition rates could significantly undermine our study. It will be important for us to distinguish between attrition that occurs is simply due to irregular food pantry shopping, and attrition that results from disinterest in Nosha, through survey questions and in-person interviews. 

We are also unsure whether the validated survey questions posed to participants are ideal for identifying the effects produced by our intervention. To address this possibility, we will incorporate open-ended questions as part of our survey. We also expect our in-person interviews to help us capture unquantified benefits or shortcomings of Nosha use.

Pre Analysis Plan

A power calculation was made to determine the ideal sample size for this study. To have an 80% chance of picking up an effect size of .3, we determined we would need 45 individuals to join the program. We chose to enroll 75 individuals in order to be able to absorb a 40% attrition rate, which was a conservative estimate based on our smaller pilot study where we saw an attrition rate of 30%.

A linear mixed-effects regression was conducted to test the difference between the scores of individuals prior to starting the Nosha program and after completing it. These linear mixed-effects models all take the form: