ObesityNCT01557218
Increasing the Variety of Vegetables and Fruits Served to Preschool Children at a Snack
A study testing Cucumber snack, Pepper snack and Tomato snack in people with Obesity and Feeding Behaviors, run by Penn State University at 1 site in United States.
Trial summary
Intake of vegetables and fruits in preschool children is less than recommended amounts. Although offering a variety of foods has been shown to increase intake, this effect has not been well studied for low-energy-dense foods. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Feeding Behaviors
- What is being tested?
- Cucumber snack, Pepper snack and Tomato snack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2011
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- attenders at the relevant child care center
Who cannot join
- allergy or sensitivity to any test food
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University Laboratory for the Study of Human Ingestive Behavior
University Park, Pennsylvania, 16802
About this study
Intake of vegetables and fruits in preschool children is less than recommended amounts. Although offering a variety of foods has been shown to increase intake, this effect has not been well studied for low-energy-dense foods. The purpose of this study was to test whether increasing the variety of vegetables and fruits served to preschool children affected the amount eaten. The hypotheses were that increasing the variety of vegetables and fruits would increase both the amount selected and the amount eaten.
- Conditions
- Obesity, Feeding Behaviors
- Being tested
- Cucumber snack, Pepper snack, Tomato snack, Vegetable variety snack, Apple snack
- Keywords
- Dietary variety, Vegetable intake, Fruit intake
- Medical subject headings
- Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cucumber snackOther
Three 300-g bowls of vegetables per table: three of cucumber slices
Pepper snackOther
Three 300-g bowls of vegetables per table: three of yellow pepper strips
Tomato snackOther
Three 300-g bowls of vegetables per table: three of grape tomatoes
Vegetable variety snackOther
Three 300-g bowls of vegetables per table: one each of cucumber slices, pepper strips, and grape tomatoes
Apple snackOther
Three 300-g bowls of fruits per table: three of apple wedges
Peach snackOther
Three 300-g bowls of fruits per table: three of peach slices
Pineapple snackOther
Three 300-g bowls of fruits per table: three of pineapple half-rings
Fruit variety snackOther
Three 300-g bowls of fruits per table: of each of apple wedges, peach slices, and pineapple half-rings
| Study group | Role | What they receive |
|---|---|---|
| Cucumber | Experimental | Not described Receives: Other: Cucumber snack |
| Pepper | Experimental | Not described Receives: Other: Pepper snack |
| Tomato | Experimental | Not described Receives: Other: Tomato snack |
| Vegetable variety | Experimental | Not described Receives: Other: Vegetable variety snack |
| Apple | Experimental | Not described Receives: Other: Apple snack |
| Peach | Experimental | Not described Receives: Other: Peach snack |
| Pineapple | Experimental | Not described Receives: Other: Pineapple snack |
| Fruit variety | Experimental | Not described Receives: Other: Fruit variety snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intake of vegetables and fruit
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionMay 2011
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 ObesityStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara J. Rolls, Penn State University
- Investigators
- Barbara J. Rolls, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557218
- Sponsor's protocol ID
- ChildFood101
- Other IDs
- R01DK082580
- Status last verified
- Feb 2013
- First submitted
- 15 Mar 2012
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Roe LS, Meengs JS, Birch LL, Rolls BJ. Serving a variety of vegetables and fruit as a snack increased intake in preschool children. Am J Clin Nutr. 2013 Sep;98(3):693-9. doi: 10.3945/ajcn.113.062901. Epub 2013 Jul 31.
PubMed 23902783
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing the Variety of Vegetables and Fruits Served to Preschool Children at a Snack
- ClinicalTrials.gov ID
- NCT01557218
- Acronym / sponsor ID
- ChildFood101
- Conditions
- Obesity, Feeding Behaviors
- Keywords
- Dietary variety, Vegetable intake, Fruit intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 19 Mar 2012 (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.
Intake of vegetables and fruits in preschool children is less than recommended amounts. Although offering a variety of foods has been shown to increase intake, this effect has not been well studied for low-energy-dense foods. The purpose of this study was to test whether increasing the variety of vegetables and fruits served to preschool children affected the amount eaten. The hypotheses were that increasing the variety of vegetables and fruits would increase both the amount selected and the amount eaten.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cucumber | Experimental | Other: Cucumber snack |
| Pepper | Experimental | Other: Pepper snack |
| Tomato | Experimental | Other: Tomato snack |
| Vegetable variety | Experimental | Other: Vegetable variety snack |
| Apple | Experimental | Other: Apple snack |
| Peach | Experimental | Other: Peach snack |
| Pineapple | Experimental | Other: Pineapple snack |
| Fruit variety | Experimental | Other: Fruit variety snack |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- attenders at the relevant child care center
Key exclusion criteria (1 listed)
- allergy or sensitivity to any test food
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 |
|---|---|---|
| Cucumber snackThree 300-g bowls of vegetables per table: three of cucumber slices | Other | Cucumber |
| Pepper snackThree 300-g bowls of vegetables per table: three of yellow pepper strips | Other | Pepper |
| Tomato snackThree 300-g bowls of vegetables per table: three of grape tomatoes | Other | Tomato |
| Vegetable variety snackThree 300-g bowls of vegetables per table: one each of cucumber slices, pepper strips, and grape tomatoes | Other | Vegetable variety |
| Apple snackThree 300-g bowls of fruits per table: three of apple wedges | Other | Apple |
| Peach snackThree 300-g bowls of fruits per table: three of peach slices | Other | Peach |
| Pineapple snackThree 300-g bowls of fruits per table: three of pineapple half-rings | Other | Pineapple |
| Fruit variety snackThree 300-g bowls of fruits per table: of each of apple wedges, peach slices, and pineapple half-rings | Other | Fruit variety |
Primary outcome
Intake of vegetables and fruit
Time frame: One 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 15 Feb 2013.
- Derived from this study: PubMed 23902783Roe LS, Meengs JS, Birch LL, Rolls BJ. Serving a variety of vegetables and fruit as a snack increased intake in preschool children. Am J Clin Nutr. 2013 Sep;98(3):693-9. doi: 10.3945/ajcn.113.062901. Epub 2013 Jul 31.
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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.
Barbara J. Rolls, PhD principal investigator
Penn 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 Cucumber snack, Pepper snack and Tomato snack in people with Obesity and Feeding Behaviors, run by Penn 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 15 Feb 2013. 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?
Intake of vegetables and fruit (time frame: One month). 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 NCT01557218, 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 15 Feb 2013.