Effects of Lifestyle Education Programs on Diabetes Control in Rwanda

Diabetes Mellitus Clinical Trial

— LIDI  

Official title:

Effects of Lifestyle Education Programs on Diabetes Control Among Diabetic Patients at Kigali University Teaching Hospital Rwanda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032108
• Other study ID #: LID
• Status: Completed
• Phase: N/A
• First received: January 8, 2014
• Last updated: January 8, 2014
• Start date: March 2013
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Kigali University Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Rwanda: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Rwanda	Kigali University Teaching Hospital	Kigali

Sponsors (2)

Lead Sponsor	Collaborator
Kigali University Teaching Hospital	Sanofi

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	between groups difference in glycated haemoglobin (HbA1c)	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.	12 months	No
Secondary	endpoint versus baseline differences in glycated hemoglobin	at the end of 12 months follow up, endpoint versus baseline differences in the overall study population glycated hemoglobin levels will be analyzed.	12 months	No