Recruiting

Observational Study

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT04711707

Conditions

Obesity, Childhood

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Interventions

Community navigator

Self-Navigation

Study Details

Brief summary:

This study aims to improve the treatment of a common, chronic health concern for children: obesity. It has the potential to improve the care we provide by testing an intervention that addresses social needs and the important upstream factors that influences health outcomes.

Conditions

Obesity, Childhood

Study ID

NCT04711707

Start date

Jan 25, 2021

Status verified date

Apr, 2021

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Enrollment in the weight management program

Exclusion Criteria:

  • Children in the care of child protection services and/or living in group or foster care. Children in these settings will not be living within typical family-systems to have social needs addressed by this intervention.
  • Parents who cannot read and write in English

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Community navigator

This group is guided through the resources and provided bi-monthly support with a community navigator

other: Self-Navigation

This group receives the social needs resources to self-navigation

Interventions

Community navigator

All patients who consent to participate in the study will complete a pediatric social history tool to identify social needs. The intervention group will receive support through a community navigator to guide and understand appropriate services for their specific needs. This arm will receive guidance and bimonthly check-ins.

Self-Navigation

The control group will receive an electronic or paper copy of community resources that address the identified social needs.

Primary outcome measure

  • Recruitment Rates [ Time Frame: 6 months ]
  • Uptake of Intervention [ Time Frame: 6 months ]
  • Follow-up of Participants [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Gita Wahi, MD, MSc

905-521-2100wahig@mcmaster.ca

Locations

Kimberley Krasevich

Recruiting

Hamilton, Ontario, Canada, L9C3L7

Contacts

Kimberley Krasevich, BSc,BEd

9055212100krasevich@hhsc.ca

Wahi Gita, MD,MSc

9055212100wahig@mcmaster.ca

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Apr 28, 2021

Last verified

Apr, 2021

Keywords

  • Social Determinants of Health
  • Obesity
  • Child Health
  • Social needs

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2021-04-28.