- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04272099
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pediatric diabetes is a lifelong condition that affects an estimated 542,000 children under the age of 14 years worldwide, of whom the majority live in low- and middle-income countries. Epidemiological data from Haiti on the incidence and prevalence of diabetes in childhood are currently being collected. In Haiti, as in many other low-income countries, there is likely to be incomplete case ascertainment due to a lack of accurate and timely diagnosis. The investigators' group as well as others have observed remarkable differences in clinical presentation of childhood diabetes as compared to Caucasian patients. Presentations reminiscent of "atypical" diabetes, fibrocalculous pancreatitis, and malnutrition related diabetes seem to be more frequent. Many patients retain low exogenous insulin requirements past 5-10 years after initial diagnosis, suggesting much longer periods of residual endogenous insulin production as compared to Caucasian patients. Further, while complications of diabetes are considered a rarity in Caucasian patients, up to 20% of Haitian children and adolescents presenting with diabetes have eye complications (cataract and/or retinopathy) at the time of or within 2-3 years of diagnosis (unpublished data). Although genetic, environmental and immune factors have been hypothesized, the investigators do not currently understand the underlying etiology of these unusual phenotypes, and how those relate to glycemic control.
Limited data from sites in low-income countries where pediatric diabetes care has been established (including from Haiti) concerningly show that even when patients are regularly followed and insulin and diabetes care supplies are provided free of charge, glycemic control remains suboptimal. While psychosocial, sociocultural, educational and economic factors (including diet habits and food insecurity) are known to be associated with glycemic control, detailed evaluations from low-income countries on these factors and how they related to diabetes management in children are lacking. Similarly, 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.
Child and parent health literacy, defined as "the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions" has been shown to impact diabetes self-efficacy, including improved diabetes management and glycemic control. However, little is known about health literacy in children with diabetes and their families in resource limited settings, and its effect on diabetes care has not been evaluated in Haiti. The degree to which these complex, interrelated and dynamic factors affect long-term outcomes is not known.
Lastly, community, family and peer support is known to impact health outcomes in children with chronic disease. However, in many resource limited settings local support groups are not available, or are only offered at the diabetes clinic, which can be remote from the patient's home (many patients travel several hours to get to the diabetes clinic). It is unknown if the use of social networks for patients with diabetes in resource limited settings can improve perceived and objective health related outcomes.
The specific aims of this research project are:
- To evaluate the socioeconomic status (SES) of children with diabetes and their families in Haiti, and of Haitian immigrant children with diabetes in Montreal.
- To conduct a detailed psychosocial evaluation of participating children.
- To analyze macro- and micronutrient intake, dietary patterns, food security and physical activity patterns in participating children.
- To investigate perceptions and explanations of illness and health, and to assess health literacy and diabetes self-efficacy in participating children and caregivers.
- To evaluate how SES, psychosocial well-being, illness perception, health literally, self-efficacy and lifestyle habits relate to glycemic control and quality of life and clinical phenotypes.
The investigators will also assess how results compare between the two study sites.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Julia von Oettingen, MD PhD MMSc
- Phone Number: 22865 514-412-4400
- Email: julia.vonoettingen@mcgill.ca
Study Contact Backup
- Name: Jennifer Frei
- Phone Number: 438-349-9762
- Email: jennifer.frei@muhc.mcgill.ca
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H3T 1C5
- Recruiting
- CHU Sainte-Justine
-
Contact:
- Melanie Henderson, MD FRCPC PhD
- Phone Number: 514-345-4735
- Email: melanie.henderson.hsj@gmail.com
-
Sub-Investigator:
- Louis Geoffroy, MD FRCPC PhD
-
Montréal, Quebec, Canada, H1T 2M4
- Recruiting
- Centre intégré universitaire de santé et de services sociaux de l'Est-de-l'Île-de-Montréal
-
Contact:
- Laurent Legault, MD FRCP PhD
- Phone Number: 63872 514-412-4400
- Email: laurent.legault@muhc.mcgill.ca
-
Montréal, Quebec, Canada, H4A 3J1
- Not yet recruiting
- Montreal Children's Hospital
-
Contact:
- Julia von Oettingen
- Phone Number: 22865 514-412-4400
- Email: julia.vonoettingen@mcgill.ca
-
-
-
-
Artibonite
-
Montrouis, Artibonite, Haiti
- Completed
- Kay Mackenson Pediatric Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
Description
Inclusion Criteria:
- Inclusion criteria for PG1 are age 0-25 years, be of Haitian ancestry defined as having both maternal and paternal grandparents being born in Haiti, have a diagnosis of diabetes, and are enrolled in one of the two study site clinics.
- Inclusion criteria for PG2 are being the principal caregiver for a PG1.
Exclusion Criteria:
- Exclusion criteria for PG1 and PG2 are inability to provide informed consent (if 18 years or older) or inability of a parent or legal guardian to provide informed consent (if younger than 18 years).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
PG2 (patient's principal caregiver)
The patient's principal caregiver (a parent of legal guardian).
|
Administration of questionnaires assessing subjective socioeconomic status (SES), health literacy, perceived health, health related quality of life, self-esteem and diabetes self-efficacy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Socioeconomic status, health literacy level, and diabetes self-efficacy in PG1 and PG2
Time Frame: These variables will be assessed cross-sectionally at time of enrolment
|
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
Time Frame: These variables will be assessed cross-sectionally at time of enrolment
|
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
Time Frame: These variables will be assessed prospectively over three months during follow-up from time of enrolment
|
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
Time Frame: 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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychometric evaluation of the health literacy, health-related quality of life, self-esteem and self-efficacy questionnaires in PG1
Time Frame: Cross-sectional assessment at time of enrolment
|
Standardized questionnaires
|
Cross-sectional assessment at time of enrolment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Julia von Oettingen, MD PhD MMSc, MUHC-RIMUCH
Publications and helpful links
General Publications
- Beaton 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.
- 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.
- Marshall 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.
- Piloya-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.
- Adler 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.
- Goodman 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.
Helpful Links
- Gross domestic product ranking table
- International Diabetes Federation. IDF World Diabetes Atlas 2015
- U.S. Department of Health and Human Services. Quick Guide to Health Literacy. Fact Sheet.
- Kraus MW, Stephens NM. A Road Map for an Emerging Psychology of Social Class. Soc Personal Psychol Compass
- World Food Program Haiti. Haiti Urban Food Security Assessment. 2016.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-3350
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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