ObesityNCT03590834
Míranos! Program, a Preschool Obesity Prevention RCT
A study testing Center-based Intervention and Home-based Intervention in people with Obesity and Healthy Eating, run by The University of Texas at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Healthy Eating, Physical Activity
- What is being tested?
- Center-based Intervention and Home-based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at San Antonio
San Antonio, Texas, 78249
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Obesity, Healthy Eating, Physical Activity, Health Knowledge, Attitudes, Practice, Gross Motor Development
- Being tested
- Center-based Intervention, Home-based Intervention, Active Control
- Medical subject headings
- Obesity, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Center-based InterventionBehavioural
Also called CBI
- 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
Home-based InterventionBehavioural
Also called C+HBI
- 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
Active ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Center-based intervention | Experimental | In-person, child-focused intervention taking place only at the Head Start centers Receives: 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. Receives: Behavioral: Home-based Intervention |
| Active Control | Active comparator | Active comparison group Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 months, 21 months
Secondary outcomes (6)
Change in Physical Activity, Sedentary Activity, and Sleep
7-d accelerometry to measure the minutes of light-, moderate- and vigorous-intensity physical activity, sedentary activity, and sleep/day
Measured: Baseline, 8 months, 21 months
Change in Parent report of screen time and sleep
7-d parent log to track time that child spends watching TV/DVD and sleeping each day
Measured: Baseline, 8 months, 21 months
Change in Fruit, vegetable, and beverage consumption
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.
Measured: Baseline, 8 months, 21 months
Change in Food preference
A computer-assisted pictorial test to measure young children's preferences for healthy food
Measured: Baseline, 8 months, 21 months
Change in Parent Behavior
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.
Measured: Baseline, 8 months, 21 months
Demographic Information
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start1 Aug 2018
- Primary completion31 Aug 2021
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin, University of Maryland, 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
- Responsible party
- Sponsor
- Investigators
- Zenong Yin, PhD, Principal investigator, University of Texas at San AntonioDeborah Parra-Medina, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590834
- Sponsor's protocol ID
- R01DK109323
- Other IDs
- R01DK109323
- Status last verified
- Nov 2023
- First submitted
- 27 Jun 2018
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected will be shared
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.
PubMed 31179916Ullevig 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.
PubMed 36944986Yin 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.
PubMed 36357340
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity Prevention in Head Start: Míranos! Program
- ClinicalTrials.gov ID
- NCT03590834
- Acronym / sponsor ID
- R01DK109323
- Conditions
- Obesity, Healthy Eating, Physical Activity, Health Knowledge, Attitudes, Practice, Gross Motor Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- The University of Texas at San AntonioUniversity, hospital or other
- Collaborators
- University of Texas at Austin, University of Maryland, 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
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Center-based intervention | Experimental | Behavioral: Center-based InterventionIn-person, child-focused intervention taking place only at the Head Start centers |
| Center-and-home-based intervention | Experimental | Behavioral: Home-based InterventionIn-person, child-focused intervention taking place only at the Head Start centers. Delivered in-person at Head Start centers and the family home. |
| Active Control | Active comparator | Behavioral: Active ControlActive comparison group |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Center-based InterventionAlso: CBI1. 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 | Behavioural | Center-based intervention |
| Home-based InterventionAlso: C+HBI1. 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 | Behavioural | Center-and-home-based intervention |
| Active ControlChildren 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. | Behavioural | Active Control |
Primary outcome
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.
6 secondary outcomes
Change in Physical Activity, Sedentary Activity, and Sleep
Time frame: Baseline, 8 months, 21 months
Change in Parent report of screen time and sleep
Time frame: Baseline, 8 months, 21 months
Change in Fruit, vegetable, and beverage consumption
Time frame: Baseline, 8 months, 21 months
Change in Food preference
Time frame: Baseline, 8 months, 21 months
Change in Parent Behavior
Time frame: Baseline, 8 months, 21 months
Demographic Information
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Background: PubMed 31179916Yin 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.
- Background: PubMed 36944986Ullevig 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.
- Background: PubMed 36357340Yin 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.
- Individual participant dataSharing planned: Yes. All IPD collected will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zenong Yin, PhD principal investigator
University of Texas at San Antonio
Deborah Parra-Medina, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Center-based Intervention and Home-based Intervention in people with Obesity and Healthy Eating, run by The University of Texas at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (time frame: Baseline, 8 months, 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03590834, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.