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.: PACTR201806003434299 Date of Approval: 31/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of high intensity intermittent exercise on body composition in South African women
Official scientific title The effect of high intensity intermittent training on body composition and cardiometabolic health in healthy and overweight or obese women: a randomised controlled trial
Brief summary describing the background and objectives of the trial Physical inactivity is one of the largest public health concerns of the 21st century. In South Africa, it is reported that 48% of the population does not meet the minimum requirements of recommended weekly activity which is a minimum of 150-minutes moderate to vigorous intensity aerobic activity. Considering the large proportion of individuals not meeting minimum activity requirements, alternative strategies to reduce the burden of disease caused by inactivity are required. Aim The aim of this study is to determine the effects high intensity intermittent training on the body composition and cardiometabolic effects of South African women. Objectives To determine the effects of a 14-week HIIT intervention program on body composition (primary outcome) and cardiometabolic health (secondary outcomes) of healthy and overweight/obese women. This study will be a randomized controlled trial.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Overweight, obesity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/07/2018
Actual trial start date
Anticipated date of last follow up 01/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
M180253 Human Research Ethics Committee University of the Witwatersrand
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 computer generated Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Healthy weight non-HIIT None 14 weeks Control will take part in their normal activities 40 Active-Treatment of Control Group
Control Group Overweight/obese non-HIIT None 14 weeks Control will take part in their normal activities 40 Active-Treatment of Control Group
Experimental Group Healthy HIIT 11 minutes 6 times per week 14 weeks HIIT exercise will be performed 40
Experimental Group Overweight/obese HIIT 11 minutes 6 times per week 14 weeks HIIT exercise will be performed 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age: 18-40 years BMI: 20 - 35kg/m2 Women only Injury or clinical diagnosis that will exclude them from taking part in exercise. BMI: less than 20 and greater than 35 kg/m2. Known or treated hypertension, diabetes or cardiovascular disease. Age: less than 18 or over 40 years. Men Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 40 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 02/05/2018 Human Research Ethics Committee (Medical) University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
7 York Road, Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in body composition Baseline: before starting the intervention 4 weeks after the start of the intervention. 8 weeks after the start of the intervention At the end of the intervention (14 weeks)
Secondary Outcome Changes in cardiometabolic health Before and after the 14 week intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Movement Physiology Research Laboratory 7 York Road, Parktown Johannesburg 2193 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Movement Physiology Research Laboratory 7 York Road, Parktown Johannesburg 2193 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rebecca Meiring 7 York Road, Parktown Johannesburg 2193 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Janine Donaldson 7 York Road, Parktown Johannesburg 2193 South Africa
Samantha Kerr 7 York Road, Parktown Johannesburg 2193 South Africa
Chloe Dafkin 7 York Road, Parktown Johannesburg 2193 South Africa
Aletta Millen 7 York Road, Parktown Johannesburg 2193 South Africa
Vernice Peterson 7 York Road, Parktown Johannesburg 2193 South Africa
Estelle Watson Wits Education Campus, St Andrews Road, Parktown Johannesburg 2193 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rebecca Meiring Rebecca.Meiring@wits.ac.za 0763112725 7 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Estelle Watson Estelle.Watson@wits.ac.za +27117173227 Impilo building, Wits Education Campus, 27 St Andrews Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Rebecca Meiring Rebecca.Meiring@wits.ac.za 0763112725 Wits Medical School, 7 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Senior Lecturer
REPORTING
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