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Behavioral Intervention

Fit Together Program for Childhood Obesity

N/A

Recruiting

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months, 12 months

Awards & highlights

Study Summary

This trialwill test a way to provide an existing treatment for childhood obesity, with the goal of improving health outcomes.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves educational materials and lifestyle changes rather than medication, traditional side effects are not applicable. However, participants may experience changes in behavior or physical activity levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in number of combined minutes per day of moderate and vigorous physical activity, as measured by Garmin vivofit4 fitness tracker

Change in percent of the 95th percentile for BMI Collected from clinic records.

Proportion of children with 26 hours or more of intervention contact

Secondary outcome measures

Change in diet quality

Change in quality of life

Change in self-report physical activity

+5 more

Other outcome measures

Assessment of harms related to the program

Change in blood pressure

Change in mental health

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Fit TogetherExperimental Treatment1 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: ControlActive Control1 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,362 Previous Clinical Trials

3,419,821 Total Patients Enrolled

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

1,964 Previous Clinical Trials

2,674,330 Total Patients Enrolled

Media Library

Fit Together (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05455190 — N/A

Childhood Obesity Research Study Groups: Fit Together, Control

Childhood Obesity Clinical Trial 2023: Fit Together Highlights & Side Effects. Trial Name: NCT05455190 — N/A

Fit Together (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05455190 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for participation in this trial restricted to individuals under 45 years old?

"As outlined in the trial's prerequisites, any individual between 6 and 11 years of age is eligible to enrol."

Answered by AI

Is this investigation still open to new participants?

"As indicated by clinicaltrials.gov, this medical experiment is in progress and open for recruitment. The research was first made available on November 17th 2022 and last edited December 27th 2022."

Answered by AI

Who has the criteria to partake in this medical experiment?

"To qualify for this clinical research project, candidates must display signs of pediatric obesity and be within the 6-11 age bracket. At present, 400 potential participants are being actively recruited."

Answered by AI

How many participants have enrolled in this trial thus far?

"Affirmative. The information on clinicaltrials.gov exhibits that this research is still recruiting volunteers. This investigation was first published on November 17th 2022 and its most recent update occurred December 27th of the same year. At present, 400 individuals are needed between 2 sites for enrolment into the study."

Answered by AI

What results are researchers expecting to find from this clinical investigation?

"This prospective clinical trial will evaluate the efficacy of a treatment by assessing its ability to improve subjects' physical activity, diet quality and health-related quality of life over Baseline, 6 months and 12 months. Additionally, this study also seeks to identify any possible adverse events associated with the intervention."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Parks & Pediatrics Fit Together

2022. "Parks & Pediatrics Fit Together". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05455190.