Míranos! Program, a Preschool Obesity Prevention RCT

NCT03590834 | Completed

• 1 other identifier: R01DK109323
• Study Type: interventional
• Target: 525
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index

  Child's height and weight will be measured twice with no shoes and light clothing in an area separated by a privacy screen, using a stadiometer and digital weight scale. Discrepancy between the two measures must be ≤0.2 cm and≤ 0.10 kg. BMI, BMI-percentile, and zBMI for age and gender will be calculated using the average of the two measures based CDC Growth Charts.

  Baseline, 8 months, 21 months

Secondary Outcomes (6)

• Change in Physical Activity, Sedentary Activity, and Sleep

  Baseline, 8 months, 21 months

• Change in Parent report of screen time and sleep

  Baseline, 8 months, 21 months

• Change in Fruit, vegetable, and beverage consumption

  Baseline, 8 months, 21 months

• Change in Food preference

  Baseline, 8 months, 21 months

• Change in Parent Behavior

  Baseline, 8 months, 21 months

Study Arms (3)

Center-based intervention

EXPERIMENTAL

In-person, child-focused intervention taking place only at the Head Start centers

Behavioral: Center-based Intervention

Center-and-home-based intervention

EXPERIMENTAL

In-person, child-focused intervention taking place only at the Head Start centers. Delivered in-person at Head Start centers and the family home.

Behavioral: Home-based Intervention

Active Control

ACTIVE COMPARATOR

Active comparison group

Behavioral: Active Control

Interventions

Center-based Intervention BEHAVIORAL

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

Also known as: CBI

Center-based intervention

Home-based Intervention BEHAVIORAL

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

Also known as: C+HBI

Center-and-home-based intervention

Active Control BEHAVIORAL

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.

Active Control

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child must be enrolled in a full-day Head Start center
• The child must be 3 years old at baseline, one child per family, parental consent

You may not qualify if:

• N/A

Sponsors & Collaborators

• The University of Texas at San Antonio: lead
• University of Texas at Austin: collaborator
• University of Maryland: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Family Service Association of San Antonio Inc.: collaborator
• Parent/Child Incorporated (PCI) of San Antonio and Bexar County: collaborator

Study Sites (1)

University of Texas at San Antonio

San Antonio, Texas, 78249, United States

Location

Related Publications (3)

• Yin Z, Ullevig SL, Sosa E, Liang Y, Olmstead T, Howard JT, Errisuriz VL, Estrada VM, Martinez CE, He M, Small S, Schoenmakers C, Parra-Medina D. Study protocol for a cluster randomized controlled trial to test " inverted exclamation markMiranos! Look at Us, We Are Healthy!" - an early childhood obesity prevention program. BMC Pediatr. 2019 Jun 10;19(1):190. doi: 10.1186/s12887-019-1541-4.

  PMID: 31179916 BACKGROUND

• Ullevig SL, Parra-Medina D, Liang Y, Howard J, Sosa E, Estrada-Coats VM, Errisuriz V, Li S, Yin Z. Impact of inverted exclamation markMiranos! on parent-reported home-based healthy energy balance-related behaviors in low-income Latino preschool children: a clustered randomized controlled trial. Int J Behav Nutr Phys Act. 2023 Mar 21;20(1):33. doi: 10.1186/s12966-023-01427-z.

  PMID: 36944986 BACKGROUND

• Yin Z, Liang Y, Howard JT, Errisuriz V, Estrada VM, Martinez C, Li S, Ullevig SL, Sosa E, Olmstead T, Small S, Ward DS, Parra-Medina D. inverted exclamation markMiranos! a comprehensive preschool obesity prevention programme in low-income Latino children: 1-year results of a clustered randomised controlled trial. Public Health Nutr. 2023 Feb;26(2):476-487. doi: 10.1017/S1368980022002439. Epub 2022 Nov 11.

  PMID: 36357340 BACKGROUND

MeSH Terms

Conditions

Obesity; Motor Activity; Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zenong Yin, PhD

  University of Texas at San Antonio

  PRINCIPAL INVESTIGATOR

• Deborah Parra-Medina, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The parents of the children were informed that their Head Start center will be randomly assigned to one of the three study groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 18, 2018
• Study Start: August 1, 2018
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available after data has been analyzed for primary and secondary outcome measures
• Access Criteria: Data will be made available for research educational purposes.

Locations

US (1)