- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07358390
Potatoes as a Strategy to Improve Diet Quality in Young Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The overall object of this study is to test potato-based strategies to improve diet quality in preschool age children. The specific aims are:
Aim 1: Determine if pairing potatoes with other less-preferred vegetables increases liking and intake of the non-potato vegetables.
Aim 2: Determine if potato-based dishes can be used strategically to reduce intake of more energy-dense entrees.
The effect of potato-based dishes on vegetable intake and total energy intake will be tested across four lunch-time sessions in preschool classrooms. Each lunch session will be randomly assigned to one of the potato dish conditions.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
University Park, Pennsylvania, United States, 16802
- Pennsylvania State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Child:
- Enrolled in participating Head Start classroom
- Age 2-6 years old
Parent:
- Parent/guardian of a participating child
- Age 18 years or older
- Able to read and answer questions in English
Teacher:
- Teacher/teaching staff member of a participating Head State classroom
- Age 18 years or older
- Able to read and answer questions in English
Exclusion Criteria:
Child:
- Allergy to potatoes
- Children who are not able to understand and answer questions in English may participate in all parts of the study except for the taste test ratings, which require the child to communicate with the research assistant
Parent:
- Child not enrolled in the study
Teacher exclusion criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Randomization order 1
Participants will complete the four conditions in the following order: 1) potato + vegetable, 2) potato appetizer, 3) no potato, and 4) potato and vegetable separate
|
A mixed dish of potatoes and other vegetables will be served at lunch
A potato dish will be served as an appetizer at lunch prior to the main course
A potato dish and a vegetable dish will be served separately at lunch
No potato dish will be served at lunch
|
|
Experimental: Randomization order 2
Participants will complete the four conditions in the following order: 1) no potato, 2) potato + vegetable, 3) potato and vegetable separate, and 4) potato appetizer
|
A mixed dish of potatoes and other vegetables will be served at lunch
A potato dish will be served as an appetizer at lunch prior to the main course
A potato dish and a vegetable dish will be served separately at lunch
No potato dish will be served at lunch
|
|
Experimental: Randomization order 3
Participants will complete the four conditions in the following order: 1) potato and vegetable separate, 2) potato appetizer, 3) no potato, and 4) potato + vegetable
|
A mixed dish of potatoes and other vegetables will be served at lunch
A potato dish will be served as an appetizer at lunch prior to the main course
A potato dish and a vegetable dish will be served separately at lunch
No potato dish will be served at lunch
|
|
Experimental: Randomization order 4
Participants will complete the four conditions in the following order: 1) potato appetizer, 2) no potato, 3) potato and vegetable separate, and 4) potato + vegetable
|
A mixed dish of potatoes and other vegetables will be served at lunch
A potato dish will be served as an appetizer at lunch prior to the main course
A potato dish and a vegetable dish will be served separately at lunch
No potato dish will be served at lunch
|
|
Experimental: Randomization order 5
Participants will complete the four conditions in the following order: 1) no potato, 2) potato and vegetable separate, 3) potato + vegetable, and 4) potato appetizer
|
A mixed dish of potatoes and other vegetables will be served at lunch
A potato dish will be served as an appetizer at lunch prior to the main course
A potato dish and a vegetable dish will be served separately at lunch
No potato dish will be served at lunch
|
|
Experimental: Randomization order 6
Participants will complete the four conditions in the following order: 1) potato + vegetable, 2) potato and vegetable separate, 3) potato appetizer, and 4) no potato
|
A mixed dish of potatoes and other vegetables will be served at lunch
A potato dish will be served as an appetizer at lunch prior to the main course
A potato dish and a vegetable dish will be served separately at lunch
No potato dish will be served at lunch
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intake of target vegetable at lunch
Time Frame: At each of four lunch sessions conducted once per week over four weeks
|
Intake of the non-potato target vegetable will be measured at each lunch session by weighing the food dish prior to serving and after the participant has finished eating
|
At each of four lunch sessions conducted once per week over four weeks
|
|
Entree intake at lunch
Time Frame: At each of four lunch sessions conducted once per week over four weeks
|
Intake of an energy-dense entree (macaroni and cheese) will be measured at each lunch session by weighing the food dish prior to serving and after the participant has finished eating
|
At each of four lunch sessions conducted once per week over four weeks
|
|
Liking of vegetable + potato dishes
Time Frame: Once at start of study
|
Children will be presented with small samples of several vegetable, potato, and vegetable + potato dishes and asked to taste them.
Children will rate each food as 'yummy', 'just ok', or 'yucky' using a pictorial scale.
We will compare the percentage of children who rate the vegetable with potato (VEG+POT) dishes as yummy to the percentage that rated the same non-potato vegetable alone (VEG) as 'yummy'.
|
Once at start of study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Willingness to taste vegetable + potato dishes
Time Frame: Once at beginning of study
|
Children will be presented with small samples of several vegetable, potato, and vegetable + potato dishes and asked to taste them.
Children will rate each food as 'yummy', 'just ok', or 'yucky' using a pictorial scale.
We will compare the percentage of children who were willing to taste the vegetable with potato (VEG+POT) dishes to the percentage that were willing to taste the same non-potato vegetable alone (VEG).
|
Once at beginning of study
|
|
Intake of potatoes at lunch
Time Frame: At each of four lunch sessions conducted once per week over four weeks
|
Intake of the potato dish will be measured at each lunch session by weighing the food dish prior to serving and after the participant has finished eating
|
At each of four lunch sessions conducted once per week over four weeks
|
|
Total vegetable intake at lunch
Time Frame: At each of four lunch sessions conducted once per week over four weeks
|
Total intake of potato and non-potato vegetables will be measured at each lunch session by weighing the food dishes prior to serving and after the participant has finished eating
|
At each of four lunch sessions conducted once per week over four weeks
|
|
Total energy intake at lunch
Time Frame: At each of four lunch sessions conducted once per week over four weeks
|
Total energy intake in kcal will be measured at each lunch session by weighing the food dishes prior to serving and after the participant has finished eating
|
At each of four lunch sessions conducted once per week over four weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emily E Hohman, PhD, Penn State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00027376
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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