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.: PACTR201609001771813 Date of Approval: 07/09/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Physical activity intervention at a primary health care clinic for optimal health: the B-Healthy project
Official scientific title Physical activity intervention at a primary health care clinic for optimal health: the B-Healthy project
Brief summary describing the background and objectives of the trial Non-communicable diseases (NCDs) are currently present in nearly 60% of the South African population. The national health survey in South Africa (2013), indicate risk factors for NCDs are increasing. The aim of the study is to determine the effect of a PA intervention on perception and knowledge of PA, HRQoL, PA levels, physical fitness, risk factors for NCDs and medication prescription in community dwelling persons. Participants (N=200) will be recruited from two primary health clinics. Participants at clinic 1 will follow a 24-weeks PA intervention, while participants at clinic 2 will receive a standard care intervention. The study will follow a two-parallel group, time-series design. The effects between interventions will be compared. Tests at baseline, 12 and 24-weeks of intervention and 3 and 6-months post intervention will be performed. Study´s findings will be used to inform government on appropriate interventions to manage NCDs in South Africa¿s public health sector.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) B Healthy
Disease(s) or condition(s) being studied risk factors for non-communicable diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 13/07/2015
Actual trial start date 31/08/2015
Anticipated date of last follow up 11/07/2016
Actual Last follow-up date 30/09/2016
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 197
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
N W U - 0 0 0 4 9 - 1 5 - A 1 Health Research Ethics Committee, NWU
N/A North West Department of Health
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
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Supervised exercise once a week 60 minutes Progressive, aerobic, resistance, balance and flexibility group training 100 Active-Treatment of Control Group
Control Group Usual care once a week variable patient information, health screening and obility 97 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Males and females with stable clinical condition. Adults between the aforementioned age range. Present at least one cardiovascular risk factor (E.g. Hypertension, cholesterol, overweight/obesity, tobacco use, lack of physical activity and diabetes). Not orthopedically impaired. Moderate to low risk for PA participation based on a PAR-Q screen. Ability to perform exercise testing and exercise intervention. Persons depending on primary health clinics for health care Pregnancy and lactation Any absolute contraindications to exercise testing Orthopedic limitations. Mental limitations Access to private health care 35 Year(s) 65 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 01/09/2015 HREC
Ethics Committee Address
Street address City Postal code Country
Hoffman Street Potchefstroom 2531 South Africa
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 07/07/2015 North West Department of Health
Ethics Committee Address
Street address City Postal code Country
3801 First Street Mahikeng 2735 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knowlegde of physical activity Baseline 12-weeks 24-weeks
Primary Outcome Knowledge of risk factors for coronary heart disease Baseline 12-weeks 24-weeks
Primary Outcome Health related quality of life Baseline 12-weeks 24-weeks
Primary Outcome habitual physical activity Baseline 12-weeks 24-weeks
Primary Outcome cardiorespiratory fitness Baseline 12-weeks 24-weeks
Primary Outcome Functional capacity Baseline 12-weeks 24-weeks
Primary Outcome NCD risk factors Baseline 12-weeks 24-weeks
Primary Outcome Medication prescription Baseline 12-weeks 24-weeks
Secondary Outcome Perception of physical activity Baseline 12-weeks 24-weeks
Secondary Outcome Perception of riks factors for coronary heart disease Baseline 12-weeks 24-weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Steve Tswete Clinic Ikageng South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
North-West University Hoffman Street Potchefstroom 2531 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor North-West University Hoffman Street Potchefstroom 2531 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Melainie Cameron Locked Bag 4, University of the Sunshine Coast Maroochydore 4558 Australia
Guillermo Oveido Hoffman Street, North-West University Potchefstroom 2531 South Africa
Stanislaw Czyz Hoffman Street, North-West University Potchefstroom 2531 South Africa
Nauris Tamulevicius University of Tampa, Florida Clearwater United States of America
Sweetness Makamu Hoffman Street, North-West University Potchefstroom 2531 South Africa
Caroline Madise Hoffman Street, North-West University Potchefstroom 2531 South Africa
Mashudu Phidza Hoffman Street, North-West University Potchefstroom 2531 South Africa
Naledi Moropane Hoffman Street, North-West University Potchefstroom 2531 South Africa
Francois Watson Hoffman Street, North-West University Potchefstroom 2531 South Africa
I-Min Lee Brigham and Women's Hospital 900 Commonwealth Avenue East, Harvard University Boston MA 02215 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sarah Moss Hanlie.moss@nwu.ac.za +27182991821 Hoffman Street, North-West University
City Postal code Country Position/Affiliation
Potchefstroom 2531 South Africa Associate Professor, Director of PhASRec, North-West University
Role Name Email Phone Street address
Public Enquiries Sarah Moss Hanlie.moss@nwu.ac.za +27182991821 Hoffman Street, North-West University
City Postal code Country Position/Affiliation
Potchefstroom 2531 South Africa Associate Professor, Director of PhASRec, North-West University
Role Name Email Phone Street address
Scientific Enquiries Sarah Moss Hanlie.moss@nwu.ac.za +27182991821 Hoffman Street, North-West University
City Postal code Country Position/Affiliation
Potchefstroom 2531 South Africa Associate Professor, Director of PhASRec, North-West University
REPORTING
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