Clinical trial NCT03590834: Míranos! Program, a Preschool Obesity Prevention RCT
Official title: Obesity Prevention in Head Start: Míranos! Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Healthy Eating
Physical Activity
Health Knowledge, Attitudes, Practice
Gross Motor Development
Lead sponsor: The University of Texas at San Antonio
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
name: University of Maryland
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Family Service Association of San Antonio Inc.
name: Parent/Child Incorporated (PCI) of San Antonio and Bexar County
First posted: 2018-07-18
Enrollment: 525
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. 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.

Detailed description: Using a three-arm design, 12 Head Start (HS) centers in equal number will be randomly assigned to one of three conditions: 1) a combined center- and home-based intervention, 2) center-based intervention only, or 3) active control. The interventions will be delivered during the academic year (an 8-month \[mo\] period). A total of 525 3-year-old children (52% females; in two cohorts) will be enrolled in the study at baseline and followed prospectively one-year post-intervention. The first cohort will be recruited in summer 2018. The second cohort will be recruited in summer 2019.

Data collection will be conducted at baseline (T0), immediate post-intervention (T1), and 1-year post-intervention follow-up (T2) and include children's height, weight, accelerometry-based PA and sedentary behavior, TV watching and sleep by parent reports, gross motor development, dietary intakes, food preference. Information on family background, parental PA- and nutrition-related practices, parental weight and health behaviors, PA and nutrition policies and environments at the center and home, and costs associated with intervention delivery will be collected. The primary endpoint for the study is the BMI at the posttest immediately following the completion of the intervention (T1).

Recruitment: Participant recruitment will take place during summer by sending a recruitment packet to child's home. This packet includes: study information sheet, recruitment flyer, informed consent form, a letter from center director and study PIs.

Process Evaluation: The process evaluation is informed by the NIH Behavior Change Consortium Treatment Fidelity Workgroup's best practice recommendations and recent multi-component RCTs. Míranos! has multiple components with multiple activities, the investigators will use many indicators to evaluate the fidelity and completeness of the implementation of all components and determine contribution of each component by linking it to the primary and secondary outcomes. The investigators will collect both quantitative/qualitative data to assess cross-site treatment consistency, non-treatment-related effects, and document protocol changes.

First, intervention dose delivered will be measured by: 1) pre-/post-study center environmental assessment by the Environment and Policy Assessment and Observations (EPAO) and auditing of meal menus; 2) completion of delivery schedule of staff, peer leader training, parent education sessions, home visits; 3) evaluation of staff, peer leader training; 4) monthly auditing of weekly lesson plans; and 5) monthly checklist of use of Míranos! Activity Cards, children's story books, HHL learning activities.

Second, the intervention dose received will be assessed by: 1) attendance records of staff, peer leader training, parent education sessions; 2) certification test of staff, peer leader training; 3) monthly staff evaluation (rating scale) of children's learning of HHL content, gross motor skills, eating behaviors; 4) post-study parent intercept interviews; and 5) post-study focus groups on program delivery process with staff (n=24) and parents (n=32).

Third, participants' responses to the intervention will be evaluated by: 1) random observations of staff behavior (rating scale) during outdoor play and lunch by research staff; 2) assessments on children's PA by the System for Observing Fitness Instruction Time for Preschoolers and diet by group plate waste test in 3 randomly selected centers; 3) in-depth interviews with staff (n=48) for program feedback; and 4) post-study staff and parent evaluation (rating scale) of satisfaction with intervention components/activities.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Change in Body Mass Index
timeFrame: Baseline, 8 months, 21 months
Secondary outcomes:
measure: Change in Physical Activity, Sedentary Activity, and Sleep
timeFrame: Baseline, 8 months, 21 months
measure: Change in Parent report of screen time and sleep
timeFrame: Baseline, 8 months, 21 months
measure: Change in Fruit, vegetable, and beverage consumption
timeFrame: Baseline, 8 months, 21 months
measure: Change in Food preference
timeFrame: Baseline, 8 months, 21 months
measure: Change in Parent Behavior
timeFrame: Baseline, 8 months, 21 months
measure: Demographic Information
timeFrame: Baseline
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas at San Antonio
state: Texas
Study officials:
affiliation: University of Texas at San Antonio
name: Zenong Yin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas at Austin
name: Deborah Parra-Medina, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.