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Food InsecurityNCT03436589

The Indiana SNAP-Ed Long-term Study

A study testing Indiana SNAP-Ed in people with Food Insecurity and Food Security, run by Purdue University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of the study is to determine the immediate and long-term effects of SNAP-Ed on the food insecurity of the entire household, household adults, and household children. The study also aims to determine if there is a dose-response effect on food security after receiving 4 to 10 FNP lessons and if other… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Food Insecurity, Food Security, Education
What is being tested?
Indiana SNAP-Ed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
575 participants
Where
1 siteUnited States
Study dates
21 Sep 2013to 10 Mar 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • an interest in taking SNAP-Ed lessons
  • willingness to wait 1 year to start FNP lessons
  • eligibility for SNAP
  • age of at least 18 years
  • at least 1 child under 18 years old must live in the household
  • the household located in Indiana
Show all 10Show fewer
  • ability speak and read English
  • willingness to complete three 45 minute surveys at the designated time intervals
  • willingness to stay in touch with research staff through a study Facebook page
  • no previous participation in FNP lessons within the last year

Who cannot join

  • not meeting the inclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Purdue University

    West Lafayette, Indiana, 47907

Other trials in United States

About this study

Official title: Understanding the Immediate and Long-term Effects of Supplemental Nutrition Assistance Program-Education as an Intervention to Improve Food Security Among Households With Children in Indiana

The goal of the study is to determine the immediate and long-term effects of SNAP-Ed on the food insecurity of the entire household, household adults, and household children. The study also aims to determine if there is a dose-response effect on food security after receiving 4 to 10 FNP lessons and if other characteristics influence the change in food security status.

Read the detailed description

FNP educators, employees of Purdue University Extension, across Indiana will help facilitate the study. FNP educators have completed CITI training as a requirement for employment through Purdue University Extension. Before recruiting study participants, participating FNP educators will attend training sessions facilitated by the co-investigators of the study. The training sessions will include instructions on how to interact with participants, answer questions related to the study, and protocol for administering surveys, keeping participant information private, and the use of identification numbers. The study goals and hypothesis will not be shared with the FNP educators in order to keep their work with the participants as unbiased as possible.

After completion of the screening survey and consent process, FNP educators will randomize participants into one of two groups: control or experimental. The FNP educators will be assigned a random number using Excel and then listed in order from least to greatest according to their random number. The first half of the FNP educators will assign their first recruited participants to the experimental group. After the first assignment, they will alternate assigning participants to either study group every other appointment. The second half of the FNP educators will assign first recruited participants to the control group. After the first assignment, they will also alternate assigning participants to either study group every other appointment. The control group will wait 1 year before starting FNP lessons. The experimental group will start FNP lessons immediately. Participants in the experimental group must take at least the first 4 FNP lessons within a time period of 4 to 10 weeks. The FNP includes 12 lessons and participants may take the additional 6 lessons if desired.

All participants will complete three 45 minute surveys. The first survey will be administered upon enrollment in the study. Participants in the experimental group will take the second survey after they have completed the first 4 lessons between 4 and 10 weeks after enrollment in the study. Control participants will take the second survey after 4 to 10 weeks with no lessons. Since participants will be recruited on a rolling basis, they will take surveys at different times within a designated time period. The third survey will be administered to both groups after 1 year of participation in the study. The third survey will be offered online. Surveys are comprised of the US Household Food Security Survey Module from the United States Department of Agriculture Economic Research Service, questions querying household and individual level characteristics, and the Indiana Food and Nutrition Program Evaluation Tool.

Two study Facebook pages will be used to keep participants engaged in the study over the year. One page will be only for the control group and another page will be only for the experimental group. Both Facebook pages will be identical in content and will prevent the experimental groups from sharing any nutrition or resource management information with the control group. The Facebook pages will include a study logo, non-nutrition and non-resource management related educational material that will cover topics such as parenting, safety, child development, fun activities to do with children, and relationships The Facebook pages will serve to keep participants engaged and to help prevent attrition. The Facebook pages will be updated monthly with new material and postings.

Researchers plan to track which study participants participate in the study Facebook pages without matching their names to their participant identification numbers. In order to carry out this procedure, researchers will make a list of all of the names that appear on the study Facebook pages at the end of recruitment in January 2014. Then researchers will send the entire list of Facebook study participants to the FNP Educators who are the only study personnel with information linking participant names to their identification numbers. FNP Educators will look through the list to see which of their clients are participating in the study and on a study Facebook page. FNP Educators will then send the researchers only the participant identification numbers of those study participants using the study Facebook page. No names matched with identification numbers will be sent to the researchers in order to preserve the privacy of the study participants through confidentiality. The purpose of collecting information on which study participants participate on the study Facebook pages will be useful for controlling for the potential confounding that exposure to the Facebook page may introduce. The Facebook pages are useful to keep participants engaged, however, they also introduce a new exposure besides the exposure of interest, the SNAP-Ed lessons. There may be differential participation in the Facebook page among the intervention and control groups and adjusting for this exposure in the analysis will allow the researchers a clearer picture of the relationship between the intervention (SNAP-Ed lessons) and the outcome of interest (food insecurity).

FNP Educators will collect electronic mailing (e-mail) addresses from all study participants willing to provide this information. The purpose of collecting e-mail addresses is to provide researchers with the ability to administer the final survey online. There is the possibility that FNP Educators will not be able to administer Survey 3 one year from administering the first survey due to a lapse in appropriations to SNAP-Ed.

Being tested
Indiana SNAP-Ed
Keywords
Supplemental Nutrition Assistance Program-Education, nutrition education intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indiana SNAP-EdBehavioural

    Also called Small Steps to Health Curriculum

    First four Indiana SNAP-Ed nutrition education lessons served as the intervention

Study groups in NCT03436589
Study groupRoleWhat they receive
Control GroupNo interventionParticipants who met eligibility requirements and agreed to be randomly allocated to a treatment group. The control group participants received no lessons. Control group participants received the same study assessments at the same timepoints as the intervention group. The control group participants may have had limited contact with the nutrition educators only to update contact information, to set or remind of appointments to complete study assessments, or to receive non-nutrition or non-resource management resources.
Intervention GroupExperimentalParticipants who met eligibility requirements and agreed to be randomly allocated to a treatment group.The Intervention group participants received lessons from the nutrition educators, completed the same study assessments at the same timepoints as the control group, and may have had additional interaction with the nutrition educators in accordance with normal Indiana SNAP-Ed protocol.
Receives: Behavioral: Indiana SNAP-Ed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Household Food Security, Food Security Among Adults, Food Security Among Children from baseline to 1-year follow-up

    Score and Status as measured by 18-item US Household Food Security Survey Module at baseline and 1-year follow-up assessment time points

    Measured: Baseline assessments were completed upon recruitment and 1-year follow-up assessments were completed approximately 1 year after baseline assessments; 12-month reference period at baseline and 1-year follow-up assessments

Secondary outcomes (1)
  1. Change in Household Food Security, Food Security Among Adults, Food Security Among Children from baseline to Post-intervention

    Score and Status as measured by 18-item US Household Food Security Survey Module at baseline and post-intervention assessment time points

    Measured: Post-intervention food security score was assessed 4-10 weeks after baseline and included a 30-day reference period at post-intervention assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start21 Sep 2013
  3. Primary completion10 Mar 2015
  4. Study completion10 Mar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel-arm intervention with inactive control group and intervention group
Masking
Single blind
Who is masked
Participant
Enrolment
575 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03436589
Sponsor's protocol ID
1306013723
Status last verified
Feb 2018
First submitted
12 Feb 2018
Last updated
19 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rivera RL, Maulding MK, Abbott AR, Craig BA, Eicher-Miller HA. SNAP-Ed (Supplemental Nutrition Assistance Program-Education) Increases Long-Term Food Security among Indiana Households with Children in a Randomized Controlled Study. J Nutr. 2016 Nov;146(11):2375-2382. doi: 10.3945/jn.116.231373. Epub 2016 Sep 28.

    PubMed 27683869
  • Rivera RL, Dunne J, Maulding MK, Wang Q, Savaiano DA, Nickols-Richardson SM, Eicher-Miller HA. Exploring the association of urban or rural county status and environmental, nutrition- and lifestyle-related resources with the efficacy of SNAP-Ed (Supplemental Nutrition Assistance Program-Education) to improve food security. Public Health Nutr. 2018 Apr;21(5):957-966. doi: 10.1017/S1368980017003391. Epub 2017 Dec 4.

    PubMed 29199629

Questions about this trial

What is this clinical trial studying?

A study testing Indiana SNAP-Ed in people with Food Insecurity and Food Security, run by Purdue University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Household Food Security, Food Security Among Adults, Food Security Among Children from baseline to 1-year follow-up (time frame: Baseline assessments were completed upon recruitment and 1-year follow-up assessments were completed approximately 1 year after baseline assessments; 12-month reference period at baseline and 1-year follow-up assessments). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03436589, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.

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