NCT02032108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

8 months

First QC Date

January 8, 2014

Last Update Submit

January 8, 2014

Conditions

Diabetes Mellitus

Keywords

Diabetes lifestyle intervention Rwanda

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • endpoint versus baseline differences in glycated hemoglobin

    12 months

Study Arms (1)

lifestyle counselling

EXPERIMENTAL

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

Interventions

lifestyle counsellingBEHAVIORAL

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.

lifestyle counselling

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of diabetes known since three months at least,
  • being currently on treatment (insulin or oral hypoglycemiants),
  • able to follow up at CHUK

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kigali University Teaching Hospital

Kigali, Kigali, 655, Rwanda

Location

Related Publications (1)

  • 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.

    PMID: 28237859DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Charlotte M. Bavuma, Dr

    Kigali University Teaching Hospital

    STUDY CHAIR

  • Etienne Amendezo, Dr

    Kigali University Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 8, 2014

First Posted

January 9, 2014

Study Start

March 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

RW(1)