Clinical trial NCT02032108: Effects of Lifestyle Education Programs on Diabetes Control in Rwanda
Official title: Effects of Lifestyle Education Programs on Diabetes Control Among Diabetic Patients at Kigali University Teaching Hospital Rwanda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes lifestyle intervention Rwanda
Lead sponsor: Kigali University Teaching Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2014-01-09
Enrollment: 250
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Strategies to reduce the burden of diabetes in Rwanda, like in other resource poor settings, include involving diabetic patients in their own care and targeting modifiable risk factors through adopting appropriate dietary and lifestyle habits. According to previous research carried out in developed countries, lifestyle modifications may have effect on the development of diabetes and prevention of its complications.

However, direct evidence to show whether lifestyle intervention is beneficial for diabetic patients in resources limited countries like Rwanda is an open question. Though in these countries, access to healthy diet is claimed to be the barrier of implementation of therapeutic lifestyle based initiatives, we hypothesize that knowledge gaps are more important barriers than access to healthier diets and other lifestyle habits. We therefore would like to carry out this intervention to assess the effects of lifestyle education programs on glycemic control among people with diabetes followed up at CHUK.

Detailed description: The study is a randomized controlled trial with two groups (one interventional and one control) to be followed up for 12 months. It will be carried out in Kigali University Teaching Hospital, the main referral hospital in Rwanda.

Lifestyle intervention will consist in group counselling on dietary habits (meals composition, importance and ways to reduce unhealthy foods: salty (especially because hypertension is of concern among diabetic people and blood pressure will be one of the secondary outcome measures), sugar, unsaturated fats, smoking, alcohol abuse and adapt healthier regimens including fruits \& vegetables), effects of regular physical activity, importance of adherence to medications (including taking medications as directed, regular medical follow up,etc...), diabetes complications, actions to control blood sugar and ways of coping with stress.

Education \& counselling sessions will be provided by a team of registered dietitians, nurses and counselors who will have been trained for this purpose prior to the intervention and will be taking between 45 to 60 min.

After baseline data collection, subjects in the control group will continue to receive usual care delivered by attending physicians and nutritionists at CHUK. This includes usual monthly medical follow up and individual conselling on dietary habits and lifestyle change delivered by attending physicians and/or dietitians

Eligibility criteria: Inclusion Criteria:

* diagnosis of diabetes known since three months at least,
* being currently on treatment (insulin or oral hypoglycemiants),
* able to follow up at CHUK

Exclusion Criteria:

* patients with advanced diabetic complications (advanced nephropathy \& CKD, proliferative retinopathy, recent history of myocardial infarction \& severe Heart Failure (LVEF\<35%), peripheral artery disease, stroke, severe diabetic foot disease,
* any other severe illness that may impede the patient's functional capacity,
* severe psychiatric disorders
* pregnancy

Primary outcomes:
measure: between groups difference in glycated haemoglobin (HbA1c)
timeFrame: 12 months
Secondary outcomes:
measure: endpoint versus baseline differences in glycated hemoglobin
timeFrame: 12 months
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Kigali University Teaching Hospital
Study officials:
affiliation: Kigali University Teaching Hospital
name: Charlotte M. Bavuma, Dr
role: STUDY_CHAIR
affiliation: Kigali University Teaching Hospital
name: Etienne Amendezo, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amendezo E, Walker Timothy D, Karamuka V, Robinson B, Kavabushi P, Ntirenganya C, Uwiragiye J, Mukantagwabira D, Bisimwa J, Uwintwali Marie H, Umulisa H, Niyomwungeri S, Ndayambaje B, Dusabejambo V, Bavuma C. Effects of a lifestyle education program on glycemic control among patients with diabetes at Kigali University Hospital, Rwanda: A randomized controlled trial. Diabetes Res Clin Pract. 2017 Apr;126:129-137. doi: 10.1016/j.diabres.2017.02.001. Epub 2017 Feb 10.