Implementation Strategies for Childhood Obesity Prevention

Overseen By Taren M Swindle, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Using WISE

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1850 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on enhancing the implementation of a program designed to encourage healthy eating habits in young children through various support strategies. It tests whether increasing support intensity for educators—such as providing more tailored educational materials and individualized help—leads to better adoption of practices that promote fruit and vegetable consumption among kids. The trial compares two approaches: a High Intensity strategy and a Low Intensity strategy (also known as the Adaptive Implementation Strategy or Low-Intensity Implementation Approach). Teachers in early care and education centers in parts of Arkansas and Louisiana, who have not yet implemented this program, are ideal participants. The trial aims to identify the most effective and cost-efficient way to help teachers encourage healthier eating habits in children ages 3 to 5. As an unphased trial, it offers participants the chance to contribute to innovative strategies that could significantly improve children's health and nutrition.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both high-intensity and low-intensity methods to prevent childhood obesity in early care settings are generally safe. High-intensity methods effectively help childcare services adopt healthier eating practices. Reports have not indicated negative effects from these methods, which focus on providing support and educational materials.

For low-intensity methods, evidence suggests they are well-received and cost-effective in encouraging healthy habits among young children. These methods support childcare providers rather than directly intervening with children, minimizing risks.

Overall, both high and low-intensity approaches aim to help childcare providers promote healthy eating. Studies have not reported any major safety concerns, indicating these methods are safe for use in early care settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these obesity prevention strategies because they explore tailored implementation intensity to improve fidelity to intervention goals. Unlike typical obesity interventions that follow a one-size-fits-all approach, this trial examines both high and low intensity support systems. High intensity support includes individualized facilitation and tailored educational materials, potentially offering more personalized guidance compared to standard methods. This could lead to more effective and sustainable behavior changes in preventing childhood obesity.

What evidence suggests that this trial's implementation strategies could be effective for childhood obesity prevention?

Research shows that more intensive methods can improve healthy eating habits in early childcare settings. In this trial, participants who do not initially respond well to low-intensity methods will receive high-intensity methods, including personalized support and customized materials. These high-intensity methods often prove more effective than less intensive approaches in enhancing children's health. Evidence suggests that increasing support for non-responders can lead to better adoption of healthy eating habits and adherence to the plan. Meanwhile, participants who respond quickly to low-intensity methods will continue with these less intensive approaches, which provide structured guidance and resources. Overall, this trial tests flexible strategies that adjust the level of support based on initial responses to effectively improve children's diets in educational settings. ^{5 6 7 8 9}

Who Is on the Research Team?

Taren M Swindle, Ph.D.

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Having classrooms currently using WISE.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• High Intensity
• Low Intensity

Trial Overview The 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.

How Is the Trial Designed?

Group I: Non-Responders Increasing to High Intensity Experimental Treatment 2 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 Intensity Active Control 1 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 Intensity Active Control 1 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).

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The implementation optimisation intervention aimed at increasing parental enrolment and attendance in the HENRY obesity prevention programme did not show significant effectiveness, with similar enrolment rates (17.8% vs. 18.0%) and attendance rates (17.1% vs. 13.9%) between intervention and control groups.

External factors, such as national service restructuring and funding cuts, severely impacted the delivery of the HENRY programme, resulting in a significant reduction in the number of parents served, which may have influenced the trial outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Bryant, M., Burton, W., Collinson, M., et al.[2021]

The Wellness Champions for Change trial is a comprehensive study involving 1080 students across 30 schools over 2.5 years, aiming to evaluate the effectiveness of Local Wellness Policies on childhood obesity prevention through training and engagement of both teachers and students.

The study will measure key outcomes such as BMI z-scores, diet patterns, and physical activity, using a robust evaluation framework to determine the impact of these interventions and their potential for large-scale implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Wellness Champions for Change," a multi-level intervention to improve school-level implementation of local wellness policies: Study protocol for a cluster randomized trial. Lane, HG., Deitch, R., Wang, Y., et al.[2023]

A new obesity prevention strategy menu has been created to help communities in Wisconsin develop tailored interventions to combat childhood obesity, based on local needs and resources.

This strategy was developed by a multidisciplinary team and aims to engage communities in selecting and implementing effective policy, systems, and environmental changes to reduce obesity rates over the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Strategy Menu for Community-Level Obesity Prevention. Spahr, C., Wells, A., Christens, BD., et al.[2023]

The study developed an online program called Building Healthy Families (BHF) aimed at improving pediatric weight management in rural communities, utilizing a backward design approach to ensure it meets the needs of various stakeholders, including facilitators and families.

The BHF program includes comprehensive training resources, quality assurance measures, and a data tracking portal, with plans for preliminary testing and effectiveness trials to evaluate its impact on implementation and sustainability in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Packaging of a Pediatric Weight Management Intervention and Implementation Blueprint for Rural and Micropolitan Communities: The Nebraska CORD 3.0 Project. Heelan, KA., Abbey, BM., Bartee, RT., et al.[2022]

A 5-year collaborative program to combat childhood obesity successfully enrolled 832 out of 2746 referred children, with 392 completing the program, demonstrating effective community engagement and accessibility.

Participants who completed the program showed significant health improvements, including a reduction in BMI and increased cardiovascular endurance, indicating the program's efficacy in promoting healthier lifestyles among children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implementation and Five-Year Evolution of a Childhood Healthy Weight Program: Making a Health Care-Community Partnership Work. Barlow, SE., Lorenzi, A., Reid, A., et al.[2021]

The RI-CORD 3.0 Project is adapting the JOIN for ME intervention to effectively address pediatric obesity in low-income communities, emphasizing the need for programs that can be widely implemented.

A robust formative evaluation process, guided by established implementation frameworks, is crucial for selecting effective strategies to disseminate evidence-based pediatric weight management interventions.

NCBI (Pubmed)

pubmed.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. Darling, KE., Hayes, JF., Evans, EW., et al.[2022]

Obesity affects about 12.5 million American youth, highlighting the need for effective population-level interventions to promote healthy behaviors in children.

This review summarizes various intervention strategies across different settings (like schools and communities) and provides examples of successful initiatives that can be replicated to help prevent and control childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population-level intervention strategies and examples for obesity prevention in children. Foltz, JL., May, AL., Belay, B., et al.[2022]

The Melbourne InFANT Program, aimed at preventing childhood obesity, was well-received by participants, with 82-93% finding it useful and relevant, highlighting the importance of engaging mothers in such interventions.

Participants appreciated the program's delivery methods, particularly group sessions and practical strategies for reducing mealtime stress, indicating that these elements contributed to the program's perceived effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mothers' perceptions of Melbourne InFANT Program: informing future practice. Lunn, PL., Roberts, S., Spence, A., et al.[2017]

The Together, We Inspire Smart Eating (WISE) curriculum was successfully implemented in 33 classrooms across 7 preschool centers and 2 elementary schools, targeting low-income children aged 3 to 7.

Educators reported high levels of appropriateness, acceptability, and feasibility of the program, while parents also indicated strong adoption and appropriateness, suggesting that WISE is a promising obesity prevention strategy in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Together, We Inspire Smart Eating (WISE): An Examination of Implementation of a WISE Curriculum for Obesity Prevention in Children 3 to 7 Years. Whiteside-Mansell, L., Swindle, T., Selig, JP.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A family-oriented multidisciplinary intervention program aimed at reducing weight gain in young children with obesity did not result in any significant change in BMI standard deviation scores (SDS) after three years, with both intervention and control groups showing a median decrease of 0.19.

The study involved 31 families in the intervention group and 33 in the control group, with initial BMI SDS values indicating that the program did not effectively curtail weight increase, regardless of social or behavioral factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A family-oriented intervention programme to curtail obesity from five years of age had no effect over no intervention. Donkor, HM., Grundt, JH., Júlíusson, PB., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

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Obesity prevention practices in early care and education settings We hypothesize that sites receiving high-intensity strategies will outperform sites continuing the low-intensity strategies on the primary ...

2. cancercontrol.cancer.gov cancercontrol.cancer.gov/sites/default/files/2023-02/FINAL%20-%20GI_1R37CA252113-01A1.pdf

Testing an Adaptive Implementation Strategy to Optimize ... High-intensity facilitation will be individualized ... intensity strategies will be cost-effective for improving implementation and child health outcomes.

3. withpower.com withpower.com/trial/phase-pediatric-obesity-2-2022-a7834

Implementation Strategies for Childhood Obesity Prevention Evaluation of adaptive implementation strategies to improve adoption of WISE EBPs, including comparison of low-intensity and high-intensity strategies.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03075085

Study Details | NCT03075085 | Developing and Testing ... 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 ...

5. researchgate.net researchgate.net/publication/342287562_High_intensity_versus_low_intensity_family-based_childhood_obesity_treatment_programs_Effectiveness_engagement_and_implementation_outcomes_from_a_randomized_controlled_trial_in_medically_underserved_r

Effectiveness, engagement and implementation outcomes ... High intensity versus low intensity family-based childhood obesity treatment ... childhood obesity treatment literature to identify effective ...

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Childhood obesity-an insight into preventive strategies - PMC For patients who do not respond to a brief clinical intervention or for those with severe obesity, higher-intensity approaches are needed in tertiary care ...

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Measuring the intensity of community programs and ... This study describes the creation of three types of indices for understanding how community programs and policies may contribute to prevention of childhood ...

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Interventions to prevent obesity in school-aged children 6 ... This updated synthesis of obesity prevention interventions for children aged 6–18 years, found a small beneficial impact on child BMI for school ...

9. mdpi.com mdpi.com/1660-4601/17/13/4664

A Three-Arm Randomised Controlled Trial of High High-intensity implementation strategies may be effective in supporting childcare service implementation of individual food group recommendations. Further ...