Effects of Lifestyle Education Programs on Diabetes Control in Rwanda

Overview

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.

Full Title of Study: “Effects of Lifestyle Education Programs on Diabetes Control Among Diabetic Patients at Kigali University Teaching Hospital Rwanda”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2013

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

Interventions

  • Behavioral: lifestyle counselling
    • A 45-min lifestyle educational session will be delivered to the subjects randomized to the intervention group every month for one year. Lifestyle intervention will consist in group counselling on dietary habits, effects of regular physical activity, importance of adherence to medications, diabetes complications, actions to control blood sugar and ways of coping with stress.

Arms, Groups and Cohorts

  • Experimental: lifestyle counselling
    • A 45-min lifestyle educational session will be delivered to the subjects randomized to the intervention group every month for one year. Lifestyle intervention will consist in group counselling on dietary habits, effects of regular physical activity, importance of adherence to medications, diabetes complications, actions to control blood sugar and ways of coping with stress.

Clinical Trial Outcome Measures

Primary Measures

  • between groups difference in glycated haemoglobin (HbA1c)
    • Time Frame: 12 months
    • At the end of 12 months follow up, the mean (or median) differences in glycated hemoglobin of the interventional group and the control group will be analysed.

Secondary Measures

  • endpoint versus baseline differences in glycated hemoglobin
    • Time Frame: 12 months
    • at the end of 12 months follow up, endpoint versus baseline differences in the overall study population glycated hemoglobin levels will be analyzed.

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 21 Years

    Maximum Age: 75 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Kigali University Teaching Hospital
    • Collaborator
      • Sanofi
    • Provider of Information About this Clinical Study
      • Principal Investigator: Etienne Amendezo, Dr – Kigali University Teaching Hospital
    • Overall Official(s)
      • Charlotte M. Bavuma, Dr, Study Chair, Kigali University Teaching Hospital
      • Etienne Amendezo, Dr, Principal Investigator, Kigali University Teaching Hospital

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.