ObesitySNAP-EdNCT01918020
Impact Study of Minnesota SNAP-Ed Health and Nutrition Education Programs
A study testing Go Wild with Fruits and Veggies! and Go Wild with Fruits and Veggies! delayed in people with Obesity and Child, run by University of Minnesota at 1 site in United States.
Trial summary
Supplemental Nutrition Assistance Program - Education (SNAP-Ed) is a national initiative with the goal of improving the health and wellbeing of low income families. University of Minnesota Extension every year offers nearly 4000 educational events, serving approximately 70,000 Minnesotans through the program. Read more about this study
- Who is it for?
- Ages 8 to 9 years
- What is being tested?
- Go Wild with Fruits and Veggies! and Go Wild with Fruits and Veggies! delayed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 796 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2013
- 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 8 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Third grade elementary students
- Schools that are eligible for SNAP ED funding (have more than 50% students received free/reduced lunch)
Who cannot join
- Other grade elementary students
- Schools that are not eligible for SNAP ED funding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Extension Center for Family Development
Saint Paul, Minnesota, 55108
About this study
Supplemental Nutrition Assistance Program - Education (SNAP-Ed) is a national initiative with the goal of improving the health and wellbeing of low income families. University of Minnesota Extension every year offers nearly 4000 educational events, serving approximately 70,000 Minnesotans through the program. Extension is conducting an impact study to determine program effectiveness and assess sustained changes of participants and their families that can be directly attributed to programming on a larger and methodically sound scale.
- Being tested
- Go Wild with Fruits and Veggies!, Go Wild with Fruits and Veggies! delayed
- Keywords
- Fruit, Vegetables, Motor Activity
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go Wild with Fruits and Veggies!Behavioural
Fruits and Vegetables
Go Wild with Fruits and Veggies! delayedBehavioural
Go Wild with Fruits and Veggies! delayed
| Study group | Role | What they receive |
|---|---|---|
| Go Wild with Fruits and Veggies! | Experimental | This group will receive nutrition education to learn about fruits and vegetables and physical activities right from the start of the experiment. Receives: Behavioral: Go Wild with Fruits and Veggies! |
| Go Wild with Fruits and Veggies! delayed | Other | This group will only receive nutrition education about 4 months after the experiment starts. Receives: Behavioral: Go Wild with Fruits and Veggies! delayed |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess changes in adiposity level among the program participants indicated by BMI measurements.
We assess BMI of participants by using standardized stadiometers and weighing scales to attain weights and heights. Birthdates and sex of program participants were also acquired. Then, using the information of their birthdates, weight and heights, BMI percentile and BMI will be computed and analyzed.
Measured: We will assess BMI in the 1st, 3rd, 5th and 12th month
Secondary outcomes (2)
To assess changes of fruit and vegetable intake and among program participants.
We use fruits and vegetables frequency retrospective questions and "A day in the life" survey to assess the fruits and vegetable intake. Composite values of these two measures will decide the levels of changes in intakes.
Measured: We will measure the changes of fruits and vegetable intakes in the 1st month (baseline), 3rd month, 7th month, and 12th month
To assess changes of physical activity levels among program participants.
We use Yamax Digiwalker (SW700) pedometer, physical activity questions, and parent proxy surveys to assess the physical activity levels. Composite values of all measures will be computed to determine the levels of change.
Measured: We will measure the changes of physical activity level in the 1st month (baseline), 3rd month, 7th month, and 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startSep 2012
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 796 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- G. Ali Hurtado, Doctorate, Principal investigator, University of Minnesota Extension Center for Family Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918020
- Sponsor's protocol ID
- 1206S15445
- Acronym
- SNAP-Ed
- Status last verified
- Oct 2019
- First submitted
- 26 Jul 2013
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Study of Minnesota SNAP-Ed Health and Nutrition Education Programs
- ClinicalTrials.gov ID
- NCT01918020
- Acronym / sponsor ID
- SNAP-Ed / 1206S15445
- Keywords
- Fruit, Vegetables, Motor Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 796 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Aug 2013 (estimated)
- 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.
Supplemental Nutrition Assistance Program - Education (SNAP-Ed) is a national initiative with the goal of improving the health and wellbeing of low income families. University of Minnesota Extension every year offers nearly 4000 educational events, serving approximately 70,000 Minnesotans through the program. Extension is conducting an impact study to determine program effectiveness and assess sustained changes of participants and their families that can be directly attributed to programming on a larger and methodically sound scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Go Wild with Fruits and Veggies! | Experimental | Behavioral: Go Wild with Fruits and Veggies!This group will receive nutrition education to learn about fruits and vegetables and physical activities right from the start of the experiment. |
| Go Wild with Fruits and Veggies! delayed | Other | Behavioral: Go Wild with Fruits and Veggies! delayedThis group will only receive nutrition education about 4 months after the experiment starts. |
Who may qualify
- Ages
- 8 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Third grade elementary students
- Schools that are eligible for SNAP ED funding (have more than 50% students received free/reduced lunch)
Key exclusion criteria (2 listed)
- Other grade elementary students
- Schools that are not eligible for SNAP ED funding
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 |
|---|---|---|
| Go Wild with Fruits and Veggies!Fruits and Vegetables | Behavioural | Go Wild with Fruits and Veggies! |
| Go Wild with Fruits and Veggies! delayedGo Wild with Fruits and Veggies! delayed | Behavioural | Go Wild with Fruits and Veggies! delayed |
Primary outcome
To assess changes in adiposity level among the program participants indicated by BMI measurements.
Time frame: We will assess BMI in the 1st, 3rd, 5th and 12th month
We assess BMI of participants by using standardized stadiometers and weighing scales to attain weights and heights. Birthdates and sex of program participants were also acquired. Then, using the information of their birthdates, weight and heights, BMI percentile and BMI will be computed and analyzed.
2 secondary outcomes
To assess changes of fruit and vegetable intake and among program participants.
Time frame: We will measure the changes of fruits and vegetable intakes in the 1st month (baseline), 3rd month, 7th month, and 12th month
To assess changes of physical activity levels among program participants.
Time frame: We will measure the changes of physical activity level in the 1st month (baseline), 3rd month, 7th month, and 12th month
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 1 Nov 2019.
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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.
G. Ali Hurtado, Doctorate principal investigator
University of Minnesota Extension Center for Family Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Go Wild with Fruits and Veggies! and Go Wild with Fruits and Veggies! delayed in people with Obesity and Child, run by University of Minnesota 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 2 inclusion and 2 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 1 Nov 2019. 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?
To assess changes in adiposity level among the program participants indicated by BMI measurements. (time frame: We will assess BMI in the 1st, 3rd, 5th and 12th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2019.