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Social Determinants of Global Pediatric Diabetes (DESIDE)

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ClinicalTrials.gov Identifier: NCT04272099
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
julia.vonoettingen, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.


Condition or disease Intervention/treatment
Diabetes Mellitus Other: Administration of standardized questionnaires Device: Physical activity tracker Other: Dietary log

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Study Type : Observational
Estimated Enrollment : 79 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Individual and Social Determinants of Health in Global Pediatric Diabetes Care Delivery - a Participatory Search for Barriers and Opportunities
Actual Study Start Date : June 20, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

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.
Other: Administration of standardized questionnaires
Administration of questionnaires assessing subjective socioeconomic status (SES), health literacy, perceived health, health related quality of life, self-esteem and diabetes self-efficacy

Device: Physical activity tracker
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.

Other: Dietary log
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).
Other: Administration of standardized questionnaires
Administration of questionnaires assessing subjective socioeconomic status (SES), health literacy, perceived health, health related quality of life, self-esteem and diabetes self-efficacy




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04272099


Contacts
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Contact: Julia von Oettingen, MD PhD MMSc 514-412-4400 ext 22865 julia.vonoettingen@mcgill.ca

Locations
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Canada, Quebec
Centre intégré universitaire de santé et de services sociaux de l'Est-de-l'Île-de-Montréal Not yet recruiting
Montréal, Quebec, Canada, H1T 2M4
Contact: Laurent Legault, MD FRCP PhD    514-412-4400 ext 63872    laurent.legault@muhc.mcgill.ca   
CHU Sainte-Justine Not yet recruiting
Montréal, Quebec, Canada, H3T 1C5
Contact: Melanie Henderson, MD FRCPC PhD    514-345-4735    melanie.henderson.hsj@gmail.com   
Sub-Investigator: Louis Geoffroy, MD FRCPC PhD         
Montreal Children's Hospital Not yet recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Julia von Oettingen    514-412-4400 ext 22865    julia.vonoettingen@mcgill.ca   
Haiti
Kay Mackenson Pediatric Clinic Recruiting
Montrouis, Artibonite, Haiti
Contact: Ketly Altenor, MD    +509-3697-0747    info@kaymackenson.org   
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Julia von Oettingen, MD PhD MMSc MUHC-RIMUCH

Additional Information:
Publications:
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Responsible Party: julia.vonoettingen, Assistant Professor at McGill University, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT04272099    
Other Study ID Numbers: 2018-3350
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by julia.vonoettingen, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Adolescent
Child
Quality of Life
Self Efficacy
Haiti
Emigrants and Immigrants
Canada
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases