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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04281069
Other study ID # OZ7880VLIR-S
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date May 18, 2022

Study information

Verified date May 2022
Source Universiteit Antwerpen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This South Initiative is the first step towards a long-term general objective that aims to improve the manage-ment of type 2 diabetes (T2D) and concurrently create jobs for health professionals in Eastern Morocco by developing a multidisciplinary approach in the management of T2D, based upon international guidelines but adapted to the regional socio-economic and cultural context, and with a focus on empowerment of Muslim women. The intermediate results of this SI project proposal are: 1) Facilitators and perceived barriers in female patients with T2D towards change to a healthier lifestyle are known. 2) Characteristics of patients with T2D in the region of Oujda (prevalence, lifestyle, age, gender,…) are analysed. 3) Master and bachelor students have gained experience by participating to relevant research. 4) All involved stakeholders shared existing and newly ac-quired knowledge and expertise. 5) Facilitators and perceived barriers in health professionals of different disciplines to work together in the management of T2D are known.


Description:

The ultimate objective is to help improve the quality of life and well-being of people living with diabetes in the Oujda region. This 2-year project will tackle the prerequisites and optimise the conditions needed to start a larger (TEAM) project. Afterwards, in the larger long-term (TEAM) project we will study the cost-of illness of T2D in Oujda, the effect of a cultural-sensitive multidisciplinary intervention for T2D and the cost-effectiveness of such an intervention. In doing so we hope to provide not only arguments from a health perspective for such an approach, but also from a quality of life and economic point of view. This is needed to persuade political decision makers to invest in sustainable innovation in health care. This could open the job market for many young physiotherapists, nutritionists and occupational therapists in health centres and primary care. The specific objectives of this 2-year SI project are 1) to know the characteristics of T2D patients in Oujda and their perceived barriers and benefits towards participation in a lifestyle program and 2) to improve communication and cooperation between health professionals of different disciplines treating patients with T2D. The intermediate results of this 2-year project are well defined and feasible (Annex 4). The two years of the SI project will be devoted to gathering information from diabetic women as well as from health profes-sionals, to creating a platform and to strengthening research capacities. The changes needed to reach the SI project outputs are related to 1) knowledge/capacity and 2) attitude/behaviour.


Recruitment information / eligibility

Status Completed
Enrollment 821
Est. completion date May 18, 2022
Est. primary completion date May 18, 2022
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - women - visiting the 35 local health centres and the CRD in Oujda - adult - Moroccan Exclusion Criteria: - male - no informed consent

Study Design


Locations

Country Name City State
Morocco Université Mohammed Premier Oujda (UMP) Faculté des Sciences, Département de Biologie Oujda Oujda Angad

Sponsors (4)

Lead Sponsor Collaborator
Universiteit Antwerpen Artesis Plantijn University College, Antwerp, Université Mohammed Premier, Oujda, Vliruos

Country where clinical trial is conducted

Morocco, 

References & Publications (5)

Abuyassin B, Laher I. Diabetes epidemic sweeping the Arab world. World J Diabetes. 2016 Apr 25;7(8):165-74. doi: 10.4239/wjd.v7.i8.165. Review. — View Citation

Lindström J, Peltonen M, Eriksson JG, Ilanne-Parikka P, Aunola S, Keinänen-Kiukaanniemi S, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study (DPS). Improved lifestyle and decreased diabetes risk over 13 years: long-term follow-up of the randomised Finnish Diabetes Prevention Study (DPS). Diabetologia. 2013 Feb;56(2):284-93. doi: 10.1007/s00125-012-2752-5. Epub 2012 Oct 24. — View Citation

Palmer AJ, Roze S, Valentine WJ, Spinas GA, Shaw JE, Zimmet PZ. Intensive lifestyle changes or metformin in patients with impaired glucose tolerance: modeling the long-term health economic implications of the diabetes prevention program in Australia, France, Germany, Switzerland, and the United Kingdom. Clin Ther. 2004 Feb;26(2):304-21. — View Citation

Pollard TM, Guell C. Assessing physical activity in Muslim women of South Asian origin. J Phys Act Health. 2012 Sep;9(7):970-6. — View Citation

Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other systolic and diastolic blood pressure common systolic and diastolic assessment of blood pressure first year
Primary glycaemia the concentration of glucose in the blood first year
Secondary Hemoglobin A1c The concentration of hemoglobin A1c in the blood shows the average level of blood sugar over the past 2 to 3 months. first year
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