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.: PACTR201604001470619 Date of Approval: 14/02/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Physical activity and fitness promoting programmes for adolescent girls
Official scientific title Movement programme to enhance physical fitness and motor competence in girls living in low-income areas of Cape Town: A controlled clinical trial
Brief summary describing the background and objectives of the trial Several studies have reported on the high prevalence of overweight among the South African youth, yet fewer studies have focused on how to improve fitness in the female adolescent population, who carry a greater risk of developing chronic diseases in future. Therefore the present study seeks to establish the prevalence of overweight, levels of physical activity and fitness, prevalence of motor coordination problems, and to examine how these factors interact in female learners in low-income urban areas of Cape Town. The study will also determine the efficacy of interventions aimed at improving motor performance, increasing fitness levels and reducing BMI in overweight, adolescent girls.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) FAST TRIAL
Disease(s) or condition(s) being studied ,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 25/04/2016
Actual trial start date 09/05/2016
Anticipated date of last follow up 26/09/2016
Actual Last follow-up date 30/09/2016
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 72
Recruitment status Closed to recruitment,follow-up continuing
Publication URL Not applicable
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using balloting Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Neuromotor task training 2 times/week 1 hour Task based activities designed to increase strength and conditioning 36 Active-Treatment of Control Group
Control Group Wii training 2 times/week 1 hour video games focused on skills and conditioning 36 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Female learners aged 13-16 years old 2. Female learners with low levels of physical activity (less than 5000 steps per day) 2. Female learners with poor motor coordination (<16 cut off on Movement ABC-2) 1. Female learners with medical conditions (such as fractures, cerebral palsy and hemiplegia) which will hinder their participation in the study protocol will be excluded. 13 Year(s) 16 Year(s) Female
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 18/03/2016 Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Old Main Building of Groote Schuur Hospital, Floor E52, Room 23, Observatory, 7925. Cape Town 7925 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
No Health Research Ethics Committee, Medicine & Health Sciences, Stellenbosch University
Ethics Committee Address
Street address City Postal code Country
5th Floor, Teaching Building Francie van Zijlrylaan Parow Cape Town 7500 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cardiorespiratory fitness Pre-intervention (Baseline) Post interevention Follow-up (6 months after training)
Secondary Outcome physical activity, motor coordination, self-efficacy, lung function, enjoyment of physical activity Pre-intervention (Baseline) Post-intervention Follow up (6 months after training)
Secondary Outcome physical activity, motor coordination, self-efficacy, enjoyment of physical activity Pre-intervention (Baseline) Post-intervention Follow up (6 months after training)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Center of Science and Technology, Khayelitsha, Cape Town 50 Sinqolamthi Street, ILitha Park Cape Town 7784 South Africa
Bulumko Secondary School 2121 Monge21 Street 21 Cape Town 7700 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
USHEPiA N/A N/A N/A
University of Ghana LEGON ACCRA P.O.BOX LG 25 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor University of Ghana LEGON ACCRA P.O.BOX LG 25 South Africa University
Primary Sponsor International Academic Programmes Office UCT International Academic Programmes Office, Level 3 Masingene Building, Cross Campus Road, UCT Middle Campus, Rondebosch 7700, South Africa Cape Town 7700 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Gillian Ferguson Division of Physiotherapy Department of Health & Rehabilitation Sciences Suite F-45, Room 78 Old Main Building Groote Schuur Hospital Cape Town 7925 South Africa
DR. Theresa Burgess Division of Physiotherapy, Department of Health & Rehabilitation Suite F-45, Room 78 Old Main Building Groote Schuur Hospital Cape Town 7925 South Africa
Prof. Bouwien Smits-Engelsman Division of Physiotherapy, Department of Health & Rehabilitation Suite F-45, Room 78 Old Main Building Groote Schuur Hospital Cape Town 7925 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator GILLIAN FERGUSON gillian.ferguson@uct.ac.za 27 (0)21 406 6045 Division of Physiotherapy Department of Health & Rehabilitation Sciences Suite F-45, Room 78 Old Main Building Groote Schuur Hospital
City Postal code Country Position/Affiliation
CAPE TOWN 7925 South Africa Senior Lecturer/UCT
Role Name Email Phone Street address
Public Enquiries EMMANUEL BONNEY bnnemm002@myuct.ac.za 0027797356943 Division of Physiotherapy Department of Health & Rehabilitation Sciences Suite F-45, Room 78 Old Main Building Groote Schuur Hospital
City Postal code Country Position/Affiliation
CAPE TOWN 7925 South Africa Student/UCT
Role Name Email Phone Street address
Scientific Enquiries Gillian FERGUSON gillian.ferguson@uct.ac.za 27 (0)21 406 6045 Division of Physiotherapy Department of Health & Rehabilitation Sciences Suite F-45, Room 78 Old Main Building Groote Schuur Hospital
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Senior Lecturer/UCT
REPORTING
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