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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Food Insecurity, Food Security, Education
- 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 group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants 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 Group | Experimental | Participants 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.
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)
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.
- First posted19 Feb 2018
- Study start21 Sep 2013
- Primary completion10 Mar 2015
- Study completion10 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky Center for Poverty Research, North Central Nutrition Education Center of Excellence
- Responsible party
- Principal investigator, Heather Eicher-Miller, Purdue University
- Investigators
- Heather A Eicher-Miller, PhD, Principal investigator, Purdue University
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 27683869Rivera 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03436589
- Acronym / sponsor ID
- 1306013723
- Conditions
- Food Insecurity, Food Security, Education
- Keywords
- Supplemental Nutrition Assistance Program-Education, nutrition education intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- University of Kentucky Center for Poverty Research, North Central Nutrition Education Center of Excellence
- Study start
- 21 Sep 2013 (actual)
- Primary completion
- 10 Mar 2015 (actual)
- Study completion
- 10 Mar 2015 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel-arm intervention with inactive control group and intervention group
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants 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 Group | Experimental | Behavioral: Indiana SNAP-EdParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indiana SNAP-EdAlso: Small Steps to Health CurriculumFirst four Indiana SNAP-Ed nutrition education lessons served as the intervention | Behavioural | Intervention Group |
Primary outcome
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
Score and Status as measured by 18-item US Household Food Security Survey Module at baseline and 1-year follow-up assessment time points
1 secondary outcome
Change in Household Food Security, Food Security Among Adults, Food Security Among Children from baseline to Post-intervention
Time frame: Post-intervention food security score was assessed 4-10 weeks after baseline and included a 30-day reference period at post-intervention assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Background: PubMed 27683869Rivera 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.
- Background: PubMed 29199629Rivera 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather A Eicher-Miller, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
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.