Addressing the Social Needs of Children With Obesity
Primary Purpose
Obesity, Childhood
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Community navigator
Self-Navigation
Sponsored by
About this trial
This is an interventional screening trial for Obesity, Childhood focused on measuring Social Determinants of Health, Obesity, Child Health, Social needs
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
Sites / Locations
- Kimberley KrasevichRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Community navigator
Self-Navigation
Arm Description
This group is guided through the resources and provided bi-monthly support with a community navigator
This group receives the social needs resources to self-navigation
Outcomes
Primary Outcome Measures
Recruitment Rates
Recruitment rate refers to the number of participants enrolled and is measured by the number of consent forms signed or implied. Recruitment will be successful if 80% of our target sample is met.
Uptake of Intervention
Uptake of the intervention refers to the number of enrolled families who completed all aspect of the intervention. Elements that are part of the uptake include: social history following enrollment as well as the quality of life questionnaires and use of service questionnaire at enrolment and 6-months. Uptake will be considered successful if >80% of families complete the intervention.
Follow-up of Participants
Follow-up of participants refers to the participants attending all of their scheduled study visits. The study will be considered successful if >90% of participants complete all study visits.
Secondary Outcome Measures
Change in Body Mass Index Z-Score
The body mass index Z-score (zBMI) is calculated using WHO growth charts, for age and sex. Height and weight of the child will be collected from the chart at baseline and from every visit the participant has in clinic until the end of the intervention. BMI will be calculated by dividing weight in kilograms by the square of the body height in metres squared.
Change in Body Composition
Body fat will be assessed at baseline and at the end of the intervention using the Quantum II BIA analyzer (RJL Systems). Bioelectrical impedance analysis (BIA) is non-invasive and portable. It measures electrical impedance of tissues by applying alternating current to the body tissues (not felt by the participant), which is used in regression equations to approximate body fat and fat free mass. This will be collected at baseline from the chart and from every visit the participant has in clinic until the end of the intervention.
Change in Quality of Life
Quality of life will be measured using the Pediatrics Quality of Life Inventory (PedsQL™). Both the patient and the parent or guardian will be asked to complete the PedsQL™. The minimum possible score for this inventory is 0 and the highest is 100. Higher scores indicate a better Health Related Quality of Life (HRQOL).
Full Information
NCT ID
NCT04711707
First Posted
January 13, 2021
Last Updated
April 26, 2021
Sponsor
Hamilton Health Sciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04711707
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamilton Health Sciences Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
Keywords
Social Determinants of Health, Obesity, Child Health, Social needs
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Community navigator
Arm Type
Experimental
Arm Description
This group is guided through the resources and provided bi-monthly support with a community navigator
Arm Title
Self-Navigation
Arm Type
Other
Arm Description
This group receives the social needs resources to self-navigation
Intervention Type
Other
Intervention Name(s)
Community navigator
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Self-Navigation
Intervention Description
The control group will receive an electronic or paper copy of community resources that address the identified social needs.
Primary Outcome Measure Information:
Title
Recruitment Rates
Description
Recruitment rate refers to the number of participants enrolled and is measured by the number of consent forms signed or implied. Recruitment will be successful if 80% of our target sample is met.
Time Frame
6 months
Title
Uptake of Intervention
Description
Uptake of the intervention refers to the number of enrolled families who completed all aspect of the intervention. Elements that are part of the uptake include: social history following enrollment as well as the quality of life questionnaires and use of service questionnaire at enrolment and 6-months. Uptake will be considered successful if >80% of families complete the intervention.
Time Frame
6 months
Title
Follow-up of Participants
Description
Follow-up of participants refers to the participants attending all of their scheduled study visits. The study will be considered successful if >90% of participants complete all study visits.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Body Mass Index Z-Score
Description
The body mass index Z-score (zBMI) is calculated using WHO growth charts, for age and sex. Height and weight of the child will be collected from the chart at baseline and from every visit the participant has in clinic until the end of the intervention. BMI will be calculated by dividing weight in kilograms by the square of the body height in metres squared.
Time Frame
6 Months
Title
Change in Body Composition
Description
Body fat will be assessed at baseline and at the end of the intervention using the Quantum II BIA analyzer (RJL Systems). Bioelectrical impedance analysis (BIA) is non-invasive and portable. It measures electrical impedance of tissues by applying alternating current to the body tissues (not felt by the participant), which is used in regression equations to approximate body fat and fat free mass. This will be collected at baseline from the chart and from every visit the participant has in clinic until the end of the intervention.
Time Frame
6 Months
Title
Change in Quality of Life
Description
Quality of life will be measured using the Pediatrics Quality of Life Inventory (PedsQL™). Both the patient and the parent or guardian will be asked to complete the PedsQL™. The minimum possible score for this inventory is 0 and the highest is 100. Higher scores indicate a better Health Related Quality of Life (HRQOL).
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gita Wahi, MD, MSc
Phone
905-521-2100
Email
wahig@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gita Wahi, MD, MSc
Organizational Affiliation
McMaster Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kimberley Krasevich
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L9C3L7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberley Krasevich, BSc,BEd
Phone
9055212100
Ext
73517
Email
krasevich@hhsc.ca
First Name & Middle Initial & Last Name & Degree
Wahi Gita, MD,MSc
Phone
9055212100
Email
wahig@mcmaster.ca
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data collected for the purposes of this study will only be made available to the principal investigator, co-investigators and the research staff associated with the study.
Citations:
PubMed Identifier
16350864
Citation
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Results Reference
derived
Links:
URL
http://www.who.int/social_determinants/sdh_definition/en/
Description
The World Health Organization's Department of Social Determinants of Health webpage. It provides information about the social, physical and economic conditions in society that impact upon health.
URL
http://www.publichealthontario.ca/en/data-and-analysis/health-equity/ontario-marginalization-index
Description
Produced by Public Health Ontario, tt provides access to the Ontario Marginalization Index (ON-MARG). ON-MARG is a multifaceted index which measures axes of deprivation in Ontario, including economic, ethno-racial, age based and social.
URL
http://211ontario.ca/
Description
Access to an electronic database of Ontario's government and community based social services.
URL
http://cbpp-pcpe.phac-aspc.gc.ca/public-health-topics/social-determinants-of-health/
Description
Public health agency of Canada produced this website, providing information to help plan ways to address the social determinants of health.
Learn more about this trial
Addressing the Social Needs of Children With Obesity
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