| Methods |
Study design: cluster‐randomized controlled trial
Study grouping: factorial assignment
Study aim: this study "builds on prior research to engage multiple sectors of the community to reduce the risk of childhood obesity by promoting healthful food and activity environments, policies and behaviors through: 1) developing and testing the efficacy of a 4th grade comprehensive school‐ and family‐based intervention, 2) applying this intervention to an afterschool setting, and 3) state‐wide program dissemination" (quote)
Study period: not known
Total number of arms: 4 (note: trial registration indicates 5 arms, including a no intervention control arm)
Description of intervention arms: 1. School‐based intervention plus both family intervention and online parent‐based intervention (child + caregiver A); 2. School‐based intervention plus family intervention (child + caregiver B); 3. School‐based intervention plus online parent‐based intervention (child + caregiver C); 4. School‐based condition (child only)
Number of clusters per arm: not known
Average cluster size: not known
Sample size justification and outcome used: power calculations sought to determine minimum sample sizes to detect a clinically relevant change at a power of 80% and a 5% probability of a type 1 error. Study authors based power calculations on data from prior studies with fourth grade Colorado students and their parents. Instead study authors reported sample sizes needed per group for 7 outcomes: child attitude (n = 50), child self‐efficacy (n = 108), child fruit and vegetable preference (n = 127), parent modeling (n = 64), parent self‐efficacy (n = 110), parent fruit and vegetable availability (n = 15), and parent eating competence (n = 105). They did not report the sample sizes needed to detect a change in the primary outcomes (fruit and vegetable consumption at school lunch and student activity level) nor in the secondary outcome (BMI)
Unit of allocation: school
Missing data handling: not known
Reported limitations: 1. The target audience lacks diversity, therefore potentially limiting the generalizability of results; 2. Caregiver involvement will be indirect; 3. If teachers continue teaching fourth grade in participating schools, they will participate in more than 1 intervention arm, which could influence their involvement; 4. Long‐term follow‐up is not possible
Randomization ratio and stratification: 1:1:1:1; 8 schools were matched on the percentage of students receiving free or reduced‐priced school meals before randomization
Participant compensation or incentives: to motivate participation in the family component, family nights held at schools include a drawing for free cooking and activity prizes. As compensation or participation in accelerometry assessment, children will receive up to USD 25 in gift cards as compensation when they return their device and the device worn by their caregiver. Caregivers will receive e‐gift cards for each dietary recall that they complete and an e‐card and an e‐gift card pin for survey completion |
| Interventions |
Intervention characteristics
Child + caregiver arm A (intervention group)
Brief name/description (TIDieR #1): classroom, cafeteria, and SPARK active recess intervention plus the family intervention and online intervention for parents Focus of intervention: diet and physical activity Behavior change techniques: all behavior change techniques used in child‐only arm and child + caregiver arms B and C Why: rationale, theory, or goal (TIDieR #2): same as child‐only arm How, where, and when and how much (TIDieR #6 to 8): see information reported in child‐only arm and child + caregiver arms B and C Who: providers (TIDieR #5): see providers listed for child‐only arm and child + caregiver arms B and C Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 7 months (end of intervention), 1 year (follow‐up) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): see materials and procedures listed for child‐only arm and child + caregiver arms B and C 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 + caregiver arm B (intervention group)
Brief name/description (TIDieR #1): classroom, cafeteria, and SPARK active recess intervention plus the family intervention Focus of intervention: diet and physical activity Behavior change techniques: in addition to the child‐only intervention, the following techniques were applied separately or differently in this arm: "social support," "shaping knowledge," "repetition and substitution," "reward and threat," "antecedents" 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 intervention, schools assigned to this arm will hold 2 Family Nights per year (fall and spring) at the school, families will receive action packs after each cooking and tasting lesson, and parents will have access to a blog throughout the intervention Who: providers (TIDieR #5): school cafeteria staff will serve a light meal at family nights. Study authors do not report who will deliver other activities specific to this intervention arm. Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 7 months (end of intervention), 1 year (follow‐up) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): Family Nights include crafts, cooking and tasting stations to mimic what students are learning in the classroom, SPARK games, a light meal, and a drawing for cooking and activity prizes. Action packs encourage parents and other family members to participate with the child in SPARK Active Recess games. Family participation is documented with a parent signature, and the child is asked to return the completed action pack by the following lesson. The parent blog is administered through a private Facebook page and provides tips about cooking with children, encouraging children to try new foods, and physical activities for the family. New content is posted weekly and parents are sent reminders to view the posts Tailoring (TIDieR #9): content of the blog is slightly tailored to each school to align with the dates of intervention activities 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 + caregiver arm C (intervention group)
Brief name/description (TIDieR #1): classroom, cafeteria, and SPARK active recess intervention plus the online intervention for parents Focus of intervention: diet and physical activity Behavior change techniques: in addition to the child‐only intervention, the "shaping knowledge" BCT was applied separately or differently in this arm Why: rationale, theory, or goal (TIDieR #2): same as child‐only arm How, where, and when and how much (TIDieR #6 to 8): 6 web‐based lessons that can be viewed in any order and as often as desired following completion of the baseline survey. Study authors note that the caregivers can complete the lessons with "individually tailored depth and scope of participation" Who: providers (TIDieR #5): this is a self‐directed program Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 7 months (end of intervention), 1 year (follow‐up) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): lessons focus on food enjoyment and acceptance, attention to internal regulation, food resource management skills, and physical activity 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): classroom, cafeteria, and SPARK active recess intervention Focus of intervention: diet and physical activity Behavior change techniques: "shaping knowledge," "comparison of behavior," "repetition and substitution," "antecedents" Why: rationale, theory, or goal (TIDieR #2): this intervention builds on prior research and the principles of the Satter eating competence model, social cognitive theory, experiential learning theory, the socioecological model, behavioral economics, and social marketing. Study authors note the importance of addressing the context in which individuals make eating and activity choices, and that for children this includes not only themselves, but their communities, schools, families, and parents How, where, and when and how much (TIDieR #6 to 8): classroom component includes 5 two‐hour cooking lessons and 5 one‐hour tasting lessons taught over the course of 1 academic year (approximately 1 lesson every 3 weeks). Lessons are taught in the classroom or cafeteria. The cafeteria component is delivered during the weeks that cooking and tasting lessons are delivered. The SPARK active recess activities are led at least 4 days per week during the regular 20‐minute daily recess period Who: providers (TIDieR #5): the classroom component is taught by graduate nutrition students trained as food educators, with assistance from another nutrition student and the classroom teacher. Cafeteria staff deliver the cafeteria component. Trained active recess leaders (university health and exercise science students) lead the active recess component Economic variables and resources required for replication: not known Strategies to address disadvantage: not known Subgroups: not known Assessment time points: baseline, 7 months (end of intervention), 1 year (follow‐up) Co‐interventions: not known What: materials and procedures (TIDieR #3 to 4): cooking and tasting lessons ("Cooking with Kids—Colorado") use experiential learning techniques and emphasize practical cooking skills using fresh and affordable foods. FFF Cafeteria Connections includes serving fruit and vegetable items that children have prepared in the classroom on the lunch menu, increasing fruit and vegetable visibility, and providing verbal encouragement to select fruits and vegetables. The SPARK Active REcess Activities include active games and the provision of additional equipment that supports active recess 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
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