Behavioral ChangesNCT05633251
Using Reinforcement Schedules to Increase Fruit&Vegetable Intake, Reduce Waste, and Increase School Lunch Participation
A study testing Variable (random) interval, Variable (non-random) interval and Variable (random) interval with table tents in people with Behavioral Changes and Psychology, Social, run by New Mexico State University at 1 site in United States.
Trial summary
Using small monetary rewards to reinforce healthy behaviors, such as the consumption of fruits and vegetables (F\&V), the investigators tested fixed and variable reinforcement schedules in three middle schools. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral Changes, Psychology, Social, Nutrition
- What is being tested?
- Variable (random) interval, Variable (non-random) interval and Variable (random) interval with table tents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,626 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2015to 6 May 2016
- 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 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- students attending three participating middle schools (Ysleta Independent School District)
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Ysleta Independent School District
El Paso, Texas, 79925
About this study
Official title: Using Reinforcement Schedules to Improve Carotenoid Levels, Reduce Fruit and Vegetable Waste, and Increase School Lunch Participation in El Paso
Using small monetary rewards to reinforce healthy behaviors, such as the consumption of fruits and vegetables (F\&V), the investigators tested fixed and variable reinforcement schedules in three middle schools.
The investigators measured carotenoid levels, as a biomarker of F\&V intake, and F\&V waste over the intervention time frame. The investigators also tracked the school lunch participation rates over time.
- Conditions
- Behavioral Changes, Psychology, Social, Nutrition
- Being tested
- Variable (random) interval, Variable (non-random) interval, Variable (random) interval with table tents, Control
- Keywords
- fruit, vegetable, food waste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variable (random) intervalBehavioural
Using Variable (Random) Interval Reinforcement Schedules to Increase Fruit and Vegetable Intake, Reduce Fruit and Vegetable Waste, and Increase School Lunch Participation
Variable (non-random) intervalBehavioural
Using Variable (Non-random) Interval Reinforcement Schedules to Increase Fruit and Vegetable Intake, Reduce Fruit and Vegetable Waste, and Increase School Lunch Participation
Variable (random) interval with table tentsBehavioural
Using Variable (Random) Interval Reinforcement Schedules and Table Tents with Health-related Messages to Increase Fruit and Vegetable Intake, Reduce Fruit and Vegetable Waste, and Increase School Lunch Participation
ControlBehavioural
No intervention
| Study group | Role | What they receive |
|---|---|---|
| School 1 | Experimental | Not described Receives: Behavioral: Variable (non-random) interval; Behavioral: Control |
| School 2 | Experimental | Not described Receives: Behavioral: Variable (random) interval; Behavioral: Control |
| School 3 | Experimental | Not described Receives: Behavioral: Variable (random) interval; Behavioral: Variable (random) interval with table tents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in food waste
Daily fruit, vegetable, and other food waste (in lbs)
Measured: 24 weeks
Change in fruit and vegetable intake
As measured by carotenoid level, a biomarker for total fruit and vegetable intake; measured before and after the intervention
Measured: 12 weeks
Secondary outcomes (1)
School lunch participation rates
Number of participants in the school lunch program
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start14 Sep 2015
- Primary completion6 May 2016
- Study completion6 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral ChangesStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Number of participants below is best estimate of students exposed to the intervention based on school lunch participation rates.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,626 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico State University
- Sponsor type
- University, hospital or other
- Collaborators
- Paso del Norte Health Foundation, University of Texas, Brigham Young University, Ysleta Independent School District, El Paso
- Responsible party
- Principal investigator, Mihai Niculescu, New Mexico State University
- Investigators
- Mihai Niculescu, PhD, Principal investigator, New Mexico State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633251
- Sponsor's protocol ID
- 12335 & 12324
- Status last verified
- Nov 2022
- First submitted
- 27 Dec 2020
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Reinforcement Schedules to Improve Carotenoid Levels, Reduce Fruit and Vegetable Waste, and Increase School Lunch Participation in El Paso
- ClinicalTrials.gov ID
- NCT05633251
- Acronym / sponsor ID
- 12335 & 12324
- Conditions
- Behavioral Changes, Psychology, Social, Nutrition
- Keywords
- fruit, vegetable, food waste
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,626 participants (actual)
- Lead sponsor
- New Mexico State UniversityUniversity, hospital or other
- Collaborators
- Paso del Norte Health Foundation, University of Texas, Brigham Young University, Ysleta Independent School District, El Paso
- Study start
- 14 Sep 2015 (actual)
- Primary completion
- 6 May 2016 (actual)
- Study completion
- 6 May 2016 (actual)
- First posted
- 1 Dec 2022 (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.
Using small monetary rewards to reinforce healthy behaviors, such as the consumption of fruits and vegetables (F\&V), the investigators tested fixed and variable reinforcement schedules in three middle schools.
The investigators measured carotenoid levels, as a biomarker of F\&V intake, and F\&V waste over the intervention time frame. The investigators also tracked the school lunch participation rates over time.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Number of participants below is best estimate of students exposed to the intervention based on school lunch participation rates.
| Arm | Type | Receives |
|---|---|---|
| School 1 | Experimental | Behavioral: Variable (non-random) interval, Behavioral: Control |
| School 2 | Experimental | Behavioral: Variable (random) interval, Behavioral: Control |
| School 3 | Experimental | Behavioral: Variable (random) interval, Behavioral: Variable (random) interval with table tents |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- students attending three participating middle schools (Ysleta Independent School District)
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Variable (random) intervalUsing Variable (Random) Interval Reinforcement Schedules to Increase Fruit and Vegetable Intake, Reduce Fruit and Vegetable Waste, and Increase School Lunch Participation | Behavioural | School 2, School 3 |
| Variable (non-random) intervalUsing Variable (Non-random) Interval Reinforcement Schedules to Increase Fruit and Vegetable Intake, Reduce Fruit and Vegetable Waste, and Increase School Lunch Participation | Behavioural | School 1 |
| Variable (random) interval with table tentsUsing Variable (Random) Interval Reinforcement Schedules and Table Tents with Health-related Messages to Increase Fruit and Vegetable Intake, Reduce Fruit and Vegetable Waste, and Increase School Lunch Participation | Behavioural | School 3 |
| ControlNo intervention | Behavioural | School 1, School 2 |
Primary outcome
Change in food waste
Time frame: 24 weeks
Daily fruit, vegetable, and other food waste (in lbs)
Change in fruit and vegetable intake
Time frame: 12 weeks
As measured by carotenoid level, a biomarker for total fruit and vegetable intake; measured before and after the intervention
1 secondary outcome
School lunch participation rates
Time frame: 32 weeks
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 Dec 2022.
- 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.
Mihai Niculescu, PhD principal investigator
New Mexico State 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 Variable (random) interval, Variable (non-random) interval and Variable (random) interval with table tents in people with Behavioral Changes and Psychology, Social, run by New Mexico State 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 1 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 1 Dec 2022. 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 food waste (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 Dec 2022.