Trial Outcomes & Findings for Developing and Testing Implementation Strategies for Evidence-Based Obesity Prevention in Childcare (NCT NCT03075085)
NCT ID: NCT03075085
Last Updated: 2021-09-05
Results Overview
The WISE fidelity measure will be used across the school year. The WISE fidelity instrument is rated on a 1 to 4 scale with 4 representing the highest level of fidelity. Each core component is assessed with 2 items. Average fidelity scores above 3 are considered to reflect adequate fidelity on a component. That is, the 2 items on each fidelity component were averaged; an average of above 3 was considered as having achieved fidelity. We are reporting on the total number of classrooms that achieved fidelity in each condition at the spring (final assessment) for the evidence-based practices of WISE.
COMPLETED
NA
696 participants
From Baseline Up to 8 months
2021-09-05
Participant Flow
771 individuals were included in all study activities/aims. 488 individuals were included in the study trial.
Unit of analysis: Childcare centers
Participant milestones
| Measure |
Basic WISE Strategy
These participants were asked to implement WISE using a basic implementation strategy (training and reminders only)
|
Enhanced WISE Strategy
These participants were asked to implement WISE and supported with an Enhanced multi-faceted implementation strategy including a leadership commitment, an implementation blueprint, a local champion, an environmental reminder of the EBPs, facilitation, and tailored educational resources and incentives.
|
|---|---|---|
|
Overall Study
STARTED
|
352 5
|
344 4
|
|
Overall Study
COMPLETED
|
247 5
|
232 4
|
|
Overall Study
NOT COMPLETED
|
105 0
|
112 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This refers to age of the child. Age of teacher was collected categorically.
Baseline characteristics by cohort
| Measure |
Basic WISE Strategy
n=246 Participants
These participants were asked to implement WISE using a basic implementation strategy (training and reminders only).
|
Enhanced WISE Strategy
n=242 Participants
These participants were asked to implement WISE and supported with an Enhanced multi-faceted implementation strategy including a leadership commitment, an implementation blueprint, a local champion, an environmental reminder of the EBPs, facilitation, and tailored educational resources and incentives.
|
Total
n=488 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
210 Participants
n=246 Participants
|
203 Participants
n=242 Participants
|
413 Participants
n=488 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=246 Participants
|
31 Participants
n=242 Participants
|
61 Participants
n=488 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=246 Participants
|
8 Participants
n=242 Participants
|
14 Participants
n=488 Participants
|
|
Age, Continuous
|
4.1 years
STANDARD_DEVIATION 0.6 • n=210 Participants • This refers to age of the child. Age of teacher was collected categorically.
|
4.1 years
STANDARD_DEVIATION 0.6 • n=203 Participants • This refers to age of the child. Age of teacher was collected categorically.
|
4.1 years
STANDARD_DEVIATION 0.6 • n=413 Participants • This refers to age of the child. Age of teacher was collected categorically.
|
|
Sex: Female, Male
Female
|
168 Participants
n=246 Participants
|
147 Participants
n=242 Participants
|
315 Participants
n=488 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=246 Participants
|
95 Participants
n=242 Participants
|
173 Participants
n=488 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=246 Participants
|
0 Participants
n=242 Participants
|
0 Participants
n=488 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=246 Participants
|
0 Participants
n=242 Participants
|
2 Participants
n=488 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=246 Participants
|
0 Participants
n=242 Participants
|
0 Participants
n=488 Participants
|
|
Race (NIH/OMB)
Black or African American
|
152 Participants
n=246 Participants
|
186 Participants
n=242 Participants
|
338 Participants
n=488 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=246 Participants
|
36 Participants
n=242 Participants
|
68 Participants
n=488 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=246 Participants
|
4 Participants
n=242 Participants
|
9 Participants
n=488 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
55 Participants
n=246 Participants
|
16 Participants
n=242 Participants
|
71 Participants
n=488 Participants
|
|
Region of Enrollment
United States
|
246 Participants
n=246 Participants
|
242 Participants
n=242 Participants
|
488 Participants
n=488 Participants
|
|
Carotenoid Intake
|
25403.9 resonance raman spectroscopy units
STANDARD_DEVIATION 9032.6 • n=210 Participants • This is a baseline measure for the children in the study only.
|
24732.8 resonance raman spectroscopy units
STANDARD_DEVIATION 9041.3 • n=203 Participants • This is a baseline measure for the children in the study only.
|
25340.6 resonance raman spectroscopy units
STANDARD_DEVIATION 9031.98 • n=413 Participants • This is a baseline measure for the children in the study only.
|
PRIMARY outcome
Timeframe: From Baseline Up to 8 monthsPopulation: This measure is at the classroom level. Since there are 2 teachers per classroom, the number of classrooms is 18 and 19, respectively. That is, only one teachers per classroom provided data on this outcome. There are multiple classrooms per site, ranging from 1 to 6.
The WISE fidelity measure will be used across the school year. The WISE fidelity instrument is rated on a 1 to 4 scale with 4 representing the highest level of fidelity. Each core component is assessed with 2 items. Average fidelity scores above 3 are considered to reflect adequate fidelity on a component. That is, the 2 items on each fidelity component were averaged; an average of above 3 was considered as having achieved fidelity. We are reporting on the total number of classrooms that achieved fidelity in each condition at the spring (final assessment) for the evidence-based practices of WISE.
Outcome measures
| Measure |
Basic WISE Strategy
n=18 Classrooms
These classrooms were asked to implement WISE using a basic implementation strategy (training and reminders only).
|
Enhanced WISE Strategy
n=19 Classrooms
These classrooms were asked to implement WISE and supported with an Enhanced multi-faceted implementation strategy including a leadership commitment, an implementation blueprint, a local champion, an environmental reminder of the EBPs, facilitation, and tailored educational resources and incentives.
|
|---|---|---|
|
Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices
Role Modeling
|
4 Classrooms
|
10 Classrooms
|
|
Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices
Use of Mascot
|
2 Classrooms
|
4 Classrooms
|
|
Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices
Hands On Exposure
|
1 Classrooms
|
6 Classrooms
|
Adverse Events
Basic WISE Strategy
Enhanced WISE Strategy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Taren Swindle
University of Arkansas for Medical Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place