Diabetes MellitusDESIDENCT04272099
Social Determinants of Global Pediatric Diabetes
An observational study of Diabetes Mellitus, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 25 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Administration of standardized questionnaires, Physical activity tracker and Dietary log
- Type of treatment
- Medical device
- How many people
- 79 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 20 Jun 2017to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 25 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Canada3 sites, 3 recruiting
- Recruiting
Centre intégré universitaire de santé et de services sociaux de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, H1T 2M4
Laurent Legault, MD FRCP PhD, 514-412-4400 ext. 63872, laurent.legault@muhc.mcgill.ca
- Recruiting
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Melanie Henderson, MD FRCPC PhD, 514-345-4735, melanie.henderson.hsj@gmail.com
Louis Geoffroy, MD FRCPC PhD
- Not yet recruiting
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
Julia von Oettingen, 514-412-4400 ext. 22865, julia.vonoettingen@mcgill.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Administration of standardized questionnaires, Physical activity tracker, Dietary log
- Keywords
- Adolescent, Child, Quality of Life, Self Efficacy, Haiti, Emigrants and Immigrants, Canada
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of standardized questionnairesOther
Administration of questionnaires assessing subjective socioeconomic status (SES), health literacy, perceived health, health related quality of life, self-esteem and diabetes self-efficacy
Physical activity trackerDevice
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.
Dietary logOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Administration of standardized questionnaires; Device: Physical activity tracker; Other: Dietary log | |
| PG2 (patient's principal caregiver) | The patient's principal caregiver (a parent of legal guardian). Receives: Other: Administration of standardized questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Standardized questionnaires
Measured: Cross-sectional assessment at time of enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start20 Jun 2017
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, julia.vonoettingen, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Julia von Oettingen, MD PhD MMSc, Principal investigator, MUHC-RIMUCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272099
- Sponsor's protocol ID
- 2018-3350
- Acronym
- DESIDE
- Status last verified
- Oct 2022
- First submitted
- 13 Feb 2020
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23279222Marshall 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.
PubMed 25458328Beaton 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.
PubMed 11124735Piloya-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.
PubMed 27228228Adler 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.
PubMed 11129362Goodman 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.
PubMed 11483841
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual and Social Determinants of Health in Global Pediatric Diabetes Care Delivery - a Participatory Search for Barriers and Opportunities
- ClinicalTrials.gov ID
- NCT04272099
- Acronym / sponsor ID
- DESIDE / 2018-3350
- Conditions
- Diabetes Mellitus
- Keywords
- Adolescent, Child, Quality of Life, Self Efficacy, Haiti, Emigrants and Immigrants, Canada
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PG1 (patients with diabetes 0-25 years of age) | – | Other: Administration of standardized questionnaires, Device: Physical activity tracker, Other: Dietary logPatients 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) | – | Other: Administration of standardized questionnairesThe patient's principal caregiver (a parent of legal guardian). |
Who may qualify
- Ages
- 0 to 25 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of standardized questionnairesAdministration of questionnaires assessing subjective socioeconomic status (SES), health literacy, perceived health, health related quality of life, self-esteem and diabetes self-efficacy | Other | PG1 (patients with diabetes 0-25 years of age), PG2 (patient's principal caregiver) |
| Physical activity trackerPG1 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. | Device | PG1 (patients with diabetes 0-25 years of age) |
| Dietary logPG1 (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. | Other | PG1 (patients with diabetes 0-25 years of age) |
Primary outcome
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
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
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.
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Background: PubMed 23279222Marshall 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.
- Background: PubMed 25458328Marshall 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.
- Background: PubMed 11124735Beaton 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.
- Background: PubMed 27228228Piloya-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.
- Background: PubMed 11129362Adler 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.
- Background: PubMed 11483841Goodman 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.
- International Diabetes Federation. IDF World Diabetes Atlas 2015Link provided by the sponsor.
- World Food Program Haiti. Haiti Urban Food Security Assessment. 2016.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia von Oettingen, MD PhD MMSc principal investigator
MUHC-RIMUCH
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, Haiti. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia von Oettingen, MD PhD MMSc (514-412-4400 ext. 22865, julia.vonoettingen@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04272099, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.