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Family Navigation for Childhood Obesity

N/A
Recruiting
Led By Geoff Ball, PhD RD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 6-17 years old
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, and 12 months post-baseline
Awards & highlights

Study Summary

This trialwill assess how well Family Navigation helps children and families attend pediatric obesity management appointments, which may lead to better health outcomes.

Who is the study for?
This trial is for children aged 6-17 with severe obesity (BMI ≥97th percentile) who are already in obesity management programs in Calgary and Mississauga. Their caregivers must agree to participate and be able to communicate in English, as the Family Navigation service is provided only in English.Check my eligibility
What is being tested?
The study tests if adding Family Navigation (FN), which includes personalized support like parking passes and text messages, to Usual Care can help reduce dropout rates from pediatric obesity programs. Half of the participants will receive FN + Usual Care for a year; the other half will get just Usual Care.See study design
What are the potential side effects?
Since this trial involves additional support services rather than medical treatments, there are no direct side effects associated with interventions like Family Navigation or Usual Care.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 6 and 17 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, and 12 months post-baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, and 12 months post-baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Perceived acceptability of Family Navigation (Caregiver)
Perceived acceptability of Family Navigation (Child)
Secondary outcome measures
Attrition
Child and caregiver motivation to change lifestyle habits
Child- and caregiver-reported internalized and experienced weight bias
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Family Navigation + Usual CareExperimental Treatment2 Interventions
Participants assigned to this arm will receive the Family Navigation (FN) intervention in addition to standard pediatric obesity management (Usual Care).
Group II: Usual CareActive Control1 Intervention
Participants assigned to this arm will standard pediatric obesity management only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Usual Care
1990
Completed Phase 4
~7700
Family Navigation
2015
N/A
~340

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,069 Total Patients Enrolled
Geoff Ball, PhD RDPrincipal InvestigatorUniversity of Alberta

Media Library

Family Navigation Clinical Trial Eligibility Overview. Trial Name: NCT05403658 — N/A
Childhood Obesity Research Study Groups: Family Navigation + Usual Care, Usual Care
Childhood Obesity Clinical Trial 2023: Family Navigation Highlights & Side Effects. Trial Name: NCT05403658 — N/A
Family Navigation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05403658 — N/A

Frequently Asked Questions

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

What is the aggregate enrollment of this experiment?

"Affirmative. Per the clinicaltrials.gov platform, this medical trial is presently searching for candidates after debuting on October 14th 2022 and being updated as recently as November 1st 2022. The research requires 108 individuals to be recruited from a single site."

Answered by AI

What is the aim of this investigation?

"This trial's primary objective is to gauge the acceptability of Family Navigation intervention in children, across a 3-6- and 12 month post baseline period. Secondary outcomes include unintended consequences of treatment (as assessed by survey), strength of therapy relationships between caregivers and navigators/clinicians (measured via Working Alliance Inventory) as well as health services related data concerning appointment frequency, type, mode, duration and changes collected from medical records or electronic scheduling systems."

Answered by AI

Am I able to register for this trial?

"This research protocol is seeking 108 minors with obesity, aged 6-17. The primary criteria for inclusion are as follows: being between the ages of six and seventeen, having a BMI greater than or equal to the 97th percentile, and obtaining consent from an adult caregiver (e.g., parent/guardian)."

Answered by AI

Is the population eligible for this trial aged 55 and over?

"The age range for participation in this trial is from 6 years old to 17, as outlined by the inclusion criteria."

Answered by AI

Are new patients being accepted for the trial at this time?

"The clinical trial data hosted on the website indicates that this study is actively enrolling participants. The research was first made available to the public on October 14th 2022 and has been updated as of November 1st 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Attrition in Pediatric Obesity Management
2022. "Attrition in Pediatric Obesity Management". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05403658.
~5 spots leftby Jun 2024
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