Addressing the Social Needs of Children With Obesity

Addressing the Social Needs of Children Attending a Weight Management Program: a Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Childhood
• Intervention / Treatment: Other: Community navigator; Other: Self-Navigation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gita Wahi, MD, MSc; Phone Number: 905-521-2100; Email: wahig@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L9C3L7
      • Recruiting
      • Kimberley Krasevich
      • Contact: Kimberley Krasevich, BSc,BEd; Phone Number: 73517 9055212100; Email: krasevich@hhsc.ca
      • Contact: Wahi Gita, MD,MSc; Phone Number: 9055212100; Email: wahig@mcmaster.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community navigator; This group is guided through the resources and provided bi-monthly support with a community navigator	Other: 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.
Other: Self-Navigation; This group receives the social needs resources to self-navigation	Other: Self-Navigation; The control group will receive an electronic or paper copy of community resources that address the identified social needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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.	6 months
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 Months
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.	6 Months
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).	6 Months

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Gita Wahi, MD, MSc, McMaster Children's Hospital

Publications and helpful links

General Publications

• Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
• Gottlieb LM, Wing H, Adler NE. A Systematic Review of Interventions on Patients' Social and Economic Needs. Am J Prev Med. 2017 Nov;53(5):719-729. doi: 10.1016/j.amepre.2017.05.011. Epub 2017 Jul 5.
• Oliver LN, Hayes MV. Neighbourhood socio-economic status and the prevalence of overweight Canadian children and youth. Can J Public Health. 2005 Nov-Dec;96(6):415-20. doi: 10.1007/BF03405180.
• Hadjiyannakis S, Ibrahim Q, Li J, Ball GDC, Buchholz A, Hamilton JK, Zenlea I, Ho J, Legault L, Laberge AM, Thabane L, Tremblay M, Morrison KM. Obesity class versus the Edmonton Obesity Staging System for Pediatrics to define health risk in childhood obesity: results from the CANPWR cross-sectional study. Lancet Child Adolesc Health. 2019 Jun;3(6):398-407. doi: 10.1016/S2352-4642(19)30056-2. Epub 2019 Apr 3.
• COUNCIL ON COMMUNITY PEDIATRICS. Poverty and Child Health in the United States. Pediatrics. 2016 Apr;137(4):e20160339. doi: 10.1542/peds.2016-0339. Epub 2016 Mar 9.
• Fox CK, Cairns N, Sunni M, Turnberg GL, Gross AC. Addressing Food Insecurity in a Pediatric Weight Management Clinic: A Pilot Intervention. J Pediatr Health Care. 2016 Sep-Oct;30(5):e11-5. doi: 10.1016/j.pedhc.2016.05.003. Epub 2016 Jun 16.
• Fazalullasha F, Taras J, Morinis J, Levin L, Karmali K, Neilson B, Muskat B, Bloch G, Chan K, McDonald M, Makin S, Ford-Jones EL. From office tools to community supports: The need for infrastructure to address the social determinants of health in paediatric practice. Paediatr Child Health. 2014 Apr;19(4):195-9. doi: 10.1093/pch/19.4.195.
• Kenyon C, Sandel M, Silverstein M, Shakir A, Zuckerman B. Revisiting the social history for child health. Pediatrics. 2007 Sep;120(3):e734-8. doi: 10.1542/peds.2006-2495. No abstract available.
• Colvin JD, Bettenhausen JL, Anderson-Carpenter KD, Collie-Akers V, Plencner L, Krager M, Nelson B, Donnelly S, Simmons J, Higinio V, Chung PJ. Multiple Behavior Change Intervention to Improve Detection of Unmet Social Needs and Resulting Resource Referrals. Acad Pediatr. 2016 Mar;16(2):168-74. doi: 10.1016/j.acap.2015.06.001. Epub 2015 Jul 14.
• Chen E, Martin AD, Matthews KA. Trajectories of socioeconomic status across children's lifetime predict health. Pediatrics. 2007 Aug;120(2):e297-303. doi: 10.1542/peds.2006-3098. Epub 2007 Jul 2.
• Ligthart KAM, Buitendijk L, Koes BW, van Middelkoop M. The association between ethnicity, socioeconomic status and compliance to pediatric weight-management interventions - A systematic review. Obes Res Clin Pract. 2017 Sep-Oct;11(5 Suppl 1):1-51. doi: 10.1016/j.orcp.2016.04.001. Epub 2016 Apr 20.
• 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.

Helpful Links

• 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.
• 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.
• Access to an electronic database of Ontario's government and community based social services.
• Public health agency of Canada produced this website, providing information to help plan ways to address the social determinants of health.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Social Determinants of Health; Child Health; Social needs
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 12697

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No