Family Navigation for Childhood Obesity

Overseen By Marcus O'Neill, MSc RD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Non-English speaking caregivers

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

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Family Navigation (FN) helps children adhere to obesity treatment. Family Navigation provides a trained guide to assist families in overcoming barriers to care, such as offering parking passes and sending supportive texts. Participants must be 6-17 years old, have a BMI at or above the 97th percentile, and have a primary caregiver willing to participate. Half of the participants will receive this additional support along with usual care, while the other half will receive standard care alone. The goal is to assess whether Family Navigation reduces treatment dropout rates. As an unphased trial, this study offers families a unique opportunity to access personalized support that could enhance their child's treatment experience.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on providing additional support rather than changing existing treatments.

What prior data suggests that Family Navigation is safe for children in obesity management?

Research shows that Family Navigation can improve families' access to healthcare and increase their satisfaction with the care received. This may lead to better outcomes in managing childhood obesity. In past studies, teenagers and their caregivers reported that navigators made healthcare access easier. This suggests that families generally find Family Navigation helpful. No reports of negative side effects or safety concerns have emerged with Family Navigation. It is important to understand that this approach focuses on providing support and resources, not medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Navigation approach for childhood obesity because it offers a personalized support system that goes beyond the usual care. Unlike standard treatments that focus solely on medical management, Family Navigation involves guiding families through understanding and implementing lifestyle changes, which can be crucial for sustainable weight management. This method aims to empower families with tailored resources and continuous support, potentially leading to more effective and lasting results in managing childhood obesity.

What evidence suggests that Family Navigation is effective for reducing attrition in pediatric obesity management?

Studies have shown that Family Navigation (FN), which participants in this trial may receive, can improve families' access to health services and increase their satisfaction with care. This method has successfully enhanced treatment outcomes in various healthcare areas. Early findings suggest that FN might help families overcome obstacles to receiving necessary health services. By providing extra support, such as parking passes and helpful reminders, children in obesity management programs might attend more appointments and adhere better to their treatment plans. However, more research is needed to confirm if FN specifically reduces dropout rates in pediatric obesity management. ^{1 2 3 5 6}

Who Is on the Research Team?

Geoff Ball, PhD RD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

BMI ≥97th percentile

Have a primary caregiver (parent/guardian) agree to participate

I am between 6 and 17 years old.

Exclusion Criteria

I, as a caregiver, can communicate in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Family Navigation (FN) + Usual Care or Usual Care only for 12 months

12 months

Regular visits with navigators and clinicians, frequency varies

Follow-up

Participants are monitored for attrition and other outcomes post-treatment

6 months

Follow-up assessments at 3, 6, and 12 months post-baseline

What Are the Treatments Tested in This Trial?

Interventions

• Family Navigation
• Usual Care

Trial Overview 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.

How Is the Trial Designed?

Group I: Family Navigation + Usual Care Experimental Treatment 2 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 Care Active Control 1 Intervention

Participants assigned to this arm will standard pediatric obesity management only.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

The study involves 108 children aged 6-17 with obesity and their caregivers, who will be randomized to receive either Family Navigation (FN) combined with Usual Care or just Usual Care over a 12-month period, aiming to improve access and reduce attrition in obesity management.

Family Navigation is designed to enhance care access through logistical and relational strategies, and the study will evaluate its acceptability and effectiveness in reducing barriers to treatment, with data collected at multiple time points to inform future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-center, randomized, 12-month, parallel-group, feasibility study to assess the acceptability and preliminary impact of family navigation plus usual care versus usual care on attrition in managing pediatric obesity: a study protocol. Ball, GDC., O'Neill, MG., Noor, R., et al.[2023]

Home visitation as part of a childhood obesity program was seen as convenient and effective for engaging families and promoting behavior change, according to insights from 25 parents and 3 patient navigators.

However, challenges such as scheduling difficulties and discomfort with home visits were noted, suggesting that future strategies could include conducting visits in pairs or integrating group classes for additional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Visitations for Delivering an Early Childhood Obesity Intervention in Denver: Parent and Patient Navigator Perspectives. Knierim, SD., Moore, SL., Raghunath, SG., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10524045/

Adolescent and Caregiver Perspectives on Family ... We interviewed families to explore their views on the role of family navigation (FN) to improve access to and use of health services for managing pediatric ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36691103/

A multi-center, randomized, 12-month, parallel-group, ... Family Navigation (FN) can improve access, satisfaction with care, and treatment outcomes in diverse areas of healthcare. To help our team ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2805906

Family-Based Behavioral Treatment for Childhood Obesity ... The intervention led to improved weight outcomes over 24 months for children. In addition, family-based treatment had similar benefits for ...

4. sciencemediacentre.es sciencemediacentre.es/en/programs-focused-parents-are-insufficient-prevent-childhood-obesity-according-meta-analysis

Childhood obesity: family intervention is not enough Overall, the study found no evidence of the effectiveness of paret-focused interventions on improving adiposity or other secondary outcomes.

5. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-023-01246-w

A multi-center, randomized, 12-month, parallel-group ... Our trial will assess the feasibility of FN to address attrition in managing pediatric obesity. Study data will inform a future effectiveness trial.

6. withpower.com withpower.com/trial/phase-obesity-child-5-2022-8f1e3

Family Navigation for Childhood Obesity · Info for Participants Research suggests that Family Navigation can improve access to healthcare and satisfaction with care, which may lead to better treatment outcomes for managing ...