Increasing Vegetable Intake in Children

Baylor College of Medicine

Status: Completed

Conditions: Behavior; Food Habits; Obesity

Treatments: Behavioral: Increase vegetable intake in pre-school children

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02216968

1R21HD073608-01A1 (U.S. NIH Grant/Contract)

H-30554

Details and patient eligibility

About

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).

Full description

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).The primary endpoint will be changes in V consumption in high school children with the hypothesis that a puppet intervention will increase their V consumption by preschool children. To achieve the project goal, our specific aims (SA) are to: SA1: Successfully recruit 6 preschool (PS) centers and 168 AA and 168 HA children 3 to 5 y enrolled there. SA2: Conduct individual interviews for formative assessment of the PUPPET shows. SA3: Develop the manual of operation and intervention protocols SA4: Develop 4 videotaped theatre-based PUPPET shows that are developmentally and cognitively appropriate for use with 3- to 5-year-old AA and HA children SA5: Pilot-test the feasibility of the PUPPET intervention with 3 intervention and 3 control HS centers. SA6: Use the data collected in Aim 5 to estimate parameters required to conduct a group randomized trial for an evaluation of the efficacy of the intervention. The primary hypothesis (H1) to be tested is that children who receive the PUPPET intervention will demonstrate increased V consumption in HS compared to children in the control group.

Enrollment: 600 estimated patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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600 participants in 2 patient groups

AA - Increase vegetable intake

Experimental group

Description:

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".

Treatment:

Behavioral: Increase vegetable intake in pre-school children

HA - Increase vegetable intake

Experimental group

Description:

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".

Treatment:

Behavioral: Increase vegetable intake in pre-school children