Effects of Lifestyle Education Programs on Diabetes Control in Rwanda

NCT ID: NCT02032108

Last Updated: 2014-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-11-30

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.

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

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

lifestyle counselling

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Kigali University Teaching Hospital

OTHER

Sponsor Role: lead

Responsible Party

Etienne Amendezo

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charlotte M. Bavuma, Dr

Role: STUDY_CHAIR

Kigali University Teaching Hospital

Etienne Amendezo, Dr

Role: PRINCIPAL_INVESTIGATOR

Kigali University Teaching Hospital

Locations

Kigali University Teaching Hospital

Kigali, Kigali, Rwanda

Countries

Rwanda

References

Amendezo E, Walker Timothy D, Karamuka V, Robinson B, Kavabushi P, Ntirenganya C, Uwiragiye J, Mukantagwabira D, Bisimwa J, Uwintwali Marie H, Umulisa H, Niyomwungeri S, Ndayambaje B, Dusabejambo V, Bavuma C. Effects of a lifestyle education program on glycemic control among patients with diabetes at Kigali University Hospital, Rwanda: A randomized controlled trial. Diabetes Res Clin Pract. 2017 Apr;126:129-137. doi: 10.1016/j.diabres.2017.02.001. Epub 2017 Feb 10.

Reference Type: DERIVED

PMID: 28237859 (View on PubMed)

Other Identifiers

LID

Identifier Type: -

Identifier Source: org_study_id