Addressing the Social Needs of Children With Obesity

NCT04711707 | Unknown

• 1 other identifier: 12697
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Social Determinants of Health; Obesity; Child Health; Social needs

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in Body Mass Index Z-Score

  6 Months

• Change in Body Composition

  6 Months

• Change in Quality of Life

  6 Months

Study Arms (2)

Community navigator

EXPERIMENTAL

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

Other: Community navigator

Self-Navigation

OTHER

This group receives the social needs resources to self-navigation

Other: Self-Navigation

Interventions

Community navigator OTHER

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.

Community navigator

Self-Navigation OTHER

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

Self-Navigation

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Enrollment in the weight management program

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Kimberley Krasevich

Hamilton, Ontario, L9C3L7, Canada

RECRUITING

Related Publications (14)

• 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.

  PMID: 16350864 BACKGROUND

• 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.

  PMID: 30952624 BACKGROUND

• 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.

  PMID: 26962238 BACKGROUND

• 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.

  PMID: 28688725 BACKGROUND

• 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.

  PMID: 27321679 BACKGROUND

• 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.

  PMID: 24855416 BACKGROUND

• 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.

  PMID: 17766513 BACKGROUND

• 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.

  PMID: 26183003 BACKGROUND

• 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.

  PMID: 11468499 BACKGROUND

• 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.

  PMID: 17606533 BACKGROUND

• 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.

  PMID: 27108215 BACKGROUND

• Wahi G, Marjerrison S, Gill S, Krasevich K, Morrison KM, Thabane L. Addressing unmet social needs of children with obesity: a pilot randomized controlled trial. Pilot Feasibility Stud. 2024 Nov 14;10(1):141. doi: 10.1186/s40814-024-01570-9.

  PMID: 39543718 DERIVED

• Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.

  PMID: 39382077 DERIVED

• 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.

  PMID: 35717284 DERIVED

Related 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.

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gita Wahi, MD, MSc

  McMaster Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gita Wahi, MD, MSc

CONTACT

905-521-2100; wahig@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: January 25, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)