Swindle 2017a.

Methods	Study design: cluster‐randomized controlled trial Study grouping: parallel group Study aim: this study will “test the impact of the enhanced implementation strategy of WISE on implementation and child health outcomes using a Hybrid Type III Cluster Randomized Trial and continuous formative evaluation" (quote) Study period: January 2018 to June 2020 Total number of arms: 2 Description of intervention arms: 1. Enhanced WISE strategy (child + caregiver); 2. Basic WISE strategy (child only) Number of clusters per arm: 6 Average cluster size: not known Sample size justification and outcome used: study authors based power calculations on data from the previous WISE study. For the present study, study authors reported that the design will provide 80% power to detect an effect of 0.40 (a half standard deviation) with a 5% probability of a type 1 error Unit of allocation: Head Start center Missing data handling: not known Reported limitations: not known Randomization ratio and stratification: 1:1; stratified by center size and key zip code characteristics (e.g. food insecurity, poverty) Participant compensation or incentives: not known
Participants	Baseline characteristics: not known Recruitment methods: not known; all centers (n = 12) from the partnering Head Start agency will be randomized to implement the basic WISE strategy or the enhanced WISE strategy Inclusion criteria: clusters: centers within the partnering Head Start agency; participants: child enrolled in a participating center, aged 3 to 5 years Exclusion criteria: not known Age of participating children at baseline: 3 to 5 years Total number randomized by relevant group: 760 children anticipated 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): obesity prevention intervention to improve feeding practices and children’s dietary behaviors in childcare settings Focus of intervention: diet Behavior change techniques: not known Why: rationale, theory, or goal (TIDieR #2): in addition to the child‐only arm, study authors aim to develop and test additional implementation strategies to improve implementation of WISE in childcare settings How, where, and when and how much (TIDieR #6 to 8): not known Who: providers (TIDieR #5): trained educators Economic variables and resources required for replication: not known Strategies to address disadvantage: focus on low‐income children enrolled in Head Start centers Subgroups: not known Assessment time points: not known Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): not known 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 Child‐only arm (control group) Brief name/description (TIDieR #1): obesity prevention intervention to improve feeding practices and children’s dietary behaviors in childcare settings Focus of intervention: diet Behavior change techniques: "shaping knowledge," "comparison of behavior," "repetition and substitution" Why: rationale, theory, or goal (TIDieR #2): study authors report “a paucity of research exploring the use of implementation strategies to support uptake of evidence‐based practices for obesity prevention in childcare in the US.” The WISE intervention was informed by evidence‐based recommendations for nutrition promotion among children and concepts of the socioecological model How, where, and when and how much (TIDieR #6 to 8): children receive 8 monthly nutrition education units over the intervention period. Educators receive an interactive 4‐ to 6‐hour training to facilitate nutrition education sessions. Monthly “back pack” letters are sent home to parents. Parents are also invited to join Facebook groups with other parents and educators and to participate in food‐based activities during monthly parent‐teacher nights Who: providers (TIDieR #5): trained educators Economic variables and resources required for replication: not known Strategies to address disadvantage: focus on low‐income children enrolled in Head Start centers Subgroups: not known Assessment time points: not known Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): the classroom nutrition education curriculum focuses on 8 different foods (e.g. apples, bell peppers, tomatoes). Children learn about the growth of each food and participate in hands‐on food preparation and cooking activities. Additional reading materials and recipes are provided. The interactive training for educators is based on adult learning theories and emphasizes the role of educators and parents in child nutrition. Parent engagement materials help introduce parents to the 8 different foods (newsletters, taste tests, snack demos) and provide an opportunity for parent‐parent and parent‐educator communication 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 were used to measure outcomes relevant to this review twice yearly (time points not specified) Children's dietary intake: caregiver completion of a modified, qualitative food frequency questionnaire to assess consumption of WISE foods and objective measure of skin carotenoids using resonance Raman spectroscopy (RRS) Children’s anthropometry: BMI will be obtained from federal assessments (required for all Head Start children)
Notes	Author's name: Taren Swindle Email: tswindle@uams.edu Country: USA Setting: Head Start centers in Arkansas Types of reports: published protocol; trial registration Comments: used the following reports: (1) Swindle 2017, and (2) trial registration (Clinicaltrials.gov registration number NCT03075085) 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 K01 DK110141‐01

ICC: intracluster correlation coefficient.

RRS: resonance Raman spectroscopy.

SD: standard deviation.

TIDieR: Template for Intervention Description and Replication.

USD: United States dollar.