- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03590834
Míranos! Program, a Preschool Obesity Prevention RCT
Obesity Prevention in Head Start: Míranos! Program
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:
- To test the efficacy of the Miranos! intervention on healthy weight growth (primary outcome) in normal weight, overweight, and obese children.
- To test the impact of the Miranos! intervention on children's physical activity, sedentary behavior, sleep, and dietary behaviors (secondary outcomes).
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78249
- University of Texas at San Antonio
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Center-based intervention
In-person, child-focused intervention taking place only at the Head Start centers
|
Other Names:
|
Experimental: Center-and-home-based intervention
In-person, child-focused intervention taking place only at the Head Start centers.
Delivered in-person at Head Start centers and the family home.
|
Other Names:
|
Active Comparator: Active Control
Active comparison group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Mass Index
Time Frame: Baseline, 8 months, 21 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Physical Activity, Sedentary Activity, and Sleep
Time Frame: Baseline, 8 months, 21 months
|
7-d accelerometry to measure the minutes of light-, moderate- and vigorous-intensity physical activity, sedentary activity, and sleep/day
|
Baseline, 8 months, 21 months
|
Change in Parent report of screen time and sleep
Time Frame: Baseline, 8 months, 21 months
|
7-d parent log to track time that child spends watching TV/DVD and sleeping each day
|
Baseline, 8 months, 21 months
|
Change in Fruit, vegetable, and beverage consumption
Time Frame: Baseline, 8 months, 21 months
|
Assessment of children's consumption of fruits, vegetables and beverages by screener on the frequency and portion size of food items that will be completed by the parents as well as aggregate plate waste to asses intake at sites.
|
Baseline, 8 months, 21 months
|
Change in Food preference
Time Frame: Baseline, 8 months, 21 months
|
A computer-assisted pictorial test to measure young children's preferences for healthy food
|
Baseline, 8 months, 21 months
|
Change in Parent Behavior
Time Frame: Baseline, 8 months, 21 months
|
Parents will complete: 1) the Home Health Environment survey, 2) the Parenting Strategies for Eating and Activity Scale, 3) health knowledge assessment; and 4) parental confidence/self-efficacy scale.
|
Baseline, 8 months, 21 months
|
Demographic Information
Time Frame: Baseline
|
Information will be collected from the parents on family socioeconomic status (parent education, income, employment, health insurance, food insecurity, race/ethnicity, age, sex), acculturation (a 12-item bidirectional measure), family structure, type of residence, and family health history at baseline.
|
Baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Zenong Yin, PhD, University of Texas at San Antonio
- Principal Investigator: Deborah Parra-Medina, PhD, University of Texas at Austin
Publications and helpful links
General Publications
- 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.
- 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.
- Yin Z, Liang Y, Howard JT, Errisuriz V, Estrada VM, Martinez C, Li S, Ullevig S, Sosa E, Olmstead T, Small S, Ward DS, Parra-Medina D. inverted exclamation markMiranos! a Comprehensive Preschool Obesity Prevention Program in Low-Income Latino Children: One-year Results of a Clustered Randomized Controlled Trial. Public Health Nutr. 2022 Nov 11:1-26. doi: 10.1017/S1368980022002439. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DK109323 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Center-based Intervention
-
Université de SherbrookeActive, not recruiting
-
Stanford UniversityJohn & Marcia Goldman FoundationRecruitingAutism Spectrum Disorder | Developmental Disability | Development Delay | Development Disorder, ChildUnited States
-
Duke UniversityCompletedTreatment-Resistant HypertensionUnited States
-
VA Office of Research and DevelopmentRecruiting
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedTreatment-Resistant HypertensionUnited States
-
Stanford UniversityAnonymous DonorRecruitingAutism Spectrum Disorder | Autism | ASDUnited States
-
Stanford UniversityCompletedAutistic DisorderUnited States
-
University of Castilla-La ManchaBiomedical Research Networking Center on Frailty and Healthy Aging (CIBERFES) and other collaboratorsRecruitingHealthy | Physical Inactivity | Older AdultSpain
-
Hacettepe UniversityCompletedKnee OsteoarthritisTurkey
-
Brno University HospitalRecruitingLymphoma | Hematologic MalignancyCzechia