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. 2020 Feb 10;2020(2):CD011779. doi: 10.1002/14651858.CD011779.pub3

Esquivel 2016.

Methods Study design: Intervention trial within a larger RCT
Intervention duration: 7 months
Length of follow‐up from baseline: 1 year
Differences in baseline characteristics: reported
Unit of allocation: childcare service
Unit of analysis: childcare service
Participants Service type: centre
Region: 2 communities on O’ahu, Hawaii
Demographic/socioeconomic characteristics: Head Start (HS) is a federally funded preschool programme serving low‐income children aged 3–5 years within remote underserved minority populations in the Pacific region.
Inclusion/exclusion criteria: Not described
Number of services randomised: 23 centres
Numbers by trial group:
n (controls baseline) = 12
n (controls follow‐up) = 11
n (interventions baseline) = 12
n (interventions follow‐up) = 11
Recruitment:
Service: This research was embedded within the randomised community trial, the Children's Healthy Living Program for Remote Underserved Minority Populations in the Pacific Region. Total of 23 HS classrooms from 18 HS joined the study.
Child: Child sample included 349 children from the 23 classes from 18 centres (n = 173 intervention, n = 176 delayed intervention).
Recruitment rate: not reported
Interventions Number of experimental conditions: 2 (intervention, waiting‐list control)
Policies, practices or programmes targeted by the intervention:
‐ Nutrition and physical activity environment
‐ Meal service style and types of foods and beverages served teachers in implementing wellness policies to promote nutrition and PA in their classrooms
‐ To affect multiple contributing factors to the availability of foods high in sugar and fat, classroom activities and practices, and social norms.
Implementation strategies:
Educational materials: Classroom resources from the Healthy Habits for Life curriculum
Educational meetings: Training and technical assistance
Other: Monthly employee wellness activities that reinforced their role as models for healthy eating and PA in the classroom
Who delivered the intervention: Staff members for policy component, but unclear for staff health component
Theoretical underpinning: Social ecological model
Description of control: Waiting‐list control (delayed intervention)
Outcomes Outcome relating to the implementation of childcare service policies, practices or programmes:
Nutrition and physical activity environment of the classroom as a result of policy:
Data collection method: Environment and Policy Assessment and Observations (EPAO) of the classroom environment
Validity of measures used: EPAO is a validated tool.
Outcome relating to cost: not applicable
Outcome relating to adverse consequences: not applicable
Outcome relating to child diet, physical activity or weight status:
Child BMI:
Data collection method: Child height was measured by a stadiometer to the nearest 0.1 cm. Child weight was measured using a portable scales to the nearest 0.1 kg. BMI was calculated using the measured mean height and weight.
Validity of measures used: Child BMI variables were calculated based on 2000 CDC Growth Charts, BMI for Age and Sex. zBMI and change in zBMI over the programme year were calculated to measure change in BMI status, adjusting for age and sex.
Child dietary intake:
Data collection method: Dietary intake of children was assessed by observed plate waste, as recommended by the IOM’s plan for measuring obesity prevention efforts.
Validity of measures used: not reported
Outcome relating to implementation strategy acceptability, adoption, penetration, sustainability and appropriateness: not applicable
Notes This project was supported by the Agriculture and Food Research Initiative, Grant No. 2011‐68001‐30335 from the USA Department of Agriculture, National institute of Food and Agricultural Science Enhancement Coordinated Agricultural Program.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The random sequence generation procedure was not described.
Allocation concealment (selection bias) Unclear risk There was no information provided about allocation concealment and therefore it was unclear if allocation was concealed.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Environment and Policy Assessment and Observation (EPAO). Although the assessor was blinded, there was no mention that the participants were blinded and therefore there was a high risk of performance bias.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Environment and Policy Assessment and Observation (EPAO). The EPAOs were completed by graduate student interns who were blinded to the study arm of the classrooms being observed.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk There was no attrition for the EPAOs (this was completed for all 23 classrooms).
Selective reporting (reporting bias) Unclear risk The Wilkin protocol paper was for the main study and the research reported by Equivel was embedded within it. The Wilkin protocol paper may not have intended to report the outcomes for the embedded research and therefore it was unclear whether there was selective outcome reporting.