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

108 Participants Needed

Trial Summary

What is the purpose of this trial?

Our feasibility study will assess the feasibility and acceptability of Family Navigation (FN) to address attrition (dropout) in pediatric obesity management. Results from this study will help our team to plan a large randomized clinical trial to test the effectiveness of FN in reducing attrition. The investigators will enroll 108 6-to-17-year-olds enrolled in pediatric obesity management clinics in Calgary, AB and Mississauga, ON (Canada). One-half of the children will receive Family Navigation (FN) + Usual Care (UC) for 12 months; the other half will receive Usual Care only for 12 months. Overall, the study will take 2.5 years to complete. For children receiving FN, trained navigators will work with children and their families to reduce barriers that limit their access to health services and support. Navigators will offer extra services and resources, such as parking passes for clinic appointments and supportive text messages between appointments. FN is designed to complement the obesity management (Usual Care) received by children and their families. A Steering Committee with children, caregivers, clinicians, and researchers will be created to refine and improve our FN intervention throughout the study. By having better access to care, children and their families working with navigators may be less likely to drop out and more likely to attend more treatment appointments. Ultimately, the participants may be more likely to achieve success in managing obesity.

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 data supports the effectiveness of the treatment Family Navigation for Childhood Obesity?

Research suggests that Family Navigation can improve access to healthcare and satisfaction with care, which may lead to better treatment outcomes for managing pediatric obesity. Families reported that Family Navigation could help them attend appointments consistently by providing practical support like appointment reminders and transportation assistance, which are crucial for long-term obesity management. ^{1 2 3 4 5}

Is Family Navigation safe for managing childhood obesity?

The research does not specifically address safety concerns related to Family Navigation for childhood obesity, but it highlights logistical challenges and the need for additional support during home visits, which could imply potential safety considerations. ^{1 2 3 4 6}

How is the Family Navigation treatment for childhood obesity different from other treatments?

Family Navigation is unique because it focuses on improving access to healthcare and supporting families in managing pediatric obesity through practical strategies like appointment reminders and transportation support, provided by empathetic healthcare professionals. This approach aims to reduce attrition (dropout) rates by addressing barriers that prevent families from continuing care, which is not typically a focus of standard treatments. ^{1 2 4 7 8}

Research Team

Geoff Ball, PhD RD

Principal Investigator

University of Alberta

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England 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. [2023]

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

Adolescent and Caregiver Perspectives on Family Navigation to Improve Healthcare Access and Use for Managing Pediatric Obesity. [2023]

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

Improving Care for Childhood Obesity: A Quality Improvement Initiative. [2022]

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

Home Visitations for Delivering an Early Childhood Obesity Intervention in Denver: Parent and Patient Navigator Perspectives. [2021]

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

Parent Recommendations to Enhance Enrollment in Multidisciplinary Clinical Care for Pediatric Weight Management. [2018]

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

The Families Improving Health Together (FIT) Program: Initial evaluation of retention and research in a multispecialty clinic for children with obesity. [2023]

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

Weighing risk: the expert committee's recommendations in practice. [2016]

8. Switzerland pubmed.ncbi.nlm.nih.gov

STEP IN: Supporting Together Exercise and Play and Improving Nutrition; a Feasibility Study of Parent-Led Group Sessions and Fitness Trackers to Improve Family Healthy Lifestyle Behaviors in a Low-Income, Predominantly Black Population. [2023]