Míranos! Program, a Preschool Obesity Prevention RCT

Summary

The prevalence of obesity remains high in American children aged 2-5 while one in three Head Start children is overweight or obese. The proposed study is designed to test the efficacy of an early childhood obesity prevention program which promotes healthy growth in predominantly Latino children in Head Start.

The program is a group clustered randomized controlled trial in partnership with two local Head Start organizations to address key enablers and barriers in obesity prevention in young children. The study has three specific aims:

1. To test the efficacy of the Miranos! intervention on healthy weight growth (primary outcome) in normal weight, overweight, and obese children.
2. To test the impact of the Miranos! intervention on children's physical activity, sedentary behavior, sleep, and dietary behaviors (secondary outcomes).
3. To evaluate cost-effectiveness of the Miranos! intervention.

Miranos! will be delivered in Fall and Spring (8 months) and followed by a summer health campaign.

Conditions

• Obesity
• Healthy Eating
• Physical Activity
• Health Knowledge, Attitudes, Practice
• Gross Motor Development

Interventions

BEHAVIORAL

Center-based Intervention

1. Center nutrition and physical activity policy modification to increase fruit and vegetable servings and more physical activity throughout the day 2. Staff training and technical assistance 3. Health education on healthy habits (diet, physical activity, sleep, screen time) using the Sesame Workshop Healthy Habits for Life (HHL) resource kit 4. Health contests 5. Gross motor and physical activity program 6. Miranos! activity cards based on children storybooks

BEHAVIORAL

Home-based Intervention

1. Monthly interactive poster education sessions led by parent peer educators during child pick-up time. Held at Head Start Center. These sessions include family health challenges and take-home activities. 2. Three Home Visits delivered by Head Start staff. Obesity prevention goal-setting integrated into existing Head Start home visits 3. 16 semi-monthly, Family Newsletters with stories, tips, and strategies to promote healthy habits for preschool children 4. Incorporating activities related to PA, nutrition and sleep into existing Head Start Center Summer Calendars

BEHAVIORAL

Active Control

Children will receive Head-Start-approved health education program for children: "I Am Moving, I Am Learning". In addition, the investigators will deliver an early childhood literacy program to all active control children to increase buy-in and retention.

Sponsors & Collaborators

• University of Texas at Austin

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Family Service Association of San Antonio Inc.

  collaborator UNKNOWN

• Parent/Child Incorporated (PCI) of San Antonio and Bexar County

  collaborator UNKNOWN

• The University of Texas at San Antonio

  lead OTHER

Principal Investigators

• Zenong Yin, PhD · University of Texas at San Antonio

• Deborah Parra-Medina, PhD · University of Texas at Austin

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

5 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-08-01

Primary Completion

2021-08-31

Completion

2023-08-31

Countries

• United States

Study Locations