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?

This trial explores a new approach called "Fit Together" to help children with obesity become healthier. It tests the program's effectiveness compared to standard care by involving children in enjoyable activities and sessions over several months. The trial includes different groups: a control group receiving standard care and two experimental groups receiving additional support through the Fit Together program. Suitable candidates are children aged 5-12 who are significantly above the normal weight range for their age and receive care at specific clinics. Participants should be able to engage in physical activities and speak English or Spanish. As an unphased trial, this study offers a unique opportunity for children to benefit from innovative support while contributing to valuable research.

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 prior data suggests that the Fit Together program is safe for children with obesity?

Research shows that the "Fit Together" program safely treats childhood obesity. Studies have found it effectively lowers body mass index (BMI) and improves heart health in children. Importantly, these studies have reported no major safety issues.

For the "Fit Together - BCF Cohort," research suggests the program not only aids in weight management but also increases physical activity and improves quality of life. Again, the research has noted no major safety concerns.

Both programs combine clinic visits and community support to assist children. This approach appears well-received, with no serious side effects reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Fit Together Program because it offers a fresh approach to tackling childhood obesity by integrating social and physical activities with standard care. Unlike traditional treatments that focus solely on dietary changes and exercise recommendations, Fit Together includes engaging activity sessions that aim to make healthy living fun and sustainable for kids. Additionally, the Fit Together - BCF Cohort provides access to the Bull City Fit program, which offers a community-oriented space for children to get active and learn about healthy habits in a supportive environment. These unique elements could potentially lead to more effective long-term lifestyle changes compared to standard care alone.

What evidence suggests that the Fit Together program is effective for childhood obesity?

Research has shown that the Fit Together program, an intervention in this trial, may help lower body mass index (BMI) and improve heart health in children with obesity. The program partners clinics with community groups, a strategy that has succeeded in various settings. Early studies suggest this model helps children manage their weight and enhance their overall health. Specifically, participants in the Fit Together - BCF Cohort, another arm of this trial, demonstrated similar improvements in BMI and heart health. This approach employs various strategies to encourage healthier lifestyle choices in children. Overall, evidence suggests that Fit Together could be a valuable option for addressing childhood obesity. ^{1 2 3 4 5}

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 - BCF Cohort Experimental Treatment 1 Intervention

Participants in the Fit Together - BCF Cohort arm will receive standard of care obesity treatment at the Duke Healthy Lifestyles clinic and attend Bull City Fit throughout the duration of their 6 month participation

Group II: 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 III: 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

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]

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]

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 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 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]

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]

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]

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]

Citations

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clinicaltrials.gov

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NCT05455190 | Parks & Pediatrics Fit Together

Fit Together intervention follows a clinic and community partnership model for childhood obesity treatment. Children with obesity will receive standard of care ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9951422/

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Research studies have demonstrated that the Fit Together model is feasible to deliver in diverse community settings, acceptable to patients and ...

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Fit Together

“This is a hybrid study to evaluate implementation as well as patient-level outcomes of the clinic-community partnership model for pediatric obesity ...

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trialx.com/clinical-trials/listings/274200/parks-pediatrics-fit-together/?&geo_lat=36.1024&geo_lng=-80.2228&radius=10&place=Winston%20Salem&user_country=United%20States

Parks & Pediatrics Fit Together | Clinical Research Trial ...

The proposed project will test an implementation strategy (the "TrailGuide") for delivering an existing model of pediatric obesity treatment (" ...

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pediatrics.duke.edu

pediatrics.duke.edu/research/institutes-centers-and-programs/duke-center-childhood-obesity-research-dccor/current-research

Current Research | Duke Department of Pediatrics

This is a hybrid study to evaluate implementation as well as patient-level outcomes of the clinic-community partnership model for pediatric obesity treatment ...