Obesity
Conditions
Brief summary
Investigators will pilot test the impact of an enhanced implementation strategy on implementation and child health outcomes using continuous formative evaluation. Investigators will test the hypothesis that better fidelity to the implementation strategy (WISE) is positively related to child outcomes (e.g., child fruit and vegetable intake, BMI).
Detailed description
Investigators will determine whether the enhanced strategy is feasible, acceptable, and demonstrates improved implementation, fidelity, and sustainability using a Hybrid Type 3 implementation design. Investigators expect that the effectiveness of WISE on child outcomes will vary by the level of implementation fidelity, and a Hybrid 3 design allows for us to explore this hypothesis).
Interventions
BEHAVIORALWISE (We Inspire Smart Eating)
An enhanced implementation strategy for evidence-based obesity prevention in childcare
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Investigators will use a Type 3 Hybrid Design to test the effectiveness of the enhanced implementation strategy (i.e., facilitation) on uptake while also assessing impacts of the intervention on child outcomes. Investigators expect that the effectiveness of WISE on child outcomes will vary by the level of implementation fidelity, and a Hybrid 3 design allows for us to explore this hypothesis. RE-AIM provides an evaluation framework to assess key aspects of intervention programs implemented in real-word settings. Investigators will modify and use The Organizational Readiness to Change Assessment (ORCA) as developed for use with the i-PARiHS framework to assesses change commitment (e.g., We value this change) and change efficacy (e.g., We can keep the momentum going) both prior to and during implementation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Early childhood educators from our partnering Head Start agency
Exclusion criteria
* Secondary Outcome Inclusion Criteria: * Children aged 3-5 years old in our partnering Head Start agency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices | From Baseline Up to 8 months | 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. |
Countries
United States
Participant flow
Recruitment details
771 individuals were included in all study activities/aims. 488 individuals were included in the study trial.
Participants by arm
| Arm | Count |
|---|---|
| Basic WISE Strategy These participants were asked to implement WISE using a basic implementation strategy (training and reminders only). | 246 |
| 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. | 242 |
| Total | 488 |
Baseline characteristics
| Characteristic | Basic WISE Strategy | Enhanced WISE Strategy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 210 Participants | 203 Participants | 413 Participants |
| Age, Categorical >=65 years | 6 Participants | 8 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 31 Participants | 61 Participants |
| Age, Continuous | 4.1 years STANDARD_DEVIATION 0.6 | 4.1 years STANDARD_DEVIATION 0.6 | 4.1 years STANDARD_DEVIATION 0.6 |
| Carotenoid Intake | 25403.9 resonance raman spectroscopy units STANDARD_DEVIATION 9032.6 | 24732.8 resonance raman spectroscopy units STANDARD_DEVIATION 9041.3 | 25340.6 resonance raman spectroscopy units STANDARD_DEVIATION 9031.98 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 152 Participants | 186 Participants | 338 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 55 Participants | 16 Participants | 71 Participants |
| Race (NIH/OMB) White | 32 Participants | 36 Participants | 68 Participants |
| Region of Enrollment United States | 246 Participants | 242 Participants | 488 Participants |
| Sex: Female, Male Female | 168 Participants | 147 Participants | 315 Participants |
| Sex: Female, Male Male | 78 Participants | 95 Participants | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 352 | 0 / 344 |
| other Total, other adverse events | 0 / 352 | 0 / 344 |
| serious Total, serious adverse events | 0 / 352 | 0 / 344 |
Outcome results
Primary
Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices
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.
Time frame: From Baseline Up to 8 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Basic WISE Strategy | Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices | Role Modeling | 4 Classrooms |
| Basic WISE Strategy | Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices | Use of Mascot | 2 Classrooms |
| Basic WISE Strategy | Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices | Hands On Exposure | 1 Classrooms |
| Enhanced WISE Strategy | Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices | Role Modeling | 10 Classrooms |
| Enhanced WISE Strategy | Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices | Use of Mascot | 4 Classrooms |
| Enhanced WISE Strategy | Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices | Hands On Exposure | 6 Classrooms |