Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201803002770964 Date of Approval: 15/11/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Daily Walking in Adult Patients with Type 2 Diabetes Mellitus
Official scientific title Effects of Increasing Daily Walking in Adult Patients with Type 2 Diabetes Mellitus Attending the Debre Tabor General Hospital, Northwest Ethiopia. Randomized Controlled Intervention Design
Brief summary describing the background and objectives of the trial Diabetes mellitus is major public health problems with rapidly increasing its prevalence worldwide. Regular physical activity is one of the cornerstones in the prevention and management of diabetes mellitus. This study aimed to assess the effects of increasing daily walking on glycaemic control in adult patients with type 2 diabetes mellitus attending in Debre Tabor general hospital, Northwest Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diabetes mellitus,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 14/03/2016
Actual trial start date 14/03/2016
Anticipated date of last follow up 06/06/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group physical activity prescription 10,000 steps per day 12 week period Intervention group participants were given physical activity prescription that led towards a goal of gradually increasing to at least 10,000 steps per day for the following 12 week period. 30
Control Group Normal activity The control group was asked to maintain their normal activity habits throughout the 12-weeks 12-weeks The control group was asked to maintain their normal activity habits throughout the 12-weeks intervention period 30 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Participants whose ages 18 years and above. -Participants who can walk 1.6 kilometers (1 mile) without pain and discomfort. -Patients were excluded if they are under the age of 18 years. -Individuals with orthopedic limitations for walking or with conditions such as impaired vision and foot ulcers that puts them at risk while exercising. -Individuals currently taking weight loss medications. -Individuals taking prescription medications that might impair ability to walk. - History of coronary artery disease, renal impairment, hepatic impairment, severe diabetic neuropathy or retinopathy - Pregnant women 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/12/2015 Amhara Regional Health Research Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
kebele Bahir dar Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome glycemic control week 13
Secondary Outcome Change in Anthropometric measurement, Blood pressure, and Heart rate week 13
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Debre Tabor General Hospital Kebele 2 Debre Tabor Ethiopia
Debre Tabor General Hospital Kebele 2 Debre Tabor Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
TEPHINET and CDC Decatur, GA 30030 Atlanta, Georgia United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Task Force for Global Health, Inc. TEPHINET Decatur, GA 30030 Atlanta, Georgia United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Edward Gregg GA 30341 Atlanta, Georgia United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Achenef Muche ashua2014@gmail.com +251939529888 Azezo
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia Lecturer at University of Gondar
Role Name Email Phone Street address
Public Enquiries Achenef Muche ashua2014@gmail.com +251939529888 Azezo
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia Lecturer at University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Edward Gregg ashua2014@gmail.com +251939529888 GA 30341
City Postal code Country Position/Affiliation
Atlanta United States of America Chief, Division of Diabetes Translation, Centers for Disease Control and Prevention
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information