Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
525 participants
INTERVENTIONAL
2018-08-01
2023-08-31
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Center-based intervention
In-person, child-focused intervention taking place only at the Head Start centers
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
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.
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
Active Control
Active comparison group
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.
Interventions
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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
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The child must be 3 years old at baseline, one child per family, parental consent
Exclusion Criteria
3 Years
5 Years
ALL
Yes
Sponsors
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University of Texas at Austin
OTHER
University of Maryland
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Family Service Association of San Antonio Inc.
UNKNOWN
Parent/Child Incorporated (PCI) of San Antonio and Bexar County
UNKNOWN
The University of Texas at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Zenong Yin, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas at San Antonio
Deborah Parra-Medina, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas at Austin
Locations
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University of Texas at San Antonio
San Antonio, Texas, United States
Countries
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References
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