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| ID | Type | Description | Link |
|---|---|---|---|
| K01DK110141-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basic WISE strategy | Active Comparator | These participants will be asked to implement the basic WISE strategy used in previous studies. |
|
| Enhanced WISE strategy | Experimental | These participants will be asked to implement the enhanced WISE strategy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WISE (We Inspire Smart Eating) | Behavioral | An enhanced implementation strategy for evidence-based obesity prevention in childcare |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline Up to 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taren M Swindle, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22310560 | Background | Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. | |
| 22087679 | Background | Juonala M, Magnussen CG, Berenson GS, Venn A, Burns TL, Sabin MA, Srinivasan SR, Daniels SR, Davis PH, Chen W, Sun C, Cheung M, Viikari JS, Dwyer T, Raitakari OT. Childhood adiposity, adult adiposity, and cardiovascular risk factors. N Engl J Med. 2011 Nov 17;365(20):1876-85. doi: 10.1056/NEJMoa1010112. |
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771 individuals were included in all study activities/aims. 488 individuals were included in the study trial.
| ID | Title | Description |
|---|---|---|
| FG000 | Basic WISE Strategy | These participants were asked to implement WISE using a basic implementation strategy (training and reminders only) |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
At baseline, the Basic WISE strategy included 210 children and 36 teachers. At baseline, the Enhanced WISE strategy included 203 children and 39 teachers.
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| ID | Title | Description |
|---|---|---|
| BG000 | Basic WISE Strategy | These participants were asked to implement WISE using a basic implementation strategy (training and reminders only). |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Units | Classrooms | From Baseline Up to 8 months | Classrooms | Classrooms |
|
Through study completion, an average of 9 months from enrollment
Through study completion, an average of 9 months from enrollment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Basic WISE Strategy | These participants were asked to implement WISE using a basic implementation strategy (training and reminders only). |
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The turnover documented in this study (43% of teacher positions overall) is notably higher than national estimates for Head Start turnover (17-20%). Further, the uncertainty of the program's funding and the news of coming layoffs and site/classroom moves near the end of the trial were disruptive. The research team adapted to these changes in delivery of implementation strategies (e.g., facilitation to new educators) and data interpretation (i.e., focus on univariate analyses).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Taren Swindle | University of Arkansas for Medical Sciences | 870-236-0997 | tswindle@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2019 | Jun 16, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C480733 | SOSTDC1 protein, human |
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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.
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| 33933130 | Derived | Swindle T, McBride NM, Selig JP, Johnson SL, Whiteside-Mansell L, Martin J, Staley A, Curran GM. Stakeholder selected strategies for obesity prevention in childcare: results from a small-scale cluster randomized hybrid type III trial. Implement Sci. 2021 May 1;16(1):48. doi: 10.1186/s13012-021-01119-x. |
| 30181874 | Derived | Swindle T, Selig JP, Rutledge JM, Whiteside-Mansell L, Curran G. Fidelity monitoring in complex interventions: a case study of the WISE intervention. Arch Public Health. 2018 Aug 29;76:53. doi: 10.1186/s13690-018-0292-2. eCollection 2018. |
| 28720140 | Derived | Swindle T, Johnson SL, Whiteside-Mansell L, Curran GM. A mixed methods protocol for developing and testing implementation strategies for evidence-based obesity prevention in childcare: a cluster randomized hybrid type III trial. Implement Sci. 2017 Jul 18;12(1):90. doi: 10.1186/s13012-017-0624-6. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | This refers to the age of the child. Age of teacher was collected categorically without measures of dispersion. | This refers to age of the child. Age of teacher was collected categorically. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Carotenoid Intake | This is a baseline measure for children in the study only, not teachers | This is a baseline measure for the children in the study only. | Mean | Standard Deviation | resonance raman spectroscopy units |
|
| OG000 |
| Basic WISE Strategy |
These classrooms were asked to implement WISE using a basic implementation strategy (training and reminders only). |
| OG001 | Enhanced WISE Strategy | 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. |
|
|
| 0 |
| 352 |
| 0 |
| 352 |
| 0 |
| 352 |
| EG001 | 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. | 0 | 344 | 0 | 344 | 0 | 344 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|