Clinical trial NCT04281069: Diabetes Type 2 in the Eastern Region of Morocco
Official title: Diabetes Type 2 in the Eastern Region of Morocco , Towards an Evidence-based Multidisciplinary Lifestyle Approach in Diabetes Type 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Diabetes Mellitus, Type 2
Adherence, Medication
Diet Habit
Keywords: diabetes mellitus type 2
quality of life
interdisciplinary care
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Artesis Plantijn University College, Antwerp
name: Université Mohammed Premier, Oujda
name: Vliruos
First posted: 2020-02-24
Enrollment: 821
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: step 1) all women, diagnosed with diabetes or not step 2) adults diagnosed with diabetes type 2

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* women
* visiting the 35 local health centres and the CRD in Oujda
* adult
* Moroccan

Exclusion Criteria:

* male
* no informed consent

Primary outcomes:
measure: glycaemia
timeFrame: first year
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: first year
Other outcomes:
measure: systolic and diastolic blood pressure
timeFrame: first year
Locations:
city: Oujda
country: Morocco
facility: Université Mohammed Premier Oujda (UMP) Faculté des Sciences, Département de Biologie
state: Oujda Angad
Study officials:
References:
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. doi: 10.1123/jpah.9.7.970.
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. doi: 10.2337/diacare.27.5.1047.
citation: 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.
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. doi: 10.1016/s0149-2918(04)90029-x.
citation: Lindstrom J, Peltonen M, Eriksson JG, Ilanne-Parikka P, Aunola S, Keinanen-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.