Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Lifestyle Education Programs on Diabetes Control in Rwanda (LIDI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02032108
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : January 9, 2014
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Etienne Amendezo, Kigali University Teaching Hospital

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: lifestyle counselling Not Applicable

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Lifestyle Education Programs on Diabetes Control Among Diabetic Patients at Kigali University Teaching Hospital Rwanda
Study Start Date : March 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
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.

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.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032108


Locations
Layout table for location information
Rwanda
Kigali University Teaching Hospital
Kigali, Rwanda, 655
Sponsors and Collaborators
Kigali University Teaching Hospital
Sanofi
Investigators
Layout table for investigator information
Study Chair: Charlotte M. Bavuma, Dr Kigali University Teaching Hospital
Principal Investigator: Etienne Amendezo, Dr Kigali University Teaching Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Etienne Amendezo, Dr, Kigali University Teaching Hospital
ClinicalTrials.gov Identifier: NCT02032108     History of Changes
Other Study ID Numbers: LID
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014
Keywords provided by Etienne Amendezo, Kigali University Teaching Hospital:
Diabetes lifestyle intervention Rwanda
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases