Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03436589
Other study ID # 1306013723
Secondary ID
Status Completed
Phase N/A
First received February 12, 2018
Last updated February 12, 2018
Start date September 21, 2013
Est. completion date March 10, 2015

Study information

Verified date February 2018
Source Purdue University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 characteristics influence the change in food security status.


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.


Recruitment information / eligibility

Status Completed
Enrollment 575
Est. completion date March 10, 2015
Est. primary completion date March 10, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- not meeting the inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Purdue University West Lafayette Indiana

Sponsors (4)

Lead Sponsor Collaborator
Purdue University North Central Nutrition Education Center of Excellence, Purdue University Cooperative Extension Family Nutrition Program, University of Kentucky Center for Poverty Research

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. 2017 Dec 4:1-10. doi: 10.1017/S1368980017003391. [Epub ahead of print] — View Citation

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. Epub 2016 Sep 28. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 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 Post-intervention food security score was assessed 4-10 weeks after baseline and included a 30-day reference period at post-intervention assessment
See also
  Status Clinical Trial Phase
Completed NCT04083924 - Preclinical Medical Student Echocardiography Training American Society of Echocardiography Curriculum N/A
Completed NCT05013476 - Tele-Ultrasound: VIrtual Hands-on Education for Novice Users N/A
Completed NCT03678077 - Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury
Completed NCT05007704 - Competencies Required by Anesthesiologists Managing Critically Ill Patients
Completed NCT04082845 - Effect of Web-Based Training With Thyroidectomy Patients N/A
Completed NCT05335759 - Coaching Programme for Preceptorship of Undergraduate Nurses' Students
Not yet recruiting NCT04959045 - The Effect of Flipped Classroom Teaching Method on Academic Achievement and Skill Learning Level in Skills Education N/A
Enrolling by invitation NCT03587233 - Are Women With Higher Professional Status More Sedentary Compared to Men? N/A
Recruiting NCT05086783 - Video-based Coaching (VBC) in Gynecologic Surgery N/A
Completed NCT06046378 - The Effect of Digital Stories Prepared With Digital Audio File (Podcast) on Midwifery Learning N/A
Completed NCT04186390 - Learning Small Bowel Capsule Endoscopy
Recruiting NCT02377908 - European Postgraduate Training in Geriatric Medicine N/A
Terminated NCT01720017 - Impact of Manikin Training on Airtraq Avant Learning Curve in Predicted Difficult Airways N/A
Completed NCT01001286 - Questscope Non-Formal Education Impact Study Phase 2
Completed NCT00887185 - Validation/Dissemination Of A Temporal Bone Dissection Simulator Phase 2
Withdrawn NCT00425295 - Effectiveness of Human Simulation Training for Medical Crisis Management Skills Phase 1
Completed NCT04343352 - Evaluation of the Efficiency of Mobile Application for Parents of Children With Epilepsy N/A
Not yet recruiting NCT06091462 - Virtual Reality and Nursing Students and Dementia N/A
Completed NCT05974943 - The Effect of Problem Solving and Decision Making Training Given to Nurses Managers N/A
Recruiting NCT06221410 - Motivation in Learning Medical Terminology N/A