Addressing the Social Needs of Children With Obesity

Obesity, Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04711707
• Other study ID #: 12697
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: Hamilton Health Sciences Corporation
• Contact: Gita Wahi, MD, MSc
• Phone: 905-521-2100
• Email: wahig[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

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

Locations

Country	Name	City	State
Canada	Kimberley Krasevich	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (11)

Chen E, Martin AD, Matthews KA. Trajectories of socioeconomic status across children's lifetime predict health. Pediatrics. 2007 Aug;120(2):e297-303. Epub 2007 Jul 2. — View Citation

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. — View Citation

COUNCIL ON COMMUNITY PEDIATRICS. Poverty and Child Health in the United States. Pediatrics. 2016 Apr;137(4). pii: e20160339. doi: 10.1542/peds.2016-0339. Epub 2016 Mar 9. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Kenyon C, Sandel M, Silverstein M, Shakir A, Zuckerman B. Revisiting the social history for child health. Pediatrics. 2007 Sep;120(3):e734-8. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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

External Links

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