1850 Participants Needed

Implementation Strategies for Childhood Obesity Prevention

TM
Overseen ByTaren M Swindle, Ph.D.
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of Arkansas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

"Together, We Inspire Smart Eating" (WISE) is an intervention that improves children's diets in ECE. WISE includes 4 key evidence-based practices (EBPs): (1) hands-on exposures to fruits and vegetables, (2) role modeling by educators, (3) positive feeding practices, and (4) a mascot associated with fruits and vegetables. Standard implementation approaches to WISE result in suboptimal implementation of WISE EBPs. Additional implementation strategies are needed to increase adoption and fidelity to EBPs. To date, most studies have employed an "all-or-nothing" approach, comparing multifaceted strategies to control groups without implementation support. Thus, there is an urgent need for optimized strategies that tailor implementation support intensity to the unique challenges and limited resources of the ECE context. The overall objectives of this application are to determine the effectiveness and cost-effectiveness of an adaptive implementation approach to improve adoption of the EBPs of WISE while also examining implementation mechanisms. The central hypothesis is that the addition of high-intensity strategies at sites that do not respond to low-intensity strategies will improve implementation and health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment High Intensity, Low Intensity, Adaptive Implementation Strategy, Low-Intensity Implementation Approach for childhood obesity prevention?

Research shows that multidisciplinary treatments, like the Healthy Weight Clinic, can effectively improve BMI (a measure of body fat) in children with obesity. This suggests that structured, comprehensive approaches may be beneficial in managing childhood obesity.12345

Is the implementation strategy for childhood obesity prevention safe for humans?

The studies reviewed focus on the implementation and effectiveness of obesity prevention programs in schools and childcare settings, but they do not report any safety concerns or adverse effects related to these programs. This suggests that the strategies are generally considered safe for use in humans.36789

How does the treatment in the Implementation Strategies for Childhood Obesity Prevention trial differ from other treatments for childhood obesity?

This treatment is unique because it focuses on implementing community-level strategies and engaging multiple settings like schools, homes, and healthcare to promote healthy behaviors in children, rather than relying solely on individual or clinical interventions. It emphasizes collaboration between healthcare and community organizations to create sustainable, tailored interventions based on local needs.510111213

Research Team

TM

Taren M Swindle, Ph.D.

Principal Investigator

University of Arkansas

Eligibility Criteria

This trial is for early care and education settings not currently using the WISE program, serving at least 15 children aged 3 to 5. They must be in certain regions of Arkansas or Louisiana, participate in specific food programs, and agree to join in activities and data collection.

Inclusion Criteria

Participation in Child and Adult Care Food Program in the states' quality rating system
Recruited teachers at participating early care and education site in Arkansas River Valley
Having no classrooms currently using WISE.
See 5 more

Exclusion Criteria

Having classrooms currently using WISE.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation Strategy Evaluation

Evaluation of adaptive implementation strategies to improve adoption of WISE EBPs, including comparison of low-intensity and high-intensity strategies.

Approximately 2 years
Regular assessments and strategy adjustments

Follow-up

Participants are monitored for fidelity to WISE EBPs and child health outcomes after implementation strategies are applied.

4-6 months

Treatment Details

Interventions

  • High Intensity
  • Low Intensity
Trial OverviewThe study tests 'Together, We Inspire Smart Eating' (WISE), aiming to improve kids' diets through hands-on experiences with fruits/veggies, educator role modeling, positive feeding practices, and a mascot. It compares low vs high-intensity strategies for better adoption.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Non-Responders Increasing to High IntensityExperimental Treatment2 Interventions
This group will include those not achieving desired levels of fidelity by the October assessment who will be randomized to have high intensity support added (low intensity + holistic individualized facilitation, tailored educational materials).
Group II: Non-Responders Continue Low IntensityActive Control1 Intervention
This group will include those not achieving desired levels of fidelity by the October assessment who will be randomized to continue receiving low intensity implementation support (i.e., formal commitments, local champions, implementation blueprint, reminder cutting boards, task-focused implementation).
Group III: Early Responders to Low IntensityActive Control1 Intervention
Early responders will include those with targeted levels of fidelity by the October assessment. They will continue to receive low intensity implementation support (i.e., formal commitments, local champions, implementation blueprint, reminder cutting boards, task-focused implementation).

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials
500
Recruited
153,000+

Louisiana Tech University

Collaborator

Trials
1
Recruited
1,900+

Findings from Research

A systematic process was used to adapt an evidence-based intervention for adolescent weight management into a group-based telehealth format, addressing the obesity epidemic effectively in clinical settings.
The adaptation involved collaboration between clinicians and researchers, utilizing the RE-AIM framework to ensure the intervention was suitable for real-world delivery, which included broader inclusion criteria and practical fidelity checklists for consistent implementation.
Translation of a family-based behavioral intervention for adolescent obesity using the RE-AIM framework and common steps from adaptation frameworks.Biggs, BK., Rodgers, KV., Nayman, SJ., et al.[2023]
The Healthy Weight Clinic (HWC) is a multidisciplinary approach designed to improve BMI in children with obesity, and its implementation will be evaluated using established frameworks to ensure effectiveness and sustainability.
The study will assess various factors such as adoption, acceptability, and feasibility of the HWC in primary care, utilizing qualitative interviews and surveys to gather data on patient outcomes and program success.
Planned Evaluation of the Healthy Weight Clinic Pediatric Weight Management and Implementation: Massachusetts-CORD 3.0.Fiechtner, L., Sierra Velez, D., Ayala, SG., et al.[2023]
This study will evaluate the effectiveness of enhanced implementation strategies for obesity prevention practices in childcare settings, involving 12 Head Start centers and approximately 400 children, using a randomized trial design.
The research aims to identify barriers and facilitators to adopting evidence-based practices, ultimately improving the reach and effectiveness of obesity prevention interventions in childcare through a stakeholder-driven approach.
A mixed methods protocol for developing and testing implementation strategies for evidence-based obesity prevention in childcare: a cluster randomized hybrid type III trial.Swindle, T., Johnson, SL., Whiteside-Mansell, L., et al.[2019]

References

Translation of a family-based behavioral intervention for adolescent obesity using the RE-AIM framework and common steps from adaptation frameworks. [2023]
Planned Evaluation of the Healthy Weight Clinic Pediatric Weight Management and Implementation: Massachusetts-CORD 3.0. [2023]
A mixed methods protocol for developing and testing implementation strategies for evidence-based obesity prevention in childcare: a cluster randomized hybrid type III trial. [2019]
A family-oriented intervention programme to curtail obesity from five years of age had no effect over no intervention. [2021]
A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial. [2021]
"Wellness Champions for Change," a multi-level intervention to improve school-level implementation of local wellness policies: Study protocol for a cluster randomized trial. [2023]
Packaging of a Pediatric Weight Management Intervention and Implementation Blueprint for Rural and Micropolitan Communities: The Nebraska CORD 3.0 Project. [2022]
Mothers' perceptions of Melbourne InFANT Program: informing future practice. [2017]
Together, We Inspire Smart Eating (WISE): An Examination of Implementation of a WISE Curriculum for Obesity Prevention in Children 3 to 7 Years. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
The Implementation and Five-Year Evolution of a Childhood Healthy Weight Program: Making a Health Care-Community Partnership Work. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Implementation of the JOIN for ME Program for Families from Low-Income Backgrounds: The Use of Theory-Driven Formative Evaluation: Rhode Island CORD 3.0. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Population-level intervention strategies and examples for obesity prevention in children. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Developing a Strategy Menu for Community-Level Obesity Prevention. [2023]