Nutrient Intake InadequacyNCT03436784
The Indiana SNAP-Ed Long-term Study Sequel
A study testing Indiana SNAP-Ed in people with Nutrient Intake Inadequacy, 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 dietary intake of participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrient Intake Inadequacy
- 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
- 261 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2015to 1 May 2017
- 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
- the household located in Indiana
- ability speak and read English
Show all 9Show fewer
- 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
Who cannot join
- pregnant women were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nutrient Intake Inadequacy
- Being tested
- Indiana SNAP-Ed
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.
Long-term Change in Dietary Intake
The Healthy Eating Index-2010 was used to characterize diet quality from National Cancer Institute Automated Self-Administered 24-hour Dietary Recall Tool
Measured: Baseline assessments were completed upon recruitment and 1-year follow-up assessments were completed approximately 1 year after baseline assessments
Secondary outcomes (2)
Long-term Change in Nutrient Intake
Mean Usual Intake was determined from National Cancer Institute Automated Self-Administered 24-hour Dietary Recall Tool
Measured: 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
Food security was 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
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 start8 Sep 2015
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrient Intake InadequacyStudies 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
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- 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
- NCT03436784
- Sponsor's protocol ID
- 1507016295
- Status last verified
- Mar 2023
- First submitted
- 12 Feb 2018
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qin Y, Craig BA, Bailey RL, Abbott AR, Connolly BA, Eicher-Miller HA. BMI Was Maintained Among Women with Low Incomes in Indiana Who Participated in Food Assistance and/or Federal Nutrition Education Over 1 Year. Curr Dev Nutr. 2026 Jan 30;10(3):107651. doi: 10.1016/j.cdnut.2026.107651. eCollection 2026 Mar.
PubMed 41783029
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Supplemental Nutrition Assistance Program-Education on the Dietary Intake of Low-income Indiana Participants
- ClinicalTrials.gov ID
- NCT03436784
- Acronym / sponsor ID
- 1507016295
- Conditions
- Nutrient Intake Inadequacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 8 Sep 2015 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (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 dietary intake of participants.
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 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 (9 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
- the household located in Indiana
Key exclusion criteria (1 listed)
- pregnant women were excluded
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
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
2 secondary outcomes
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
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
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 29 Mar 2023.
- Derived from this study: PubMed 41783029Qin Y, Craig BA, Bailey RL, Abbott AR, Connolly BA, Eicher-Miller HA. BMI Was Maintained Among Women with Low Incomes in Indiana Who Participated in Food Assistance and/or Federal Nutrition Education Over 1 Year. Curr Dev Nutr. 2026 Jan 30;10(3):107651. doi: 10.1016/j.cdnut.2026.107651. eCollection 2026 Mar.
- Individual participant dataSharing planned: No
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 Nutrient Intake Inadequacy, 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 9 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 29 Mar 2023. 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?
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). 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 NCT03436784, which also lists 1 linked publication.
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 29 Mar 2023.