Addressing the Social Needs of Children With Obesity
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obesity, Childhood
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: Single (Outcomes Assessor)Masking Description: Data analysts will be blind to the group allocation. Group allocation will be concealed until the final data analysis is performed. Families, research staff and clinical staff will not be blinded to the group allocation.Primary Purpose: Screening
Participation Requirements
- Age
- Between 2 years and 18 years
- Gender
- Both males and females
Description
Addressing the social needs of children attending a weight management program. The specific aims of this pilot randomized controlled trial are the following: To determine the feasibility of implementation and delivery of a screening-referral intervention versus usual care to address social needs of ...
Addressing the social needs of children attending a weight management program. The specific aims of this pilot randomized controlled trial are the following: 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. 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.
Tracking Information
- NCT #
- NCT04711707
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Gita Wahi, MD, MSc McMaster Children's Hospital
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