Míranos! Program, a Preschool Obesity Prevention RCT

• ClinicalTrials.gov Identifier: NCT03590834
• Recruitment Status: Unknown
• First Posted: July 18, 2018
• Last Update Posted: February 6, 2020
• Sponsor: The University of Texas at San Antonio
• Collaborators: University of Texas at Austin; University of Maryland, College Park; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Family Service Association of San Antonio Inc.; Parent/Child Incorporated (PCI) of San Antonio and Bexar County
• Information provided by (Responsible Party): The University of Texas at San Antonio

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Healthy Eating; Physical Activity; Health Knowledge, Attitudes, Practice; Gross Motor Development	Behavioral: Center-based Intervention; Behavioral: Home-based Intervention; Behavioral: Active Control	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 525 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: The parents of the children were informed that their Head Start center will be randomly assigned to one of the three study groups.
• Primary Purpose: Prevention
• Official Title: Obesity Prevention in Head Start: Míranos! Program
• Actual Study Start Date: August 1, 2018
• Estimated Primary Completion Date: August 2020
• Estimated Study Completion Date: August 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Center-based intervention; In-person, child-focused intervention taking place only at the Head Start centers	Behavioral: Center-based Intervention; Center nutrition and physical activity policy modification to increase fruit and vegetable servings and more physical activity throughout the day; Staff training and technical assistance; Health education on healthy habits (diet, physical activity, sleep, screen time) using the Sesame Workshop Healthy Habits for Life (HHL) resource kit; Health contests; Gross motor and physical activity program; Miranos! activity cards based on children storybooks; Other Name: CBI
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.	Behavioral: Home-based Intervention; 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.; Three Home Visits delivered by Head Start staff. Obesity prevention goal-setting integrated into existing Head Start home visits; 16 semi-monthly, Family Newsletters with stories, tips, and strategies to promote healthy habits for preschool children; Incorporating activities related to PA, nutrition and sleep into existing Head Start Center Summer Calendars; Other Name: C+HBI
Active Comparator: Active Control; Active comparison group	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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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
2. 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
3. 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.
4. 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
5. 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.
6. 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.

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 5 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Texas

University of Texas at San Antonio

San Antonio, Texas, United States, 78249

Sponsors and Collaborators

The University of Texas at San Antonio

University of Texas at Austin

University of Maryland, College Park

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

Family Service Association of San Antonio Inc.

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

Investigators

• Principal Investigator: Zenong Yin, PhD; University of Texas at San Antonio
• Principal Investigator: Deborah Parra-Medina, PhD; University of Texas at Austin

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 "¡Míranos! 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.

• Responsible Party: The University of Texas at San Antonio
• ClinicalTrials.gov Identifier: NCT03590834
• Other Study ID Numbers: R01DK109323 ( U.S. NIH Grant/Contract ); R01DK109323 ( U.S. NIH Grant/Contract )
• First Posted: July 18, 2018
• Last Update Posted: February 6, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All IPD collected will be shared
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight