Yin 2019a.

Trial name or title	Study name: ¡Míranos! Look at Us, We Are Healthy!
Methods	Study design: cluster‐randomized controlled trial Study grouping: parallel group Study aim: this study “will use a cluster randomized controlled design to test the efficacy of the ¡Míranos! intervention in preventing excessive weight gain and promoting the development of healthy habits in young children enrolled in Head Start" (quote) Study period: May 2018 to August 2021 (estimated) Total number of arms: 3 Description of intervention arms: 1. Combined center‐ and home‐based intervention (child + caregiver); 2. Center‐based intervention (child only); 3. Attention control arm offering Head Start−endorsed obesity prevention curriculum (not eligible) Number of clusters per arm: 4 Average cluster size: 37 (estimated) Sample size justification and outcome used: study authors based power calculations on data from a previous study with a similar center‐based intervention and home‐based intervention components. For the present study, study authors reported that “a sample size of 12 centers (i.e., 4 centers/group) with 29 children per center” (quote) was needed to detect a difference between the child + caregiver and child‐only arms and the attention control arm of 0.53 BMI units at a power of 80% and a 5% probability of a type 1 error, assuming an ICC of 0.003 and SD = 1.147. “The final sample size was increased to 37 (> 29/0.8) children per center (i.e. 37 × 12 = 444 children in total) to account for an attrition rate of 80%” (quote). Unit of allocation: Head Start center Missing data handling: study authors reported that participants with missing data will be compared with participants with complete data to assess any differences in demographic and outcome measures, using available data. If data are missing at random (MAR), standard computational algorithms will be used to generate appropriate parameter estimates using all available data. If the MAR assumption is in doubt, missing data will be imputed using the multiple imputations with chained equations approach. Specifically, missing values will be imputed by adjusting for time of measurement and demographics to create 10 imputed data sets. Effect sizes then will be combined using the Rubin’s rules Reported limitations: 1. Head Start staff will not be blinded to treatment assignment; 2. Data collection staff will not be blinded to treatment assignment Randomization ratio and stratification: 1:1:1; stratified by the organization overseeing each center and center enrollment size Participant compensation or incentives: to increase parental participation and compliance, incentives (up to USD 30) will be provided for completing daily logs (USD 3 per day) and parent surveys (USD 9 and raffles for a tricycle); staff members will receive cash incentives for their centers by participating in center‐wide wellness challenges
Participants	Baseline characteristics: not known Recruitment methods: Head Start centers were selected from 2 organizations that joined the study as collaborators. Twelve centers were determined to meet the eligibility criteria and have been randomly assigned to 1 of the 3 treatment conditions (3 centers from organization A and 9 centers from organization B). Recruitment packets will be sent home with eligible children from each participating center. Children will receive a coloring book if their parents return a signed consent form agreeing or declining to participate in the study Inclusion criteria: clusters: full‐day center (more than 7 hours of care per day), at least 1 classroom enrolling children aged 3, agreement to modify center physical activity and nutrition policies, agreement not to participate in other health‐related studies; participants: child enrolled in a participating center, aged 3 years at baseline, parental consent, 1 child per family Exclusion criteria: not known Age of participating children at baseline: 3 years Total number randomized by relevant group: total number of children randomized by relevant group has not yet been reported; however, study authors note that they anticipate recruiting 444 children and their parents Baseline imbalances between relevant groups: not known Total number analyzed by relevant group: not known Attrition by relevant group: not known Description of sample for baseline characteristics reported above: not relevant
Interventions	Intervention characteristics Child + caregiver arm (intervention group) Brief name/description (TIDieR #1): center‐based intervention plus a home‐based intervention designed to engage parents Focus of intervention: diet and physical activity Behavior change techniques: in addition to the child‐only intervention, the following technique was applied separately or differently in the child + caregiver arm: "goals and planning," "social support," "shaping knowledge," "comparison of behavior," "repetition and substitution," "reward and threat" Why: rationale, theory, or goal (TIDieR #2): same as child‐only arm How, where, and when and how much (TIDieR #6 to 8): in addition to the child‐only arm, parents will receive 8 monthly peer‐led education sessions during child pick‐up time (15 to 20 minutes per session). Parents will be asked to complete a “Family Health Challenge” in the week following each educational session (n = 8). They will receive 16 biweekly health newsletters and 3 home visits Who: providers (TIDieR #5): trained Head Start parents will deliver the educational sessions; home visits will be conducted by trained family service workers Economic variables and resources required for replication: not known; cost‐effectiveness analysis is planned to estimate program delivery costs Strategies to address disadvantage: focus on low‐income, predominantly Latino preschool children Subgroups: not known Assessment time points: baseline, 8 months (end of intervention), 21 months (1‐year post‐intervention follow‐up) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): tailoring (TIDieR #9): in addition to the child‐only arm, peer‐led education sessions will focus on evidence‐based strategies related to positive child feeding, increasing PA and sleep duration, reducing screen time at home, limiting sugary drinks, and promoting water. Parents will receive take‐home bags after each educational session containing a health‐themed storybook, a bilingual family activities newsletter, an interactive game, and a “Family Health Challenge” form. Newsletters will provide tips on modifying family health behaviors, healthy snack and meal recipes, and information on community resources to promote healthier lifestyles. Family health challenges will focus on a targeted health behavior (e.g. drinking water); parents will be able to choose 1 of 3 challenges to complete over 7 days Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known; however, process evaluation is planned Sensitivity analyses: not known Child‐only arm (control group) Brief name/description (TIDieR #1): center‐based intervention designed to enhance PA opportunities, reduce sedentary time, and promote healthy eating Focus of intervention: diet and physical activity Behavior change techniques: "goals and planning," "shaping knowledge," "comparison of behavior," "repetition and substitution" Why: rationale, theory, or goal (TIDieR #2): the intervention program was based on theories of early child development, social cognitive theory, and socioecological models and was informed by a systems approach. Intervention components were culturally tailored for Latino preschoolers and their parents. The program was designed to develop long‐term health habits by targeting energy‐balance related behaviors among low‐income predominantly Latino preschool children, who are at higher risk for obesity than non‐Latino children How, where, and when and how much (TIDieR #6 to 8): physical activity and nutrition policies will be implemented across all intervention centers during the 7‐month intervention period. Children will participate in daily PA (30 minutes of structured and 60 minutes of non‐structured play) during outdoor/indoor play sessions, learning center time, and transitions. Children will also participate in health education activities at least twice weekly Who: providers (TIDieR #5): center‐based intervention activities will be delivered by trained Head Start teachers Economic variables and resources required for replication: not known; cost‐effectiveness analysis is planned to estimate program delivery costs Strategies to address disadvantage: focus on low‐income, predominantly Latino preschool children Subgroups: not known Assessment time points: baseline, 8 months (end of intervention), 21 months (1‐year post‐intervention follow‐up) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): physical activity policies will focus on offering 90 minutes of teacher‐led physical activity to children every day. Nutrition polices will focus on offering balanced healthy meals and snacks utilizing the USDA Child and Adult Care Food Program best practice recommendations. Teachers will meet children’s daily PA goals using Activity Cards, active learning activities that combine literacy and numeracy skills with physical activities, and music CDs and dance videos. Health education activities will be based on the Healthy Habits for Life (HHL) resource kit. The HHL uses Sesame Street characters to promote PA and healthy eating and consists of 9 modules with short learning activities, hands‐on games, and interactive DVD activities Tailoring (TIDieR #9): not known Modifications (TIDieR #10): not known How well: planned and actual (TIDieR #11 to 12): not known; however, process evaluation is planned Sensitivity analyses: not known
Outcomes	The following instruments are being used to measure outcomes relevant to this review at baseline, 8 months (end of intervention), and 21 months (1‐year post‐intervention follow‐up) Children's dietary intake: NHANES dietary screener completed by parents; aggregated plate waste tests Study authors report that dietary screener data will be used to assess fruit intake, vegetable intake, and beverage intake; intake at childcare centers will also be assessed through aggregated plate waste Children's physical activity levels and sedentary behavior: objective measurement with 7 days of accelerometry (specific instrument not reported) and parent‐report measurement of screen time using a 7‐day log Study authors report that accelerometry data will be used to calculate minutes of light, moderate, and vigorous physical activity, and sedentary activity, and the parent‐report log will be used to track the time that the child spends watching TV/DVD Children’s anthropometry: height and weight measured twice at the beginning of the school day with no shoes and light clothes, using a stadiometer and a digital weight scale (specific instruments not reported) Study authors report that BMI, BMI percentile, and zBMI for age and gender will be calculated using the average of the 2 measures‐based CDC growth charts Caregivers' dietary intake: self‐reported; measurement tool not reported Study authors do not report the specific diet outcomes that will be calculated Caregivers’ physical activity levels: self‐reported; measurement tool not reported Study authors do not report specific physical activity outcomes that will be calculated
Starting date	The study began in May 2018, and the trial was registered on July 18, 2018
Contact information	Author's name: Zenong Yin Email: zenong.yin@utsa.edu
Notes	Country: USA Setting: Head Start centers in San Antonio, Texas Types of reports: published protocol; trial registration Comments: used the following reports: (1) Yin 2019, and (2) trial registration (Clinicaltrials.gov registration number NCT03590834) Conflicts of interest: "the authors declare that they have no competing interests" (quote) Sponsorship source: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, under award number R01DK109323

BCT: behavior change technique.

BMI: body mass index.

CDC: Centers for Disease Control and Prevention.

FFQ: food frequency questionnaire.

GPAQ: Global Physical Activity Questionnaire.

ICC: intracluster correlation coefficient.

IPAQ: International Physical Activity Questionnaire.

MAR: missing at random.

MVPA: moderate to vigorous physical activity.

NHANES: National Health and Nutrition Examination Survey.

PA: physical activity.

SD: standard deviation.

SMS: short message service.

SSB: sugar‐sweetened beverage.

TIDieR: Template for Intervention Description and Replication.

WHO: World Health Organization.