Fit Together Program for Childhood Obesity

Recruiting at 1 trial location

Overseen By Valery R Arevalo

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Injuries, Disabilities, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 months

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The proposed project will test an implementation strategy (the "TrailGuide") for delivering an existing model of pediatric obesity treatment ("Fit Together") that has demonstrated ability to meet published recommendations for improving health outcomes of children with obesity.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What safety data is available for the Fit Together Program for childhood obesity?

The Fit Together Program, also known as Parks & Pediatrics Fit Together, has been evaluated in various studies. It integrates healthcare and community resources to provide lifestyle modification, meeting recommended treatment guidelines. The program has been shown to be effective in reducing body mass index (BMI) and improving cardiovascular risk factors in children. Safety data is implied through its structured approach and successful outcomes in reducing obesity-related health risks, as documented in studies involving similar programs like Fit2Play™ and Parks Rx 4Health™. ^{1 2 3 4 5}

Is the Fit Together treatment a promising way to help with childhood obesity?

Yes, the Fit Together treatment is promising for childhood obesity. It combines healthcare and community resources to provide effective lifestyle changes, like physical activity and healthy eating, which are important for managing weight. This program is especially helpful for communities that might not have easy access to such resources. ^{1 2 3 6 7}

What data supports the idea that Fit Together Program for Childhood Obesity is an effective treatment?

The available research shows that the Fit Together Program is effective because it meets the recommended 26 hours of lifestyle changes over 6-12 months by combining healthcare and community resources. Pediatric providers help with obesity screening and counseling, while Parks and Recreation offers spaces for nutrition and physical activity programs. This approach ensures that children receive comprehensive support, making it a successful treatment model for childhood obesity. ^{1 8 9 10 11}

Are You a Good Fit for This Trial?

This trial is for children aged 6-11 with obesity, defined as having a BMI at or above the 95th percentile. They must be English or Spanish speakers receiving care at participating clinics. A caregiver with a smartphone willing to download study apps and who spends significant time with the child is also required. Families planning to move away within the next year are excluded.

Inclusion Criteria

Child receives primary care at one of the participating clinics

My BMI is in the top 5% for my age and sex.

My child is between 6 and 11 years old.

Exclusion Criteria

I have injuries or disabilities that stop me from being physically active.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care obesity treatment and participate in the Fit Together program for 12 months

12 months

Regular visits throughout the 12-month period

Follow-up

Participants are monitored for changes in BMI, physical activity, quality of life, and other health metrics

6 months

Implementation Evaluation

Evaluation of program implementation fidelity and characteristics

30 months

What Are the Treatments Tested in This Trial?

Interventions

• Educational materials
• Fit Together

Trial Overview The 'Parks & Pediatrics Fit Together' trial tests an implementation strategy called 'TrailGuide' for delivering 'Fit Together', a pediatric obesity treatment program known to improve health outcomes in obese children by using educational materials.

How Is the Trial Designed?

Group I: Fit Together Experimental Treatment 1 Intervention

Participants in the intervention arm will receive standard of care obesity treatment from their provider and be able to participate in the Fit Together program and attend activity sessions throughout the duration of their 12 month participation.

Group II: Control Active Control 1 Intervention

Participants in the control arm will receive standard of care obesity treatment from their provider and a healthy cooking magazine mailed to them at a regular interval throughout the duration of their 12 month participation

Fit Together is already approved in United States for the following indications:

Approved in United States as Fit Together for:

• Pediatric obesity

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

The Fit Together model integrates healthcare and community resources to provide effective treatment for childhood obesity, aiming for at least 26 hours of lifestyle modification over 6-12 months, particularly benefiting racial and ethnic minorities and low-wealth populations.

The study will evaluate the effectiveness of an online implementation platform (the Playbook) in delivering Fit Together to 400 children aged 6-11 with obesity, measuring changes in body mass index and physical activity over 6 and 12 months compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating knowledge into action for child obesity treatment in partnership with Parks and Recreation: study protocol for a hybrid type II trial. Neshteruk, CD., Skinner, AC., Counts, J., et al.[2023]

The FITOC program successfully treated obese children aged 8-11, leading to significant improvements in weight management, physical fitness, and cardiac risk profiles over an 8-month intervention and sustained results after 2.5 years.

The program can be effectively transferred to other regions in Germany, demonstrating that with proper training and comparable conditions, similar positive outcomes can be achieved in treating childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Freiburg intervention program for ambulatory therapy of obesity in childhood (FITOC)]. Korsten-Reck, U., Rudloff, C., Kayser, R., et al.[2019]

A two-week weight-management camp followed by a 10-week community intervention significantly reduced BMI in overweight and obese Qatari children (n=300), demonstrating effective weight management strategies.

The combination of cognitive behavioral therapy and behavior change techniques in the community program helped maintain weight loss achieved during the camp, indicating its potential for long-term weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing a multicomponent lifestyle intervention for combatting childhood obesity. Vlaev, I., Taylor, MJ., Taylor, D., et al.[2021]

A survey of 18 pediatric obesity-management programs revealed that most are adhering to the 2007 Expert Committee assessment recommendations, indicating a commitment to standardized care.

However, the study highlighted significant variability in the assessment tools and protocols used across different programs, which poses challenges for standardizing methodologies and establishing a national registry for pediatric obesity clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of obese children and adolescents: a survey of pediatric obesity-management programs. Eisenmann, JC.[2022]

In a study of 394 obese youth aged 5 to 19, participation in a family-centered outpatient weight management program led to significant reductions in weight, BMI, and BMI z score over an average of 5.6 months, without hindering growth.

Improvements in metabolic health were also observed, with many participants achieving normal blood pressure, cholesterol, and insulin levels by the end of treatment, indicating that even modest weight loss can lead to substantial health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship of health outcomes to improvement in BMI in children and adolescents. Kirk, S., Zeller, M., Claytor, R., et al.[2013]

The Parks Rx 4Health(TM) program in Miami-Dade County connects pediatricians with community-based health initiatives, allowing doctors to refer overweight and obese children to an evidence-based afterschool program focused on physical activity and nutrition.

This program collects measurable outcomes like body mass index and fitness levels at baseline and after 3 and 6 months, providing valuable data to track patient progress and support ongoing healthcare efforts against childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing childhood obesity through coordinated care: Development of a park prescription program. Messiah, SE., Jiang, S., Kardys, J., et al.[2020]

Participation in the Fit2Play™ afterschool program led to significant reductions in body mass index (BMI) percentiles for overweight and obese children, indicating effective weight management over one school year with 1546 participants.

The program also improved cardiovascular health, as evidenced by significant decreases in systolic and diastolic blood pressure, along with enhanced fitness levels and nutrition knowledge among all participants, highlighting its potential as a valuable intervention for childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a park-based afterschool program replicated over five years on modifiable cardiovascular disease risk factors. Messiah, SE., Vidot, D., Hansen, E., et al.[2022]

The Let's Go! 5-2-1-0 pediatric obesity intervention program was implemented in a pilot study involving 8 classrooms of second- and third-grade children, but it did not lead to significant improvements in healthy habits, BMI, or physical activity compared to a control group.

The study highlighted the feasibility of the intervention, but the lack of significant results may be attributed to the small sample size and potential external factors influencing children's habits, suggesting that future research should involve larger groups and more comprehensive assessment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elementary School-Based Obesity Intervention Using an Educational Curriculum. Lynch, BA., Gentile, N., Maxson, J., et al.[2022]

In a study of 3090 overweight and obese children participating in the Go4Fun program, attending at least five sessions led to significant improvements in BMI z-score, fruit and vegetable intake, and physical activity levels.

Children whose mothers had lower educational qualifications showed less improvement in BMI and vegetable intake, but those attending seven or more sessions had better outcomes, highlighting the importance of both session attendance and maternal education in obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose response relationship between program attendance and children's outcomes in a community based weight management program for children and their families. Khanal, S., Choi, L., Innes-Hughes, C., et al.[2020]

FitKids360 is an effective, low-cost weight management program for overweight and obese youth aged 5-16, showing significant improvements in physical activity, screen time, and dietary behaviors after a 7-week intervention with 258 participants.

Participants increased their moderate to vigorous physical activity by 14 minutes, reduced screen time by 44 minutes, and improved their Family Nutrition and Physical Activity scores, with many moving out of the 'high risk' category for obesity-related factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FitKids360: design, conduct, and outcomes of a stage 2 pediatric obesity program. Tucker, JM., Eisenmann, JC., Howard, K., et al.[2021]

Project FIT is a comprehensive initiative in Grand Rapids, MI, aimed at reducing childhood obesity through collaboration among schools, health systems, and community organizations, focusing on promoting physical activity and healthy eating.

Baseline data from 403 low-income children showed alarming health trends, with 70% not meeting physical activity recommendations and 48.5% being overweight or obese, highlighting the urgent need for interventions like Project FIT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project FIT: rationale, design and baseline characteristics of a school- and community-based intervention to address physical activity and healthy eating among low-income elementary school children. Eisenmann, JC., Alaimo, K., Pfeiffer, K., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Translating knowledge into action for child obesity treatment in partnership with Parks and Recreation: study protocol for a hybrid type II trial. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

[Freiburg intervention program for ambulatory therapy of obesity in childhood (FITOC)]. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Testing a multicomponent lifestyle intervention for combatting childhood obesity. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Assessment of obese children and adolescents: a survey of pediatric obesity-management programs. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The relationship of health outcomes to improvement in BMI in children and adolescents. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Reducing childhood obesity through coordinated care: Development of a park prescription program. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Impact of a park-based afterschool program replicated over five years on modifiable cardiovascular disease risk factors. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Elementary School-Based Obesity Intervention Using an Educational Curriculum. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Dose response relationship between program attendance and children's outcomes in a community based weight management program for children and their families. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

FitKids360: design, conduct, and outcomes of a stage 2 pediatric obesity program. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Project FIT: rationale, design and baseline characteristics of a school- and community-based intervention to address physical activity and healthy eating among low-income elementary school children. [2022]