NCT02216968

Brief Summary

The purpose of this study is to test the feasibility of an innovative approach to increase the amount of vegetable's (V) intake consumed by preschool children who are predominately African-American (AA) and Hispanic-American (HA).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 12, 2017

Status Verified

July 1, 2017

Enrollment Period

4.4 years

First QC Date

August 6, 2014

Last Update Submit

July 11, 2017

Conditions

Keywords

vegetablesHead Startpreschoolchildrentheaterpuppet

Outcome Measures

Primary Outcomes (1)

  • Vegetable Intake in Preschool Children

    There will be 2 phases to program development: diagnostic and formative. The diagnostic phase will consist of 20 individual interviews with child-care providers and parents (½ AA, ½ HA) and 20 interviews with preschool children (½ AA, ½ HA).In addition the parents will be asked to complete the Cooking Confidence Questionnaire, the Barriers and Facilitators Questionnaire on Vegetables and a list of their child's favorite vegetables before coming to the interview. Implementation will include the showing of the 4 video-taped puppet shows to 10-12 children immediately prior to the lunch meal on 4 consecutive days. These children will be assessed at lunch using the digital diet estimation method.

    1 year 11 months

Study Arms (2)

AA - Increase vegetable intake

EXPERIMENTAL

60 African-American (AA) preschool children will participate in the Intervention Group. 60 AA children will belong to the Control Group. 6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate "increase vegetable intake in pre-school children".

Behavioral: Increase vegetable intake in pre-school children

HA - Increase vegetable intake

EXPERIMENTAL

60 Hispanic-American (HA) preschool children will participate in the Intervention Group. 60 HA children will belong to the Control Group. 6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate "increase vegetable intake in pre-school children".

Behavioral: Increase vegetable intake in pre-school children

Interventions

6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate "increase vegetable intake in pre-school children".

AA - Increase vegetable intakeHA - Increase vegetable intake

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy
  • non-patient
  • normals
  • African-american
  • Hispanic-american
  • to 5 y olds

You may not qualify if:

  • pregnant woman
  • neonates
  • dietary restrictions
  • chronic disease
  • developmental disabilities
  • special education
  • does not read or write in spanish or english

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Nicklas T, Lopez S, Liu Y, Saab R, Reiher R. Motivational theater to increase consumption of vegetable dishes by preschool children. Int J Behav Nutr Phys Act. 2017 Feb 7;14(1):16. doi: 10.1186/s12966-017-0468-0.

MeSH Terms

Conditions

ObesityBehaviorFeeding Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, Animal

Study Officials

  • Theresa A Nicklas, DrPH

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2014

First Posted

August 15, 2014

Study Start

July 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 12, 2017

Record last verified: 2017-07

Locations