The Indiana SNAP-Ed Long-term Study Sequel

March 27, 2023 updated by: Heather Eicher-Miller, Purdue University

The Effect of Supplemental Nutrition Assistance Program-Education on the Dietary Intake of Low-income Indiana Participants

The goal of the study is to determine the immediate and long-term effects of SNAP-Ed on the dietary intake of participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this study is to determine the efficacy of SNAP-Ed to improve the immediate and long-term dietary quality (using the Healthy Eating Index (HEI)), BMI (measured height and weight), and food security (using the 18-item US HFSSM) and how the provision of SNAP-Ed with the presence of other characteristics can mediate improvement in these outcomes. The hypothesis of this study is that dietary quality and food security will improve and BMI will remain steady over the short-term, and these improvements will be maintained over a 1-year, or "long-term", time frame in participants receiving SNAP-Ed compared to those not receiving SNAP-Ed. Results may be used as a basis for changes to the program or policies relevant to SNAP-Ed and other nutrition education programs throughout the US.

NEP educators are considered key personnel because they will have direct contact with study participants; however, they will not have any part in data entry, analysis, or dissemination of study results. NEP educators, employees of Purdue University Extension, across Indiana will help facilitate the study. NEP educators have completed CITI training as a requirement for employment through Purdue University Extension. Before recruiting study participants, participating NEP 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, measuring height and weight, keeping participant information private, and the use of identification numbers. The study goals and hypothesis will not be shared with the NEP educators in order to keep their work with the participants as unbiased as possible.

NEP educators will recruit study participants who are interested in participating in NEP. The details of recruitment are described in Section D. A screening survey determining eligibility will be administered in addition to an explanation of consent. After completion of the screening survey and consent process, NEP educators will randomize participants into one of two groups: control or experimental. The NEP 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 NEP educators will assign their first recruited participants to the experimental group. After the first assignment, they will alternate assigning participants to either study group in an "every other" participant fashion. The second half of the NEP educators will assign their first recruited participants to the control group. After the first assignment, they will also alternate assigning participants to either study group in an "every other" participant fashion. The control group will wait 1 year from taking the second survey before starting NEP lessons. The experimental group will start NEP lessons immediately. Participants in the experimental group must take at least the first 4 NEP lessons within a time period of 4 to 10 weeks. The NEP SNAP-Ed curriculum includes 10 lessons, and participants may take the additional 6 lessons if desired.

All participants will complete three 30 minute surveys throughout the study. Surveys will be administered by NEP educators using the Qualtrics Offline Application on their program-provided iPads or paper 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 1 year after the second survey. 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.

Participants will also complete two 24-hour dietary recalls using the Automated Self-Assisted 24-hour recall (ASA-24) and one food frequency questionnaire (FFQ) using the Diet History Questionnaire II (DHQ II) at each data collection time point. Both instruments are online and complementary dietary assessment tools created by the National Cancer Institute and have a respondent and researcher website. Results will be analyzed by the researchers using the researcher website. One dietary recall and the FFQ may be administered by the NEP Educators immediately following the in person survey, or a link to complete the dietary recall and FFQ online will be emailed to the participant within 2 days, or the participant can request to complete the dietary recalls and FFQ over the phone with the co-investigators at Purdue within 7 days after completing the survey. A script will be provided for the Purdue researchers to administer the dietary recalls and FFQ. The completion of the dietary recalls and the FFQ is necessary to perform complex modeling techniques for estimating usual dietary intake. The program that administers the dietary recalls assists participants through the recall process using an animated guide with audio and visual cues. Previous research has shown that the majority of Indiana SNAP-Ed participants have a computer with high-speed Internet connection in their home or residence. Participants without email, without access to a computer with internet, or with limited computer skills will be instructed to complete the assessments via telephone with assistance from researchers. If assistance from researchers is needed via telephone, participant identifying information will not be collected at that time. Participants will be identified only by their participant identification number, which they will receive upon enrollment in the study. Participants will provide days and time frames over the following week when they will be available to complete the dietary assessments over the phone with Purdue researchers. In addition, participants may call the co-investigator's Purdue office phone number any time after the survey for assistance with completing the dietary assessments. If the first dietary recall and FFQ have not been completed within 4 days after the survey, researchers will call the participant no more than once per day to complete the first dietary recall and FFQ over the phone at that time or to set up appointments to complete the dietary recalls and FFQ over the phone with researchers within the 7 days after completing the in person survey. The second dietary recall should be completed 24 hours after the first dietary recall at the earliest but before 9 days after completing the in person survey. Participants will have the same options as described above to complete the second dietary recall.

In addition to the survey, dietary recalls, and FFQ, NEP educators will take height and weight measurements on each participant at each assessment time point. Weights will be measured using the SECA 869 mobile medical flat scale with remote display. Heights will be measured using the SECA 213 mobile stadiometer. This weight scale and stadiometer are research grade measurement tools. Height and weight measurements will be taken following the Centers for Disease Control and Prevention (CDC) National Health and Nutrition Examination Survey (NHANES) anthropometry manual guidelines. Height and weight measurements will be completed in a private setting or privacy screens will be used. Only the NEP educators will be able to see the measurements. Three measurements will be taken at each assessment time point in order to calculate an average. Participants will be allowed to know their measurements upon request at the time of measurement. Researchers will use these measurements to calculate BMI.

An in person survey, two dietary recalls, one FFQ, and height and weight measurements will be completed for each participant at each of the three assessment time points. The first and third assessments will cover a reference period the past 12 months, while the second assessment will cover the past 30 days. Participants randomized to the control group will be provided the opportunity to complete the SNAP-Ed program at the completion of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
261

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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
  • the household located in Indiana
  • ability speak and read English
  • willingness to complete three 45 minute surveys and up to 2 dietary recalls and a food frequency questionnaire at the designated time intervals
  • willingness to stay in touch with research staff during the study period
  • no previous participation in NEP lessons within the last year

Exclusion Criteria:

- pregnant women were excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
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.
Experimental: Intervention Group
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.
Behavioral: Indiana SNAP-Ed
First four Indiana SNAP-Ed nutrition education lessons served as the intervention
Other Names:
  • Small Steps to Health Curriculum

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Long-term Change in Dietary Intake
Time Frame: Baseline assessments were completed upon recruitment and 1-year follow-up assessments were completed approximately 1 year after baseline assessments
The Healthy Eating Index-2010 was used to characterize diet quality from National Cancer Institute Automated Self-Administered 24-hour Dietary Recall Tool
Baseline assessments were completed upon recruitment and 1-year follow-up assessments were completed approximately 1 year after baseline assessments

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Long-term Change in Nutrient Intake
Time Frame: Baseline assessments were completed upon recruitment and 1-year follow-up assessments were completed approximately 1 year after baseline assessments
Mean Usual Intake was determined from National Cancer Institute Automated Self-Administered 24-hour Dietary Recall Tool
Baseline assessments were completed upon recruitment and 1-year follow-up assessments were completed approximately 1 year after baseline assessments
Long-term Change in Household Food Security
Time Frame: Baseline assessments were completed upon recruitment and 1-year follow-up assessments were completed approximately 1 year after baseline assessments
Food security was 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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI)
Time Frame: Baseline assessments were completed upon recruitment and 1-year follow-up assessments were completed approximately 1 year after baseline assessments
SNAP-Ed paraprofessionals measured height and weight to calculate BMI
Baseline assessments were completed upon recruitment and 1-year follow-up assessments were completed approximately 1 year after baseline assessments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Purdue University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heather A Eicher-Miller, PhD, Purdue University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1507016295

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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