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

January 8, 2014 updated by: Etienne Amendezo, Kigali University Teaching Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Rwanda
      • Kigali, Rwanda, 655
        • Kigali University Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kigali University Teaching Hospital

Collaborators

Sanofi

Investigators

  • Study Chair: Charlotte M. Bavuma, Dr, Kigali University Teaching Hospital
  • Principal Investigator: Etienne Amendezo, Dr, Kigali University Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 8, 2014

First Posted (Estimate)

January 9, 2014

Study Record Updates

Last Update Posted (Estimate)

January 9, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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