Clinical trial NCT04711707: Addressing the Social Needs of Children With Obesity
Official title: Addressing the Social Needs of Children Attending a Weight Management Program: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Childhood
Keywords: Social Determinants of Health
Obesity
Child Health
Social needs
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants who screen positive for social needs will be randomized to receive one of two possible interventions. An allocation ratio of 1:1 with random permuted blocks of varying size will be used. Random block size will help to ensure that investigators or outcome assessors will not be able to decipher the block size and anticipate future allocations. Allocation concealment is the process that prevents any trial participant or investigator from knowing in advance the treatment to which subjects will be assigned and seeks to prevent selection bias.
Primary purpose: SCREENING

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.

Detailed description: Addressing the social needs of children attending a weight management program. The specific aims of this pilot randomized controlled trial are the following:

1. To determine the feasibility of implementation and delivery of a screening-referral intervention versus usual care to address social needs of children with obesity enrolled in a pediatric weight management program at McMaster Children's Hospital, which will include recruitment rates, uptake of the intervention, and follow-up of participants.
2. To understand impact on health outcomes of a screening-referral intervention versus usual care to address social needs of children with obesity enrolled in a pediatric weight management program including change in i) body mass index z score (zBMI); ii) change in body composition; and iii) change in health-related quality of life.

Hypothesis: We hypothesize that health outcomes of children with obesity are connected to the social determinants of health, and that an intervention which screens for and refers to community supports will improve child obesity outcomes.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Rates
timeFrame: 6 months
measure: Uptake of Intervention
timeFrame: 6 months
measure: Follow-up of Participants
timeFrame: 6 months
Secondary outcomes:
measure: Change in Body Mass Index Z-Score
timeFrame: 6 Months
measure: Change in Body Composition
timeFrame: 6 Months
measure: Change in Quality of Life
timeFrame: 6 Months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Kimberley Krasevich
state: Ontario
Study officials:
affiliation: McMaster Children's Hospital
name: Gita Wahi, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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citation: Wahi G, Marjerrison S, Gutierrez C, Krasevich K, Morrison KM, Thabane L. Screening and addressing social needs of children and families enrolled in a pediatric weight management program: a protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2022 Jun 18;8(1):129. doi: 10.1186/s40814-022-01080-6.