Diabetes Mellitus Clinical Trial
Official title:
Effects of Lifestyle Education Programs on Diabetes Control Among Diabetic Patients at Kigali University Teaching Hospital Rwanda
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.
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
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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