Social Determinants of Global Pediatric Diabetes
DESIDE
Individual and Social Determinants of Health in Global Pediatric Diabetes Care Delivery - a Participatory Search for Barriers and Opportunities
1 other identifier
observational
79
2 countries
4
Brief Summary
There is little data from low-income countries on setting and culture specific perception of childhood diabetes and disease specific stressors including stigma, and how these may affect disease related quality of life, coping strategies, self-efficacy and glycemic control. The goal of this study is to understand how socioeconomic, psychosocial, cultural, and diet and activity related factors in children and adolescents with diabetes in Haiti relate to quality of life, self-efficacy and glycemic control, and comparing the factor analysis to immigrant children of Haitian ancestry with diabetes living in Montreal. An innovative, participatory research approach will allow for a holistic evaluation of modifiable barriers to optimal pediatric diabetes care delivery in resource limited settings, while providing translational information for care delivery of diabetes in underserved, immigrant populations in high-income settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2017
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2017
CompletedFirst Submitted
Initial submission to the registry
February 13, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedOctober 24, 2022
October 1, 2022
5.9 years
February 13, 2020
October 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Socioeconomic status, health literacy level, and diabetes self-efficacy in PG1 and PG2
ZIP code-based SES indicators and questionnaires on health literacy, and diabetes self-efficacy
These variables will be assessed cross-sectionally at time of enrolment
The psychosocial and physical health status of PG1
Questionnaires on perceived health, health-related quality of life, and self-esteem
These variables will be assessed cross-sectionally at time of enrolment
Diet and activity related lifestyle habits of children with diabetes of PG1
Collection of data on dietary composition, meal distribution pattern, and activity patterns including walking distance, calorie expenditure, sedentary time and sleep.
These variables will be assessed prospectively over three months during follow-up from time of enrolment
Glycemic control, health related quality of life and clinical phenotypes of PG1
Extraction of clinical records, data on the date of diagnosis, clinical presentation at diagnosis, hemoglobin A1C measurements over time, most recent weight, height, body mass index (BMI) and total daily insulin dose. Questionnaire on health-related quality of life. Data collection on blood glucose monitoring frequency and distribution, blood glucose values, as well as insulin dosing and injections.
Retrospective data from time of diagnosis, cross-sectional at time of enrolment and prospective monitoring over three months from time of diabetes diagnosis and over three months from time of enrolment
Secondary Outcomes (1)
Psychometric evaluation of the health literacy, health-related quality of life, self-esteem and self-efficacy questionnaires in PG1
Cross-sectional assessment at time of enrolment
Study Arms (2)
PG1 (patients with diabetes 0-25 years of age)
Patients 0 to 25 years of age, with a diagnosis of diabetes that are either followed at Kay Mackenson Pediatric Clinic, Haiti, or who are of Haitian ancestry, defined as both maternal and paternal grandparents being born in Haiti, and attend one of the three diabetes clinics in Montreal.
PG2 (patient's principal caregiver)
The patient's principal caregiver (a parent of legal guardian).
Interventions
Administration of questionnaires assessing subjective socioeconomic status (SES), health literacy, perceived health, health related quality of life, self-esteem and diabetes self-efficacy
PG1 will be asked to wear a physical activity tracker for one week to monitor activity patterns including walking distance, calorie expenditure, sedentary time and sleep.
PG1 (or PG2 as proxies when appropriate) will report to a study coordinator via phone a full dietary log of PG1 once per week on rotating days of the week for three weeks.
Eligibility Criteria
The study will take place at 2 sites: * Haiti, through the Kay Mackenson Clinic (KMC) in Montrouis (with a catchment area across the country), * Montreal, through the diabetes clinics of the Montreal Children's Hospital (MCH), the CHU Sainte-Justine Hospital (CHUSJ) and the Centre intégré universitaire de santé et de services sociaux de l'Est-de-l'Île-de-Montréal (CIUSSS) in Montreal, Canada. Participants will be enrolled from each local clinic.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Centre intégré universitaire de santé et de services sociaux de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, H1T 2M4, Canada
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1, Canada
Kay Mackenson Pediatric Clinic
Montrouis, Artibonite, Haiti
Related Publications (6)
Marshall SL, Edidin D, Sharma V, Ogle G, Arena VC, Orchard T. Current clinical status, glucose control, and complication rates of children and youth with type 1 diabetes in Rwanda. Pediatr Diabetes. 2013 May;14(3):217-26. doi: 10.1111/pedi.12007. Epub 2012 Dec 28.
PMID: 23279222BACKGROUNDMarshall SL, Edidin DV, Arena VC, Becker DJ, Bunker CH, Gishoma C, Gishoma F, LaPorte RE, Kaberuka V, Ogle G, Sibomana L, Orchard TJ. Glucose control in Rwandan youth with type 1 diabetes following establishment of systematic, HbA1c based, care and education. Diabetes Res Clin Pract. 2015 Jan;107(1):113-22. doi: 10.1016/j.diabres.2014.09.045. Epub 2014 Oct 7.
PMID: 25458328BACKGROUNDBeaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
PMID: 11124735BACKGROUNDPiloya-Were T, Sunni M, Ogle GD, Moran A. Childhood diabetes in Africa. Curr Opin Endocrinol Diabetes Obes. 2016 Aug;23(4):306-11. doi: 10.1097/MED.0000000000000262.
PMID: 27228228BACKGROUNDAdler NE, Epel ES, Castellazzo G, Ickovics JR. Relationship of subjective and objective social status with psychological and physiological functioning: preliminary data in healthy white women. Health Psychol. 2000 Nov;19(6):586-92. doi: 10.1037//0278-6133.19.6.586.
PMID: 11129362BACKGROUNDGoodman E, Adler NE, Kawachi I, Frazier AL, Huang B, Colditz GA. Adolescents' perceptions of social status: development and evaluation of a new indicator. Pediatrics. 2001 Aug;108(2):E31. doi: 10.1542/peds.108.2.e31.
PMID: 11483841BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julia von Oettingen, MD PhD MMSc
MUHC-RIMUCH
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor at McGill University
Study Record Dates
First Submitted
February 13, 2020
First Posted
February 17, 2020
Study Start
June 20, 2017
Primary Completion
May 1, 2023
Study Completion
June 1, 2023
Last Updated
October 24, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share