Screening and addressing social needs of children and families enrolled in a pediatric weight management program: a protocol for a pilot randomized controlled trial

Gita Wahi, Stacey Marjerrison, Carline Gutierrez, Kimberley Krasevich, Katherine M Morrison, Lehana Thabane, Gita Wahi, Stacey Marjerrison, Carline Gutierrez, Kimberley Krasevich, Katherine M Morrison, Lehana Thabane

Abstract

Background: There is a paucity of evidence to support interventions that address the social needs of children and families with chronic medical conditions. The primary objective of this pilot randomized controlled trial (RCT) is to assess the feasibility of an intervention that screens for and addresses the social needs of children and families enrolled in a pediatric weight management clinic.

Method: We will conduct a single-center, pilot RCT of 40 families with children enrolled in a pediatric weight management program at a tertiary children's hospital in Ontario, Canada. Families who are experiencing unmet social needs will be randomized to either a community navigator or self-navigation of community resources. The primary feasibility outcomes and criteria for success include the following: (1) recruitment rates, will be successful if 80% of our target sample is met in the 6 months of recruitment; (2) uptake of intervention, will be considered successful if > 80% of families complete the intervention; and (3) follow-up of participants, will be considered successful if > 90% of participants complete all the study visits. The secondary outcomes include estimating the preliminary effects on body mass index, body composition, and quality of life at 6 months. The analysis of feasibility outcomes will be based on descriptive statistics, and analysis of secondary clinical outcomes will be reported as estimates of effect. We will not perform tests of significance since these analyses are purely exploratory.

Discussion: This study is important because it will aim to improve the treatment of pediatric obesity by testing the feasibility of an intervention that addresses unmet social needs.

Trial registration: ClinicalTrias.gov : NCT04711707 (Registered January 13, 2021).

Keywords: Pediatric obesity; Screening; Social needs.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

References

    1. Obesity. Accessed April 19, 2021.
    1. Fazalullasha F, Taras J, Morinis J, et al. From office tools to community supports: the need for infrastructure to address the social determinants of health in paediatric practice. Paediatr Child Health. 2014;19(4):195–199. doi: 10.1093/pch/19.4.195.
    1. Social determinants of health. Accessed July 22, 2021.
    1. Oliver LN, Hayes MV. Neighbourhood socio-economic status and the prevalence of overweight Canadian children and youth. Can J Public Health. 2005;96(6):415–420. doi: 10.1007/BF03405180.
    1. 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;11(5, Supplement 1):1–51. doi: 10.1016/j.orcp.2016.04.001.
    1. Hadjiyannakis S, Ibrahim Q, Li J, et al. 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;3(6):398–407. doi: 10.1016/S2352-4642(19)30056-2.
    1. Government of Canada Statistics Canada. The Daily — Canadian Income Survey, 2017. Published February 26, 2019. Accessed July 22, 2021.
    1. Public Health Agency of Canada. Social determinants of health. Accessed April 19, 2021.
    1. Andermann A. Screening for social determinants of health in clinical care: moving from the margins to the mainstream. Public Health Rev. 2018;39(1). 10.1186/s40985-018-0094-7.
    1. American Academy of Pediatrics Poverty and child health in the United States. Pediatrics. 2016;137(4):e20160339. doi: 10.1542/peds.2016-0339.
    1. Gottlieb LM, Wing H, Adler NE. A systematic review of interventions on patients’ social and economic needs. Am J Prev Med. 2017;53(5):719–729. doi: 10.1016/j.amepre.2017.05.011.
    1. Eder M, Henninger M, Durbin S, et al. Screening and interventions for social risk factors: technical brief to support the US Preventive Services Task Force. JAMA. 2021;326(14):1416–1428. doi: 10.1001/jama.2021.12825.
    1. 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;30(5):e11–e15. doi: 10.1016/j.pedhc.2016.05.003.
    1. Gottlieb LM, Hessler D, Long D, et al. Effects of social needs screening and in-person service navigation on child health: a randomized clinical trial. JAMA Pediatr. 2016;170(11):e162521. doi: 10.1001/jamapediatrics.2016.2521.
    1. Garg A, Toy S, Tripodis Y, Silverstein M, Freeman E. Addressing social determinants of health at well child care visits: a cluster RCT. Pediatrics. 2015;135(2):e296–e304. doi: 10.1542/peds.2014-2888.
    1. . Find programs and services in your community. . Accessed 15 Oct 2019.
    1. Chen E, Martin AD, Matthews KA. Trajectories of socioeconomic status across children’s lifetime predict health. Pediatrics. 2007;120(2):e297–e303. doi: 10.1542/peds.2006-3098.
    1. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol. 2013;66(2):197–201. doi: 10.1016/j.jclinepi.2012.09.002.
    1. Public Health Ontario. Ontario Marginalization Index. Accessed April 19, 2021.
    1. Colvin JD, Bettenhausen JL, Anderson-Carpenter KD, et al. Multiple behavior change intervention to improve detection of unmet social needs and resulting resource referrals. Acad Pediatr. 2016;16(2):168–174. doi: 10.1016/j.acap.2015.06.001.
    1. Altman DG, Schulz KF. Statistics notes: concealing treatment allocation in randomised trials. BMJ. 2001;323(7310):446–447. doi: 10.1136/bmj.323.7310.446.
    1. Cost KT, Crosbie J, Anagnostou E, et al. Mostly worse, occasionally better: impact of COVID-19 pandemic on the mental health of Canadian children and adolescents. Eur Child Adolesc Psychiatry. Published online February 26. 2021. 10.1007/s00787-021-01744-3.
    1. Sharma SV, Chuang RJ, Rushing M, et al. Social determinants of health–related needs during COVID-19 among low-income households with children. Prev Chronic Dis. 2020;17:E119. doi: 10.5888/pcd17.200322.
    1. Eneriz-Wiemer Monica, Sanders Lee M., Barr Donald A., Mendoza Fernando S. Parental Limited English Proficiency and Health Outcomes for Children With Special Health Care Needs: A Systematic Review. Academic Pediatrics. 2014;14(2):128–136. doi: 10.1016/j.acap.2013.10.003.
    1. Khan Alisa, Yin H. Shonna, Brach Cindy, Graham Dionne A., Ramotar Matthew W., Williams David N., Spector Nancy, Landrigan Christopher P., Dreyer Benard P. Association Between Parent Comfort With English and Adverse Events Among Hospitalized Children. JAMA Pediatrics. 2020;174(12):e203215. doi: 10.1001/jamapediatrics.2020.3215.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe