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.: PACTR201910535635886 Date of Approval: 03/10/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The development, implementation and evaluation of a weight loss intervention for overweight/obese primary school educators at selected schools within the Metro North District in Western Cape Province, South Africa: A randomized controlled trial.
Official scientific title The development, implementation and evaluation of a weight loss intervention for overweight/obese primary school educators at selected schools within the Metro North District in Western Cape Province, South Africa: A randomized controlled trial.
Brief summary describing the background and objectives of the trial The aim of this study was to develop, implement and evaluate a weight loss intervention for overweight/obese primary school educators at selected schools within the Metro North district in the Western Cape Province, South Africa in a randomized control trial. Phase 1: Development of the intervention Specific objectives To develop a novel weight loss intervention aimed at improving food choices and thereby reducing total energy intake and increasing physical activity levels of overweight/obese educators by: • Selecting an intervention development framework • Application of the framework for development of intervention strategies/actions/messages • Integration of behaviour theory in the intervention planning process Phase 2: Randomized controlled trial to evaluate a weight loss intervention for overweight/obese primary school educators at selected schools within the Metro North district in the Western Cape Province, South Africa. Specific objectives: • To perform baseline assessments of the descriptive, primary, secondary and process outcomes of the study • To implement the intervention and conduct follow-up assessment at 16 weeks (at completion of the intervention) of the primary, secondary and process outcomes of the study • To conduct analyses to investigate within group change over time in primary, secondary and process outcomes. • To conduct analyses to investigate whether there is a difference between the control and the intervention groups in change over time in primary, secondary and process variables. • To conduct analyses to investigate the contribution of change in beliefs to change in the primary outcome variables. Phase 3: Feasibility of a weight loss intervention for overweight/obese primary school educators at selected schools within the Metro North district in the Western Cape Province, South Africa. Specific objectives: • To investigate the perception of educators who participated in the intervention arm using semi-structured in-depth interviews
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/05/2017
Actual trial start date 01/05/2017
Anticipated date of last follow up 31/10/2019
Actual Last follow-up date 28/11/2019
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 85
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Health4LIFE 16 weeks The control group received a copy of the National Department of Health ‘Healthy Lifestyle Booklet’ available to view via the following link : http://www.health.gov.za/index.php/component/phocadownload/category/166. The control group received a copy of the intervention manual at the conclusion of the study period. 42 Active-Treatment of Control Group
Experimental Group Health4LIFE 16 weeks The participants in the intervention group received a printed weight loss manual that has been developed by the research team along with 5 mobile phone messages a week, for 16 weeks. Participants therefore received a total of 80 messages throughout the intervention period. 43
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
overweight/obese educators with a BMI ≥ 27kg/m2, employed either by the Western Cape Department of Basic Education or the school governing body at selected schools within the Metro North District, English literate, own their own personal mobile phone agree not to participate in any other weight loss interventions for the duration of the study Educators who are following a weight loss intervention at the time of data collection, women who are pregnant or trying to fall pregnant or have been pregnant less than 6 months prior to data collection, lactating women, those with orthopaedic or joint problems which will be a barrier to physical activity, those with a history of major medical problems such as heart disease (including having had a pacemaker inserted) those with recent weight loss greater than 10% in the previous 6 months . Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 30/03/2017 University of Cape Town Faculty of Health Sciences Research and Ethics committee
Ethics Committee Address
Street address City Postal code Country
Grootte Schuur Hospital Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Weight 16 weeks
Secondary Outcome BMI 16 weeks
Secondary Outcome dietary intake 16 weeks
Secondary Outcome Physical activity 16 weeks
Secondary Outcome Blood pressure 16 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hindle Road Primary School Hindle road Cape Town South Africa
Kairos Primary C/O Eland and Leiden Avenue Cape Town South Africa
Winsley Primary William Taylor laan Cape Town South Africa
Pinedene Primary Pinedene street Cape Town South Africa
Parow Oos Selbourne street Cape Town South Africa
Eversdal Primary Stepping stones Cape Town South Africa
Marconi Beam Democracy Drive Cape Town South Africa
Matroos Holy Trinity St Dominic Street Cape Town South Africa
Uitsig Uitsig avenue Cape Town South Africa
Greenlands Sky Road Cape Town South Africa
Wolraad Adam Tas Avenue Cape Town South Africa
Hauge Hauge Rylaan Cape Town South Africa
Welwitschia Welwitschia Primary Cape Town South Africa
Dr vd Ross Koeberg Lane Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Fund NRF building Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nelia Steyn Anzio road Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Fatima Hoosen Nobel way Cape Town South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marjanne Senekal marjanne.senekal@uct.ac.za 0027214066784 Anzio road
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa acting head of Human Nutrition
Role Name Email Phone Street address
Public Enquiries Fatima Hoosen hsnfat006@myuct.ac.za 0021848493607 Nobel way
City Postal code Country Position/Affiliation
Cape Town 7895 South Africa PhD candidate
Role Name Email Phone Street address
Scientific Enquiries Fatima Hoosen hsnfat006@myuct.ac.za 0027848493607 Nobel Way
City Postal code Country Position/Affiliation
Cape Town 7895 South Africa PhD Candidate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes This information will be available in an excel spreadsheet and it will be di-identified for the participants. Informed Consent Form,Study Protocol This information is required to be kept by the university for a minimum of 5 years All researchers can request this information for their own analysis, the principal investigator will decide who may access this information - the request may be sent via email.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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