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.: PACTR202008639923938 Date of Approval: 20/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Physical activity and nutrition education in overweight and obese adolescents
Official scientific title Effect of physical activity and nutrition education on BMI, blood pressure and selected biochemical variables in overweight and obese adolescents
Brief summary describing the background and objectives of the trial The prevalence of obesity among adults and children in both developed and developing countries has reached epidemic proportions (Bhadoria et al., 2015; Ngwenya & Ramukumba, 2017). According to the World Health Organization, the majority of the overweight and obese children live in developing countries with adolescents from developed and developing countries now affected by the obesity pandemic in a similar pattern ((WHO, 2017a) ). An increase in overweight and obesity is linked to fatty liver disease, sleep apnea, Type 2 diabetes, asthma, hypertension, cardiovascular disease, high cholesterol, glucose intolerance and insulin resistance, menstrual abnormalities, impaired balance, and orthopedic problems (Hassink, 2018). Although most of the physical health conditions associated with childhood obesity are preventable and can disappear when a child or adolescent reaches a healthy weight, some continue to have negative consequences throughout adulthood (Hassink, 2018). The most successful interventions to treat overweight and obese children younger than 18 years of age are multidimensional, considering diet and physical activity in school and community settings (Bushaw, 2019). Despite the benefits of dietary and or physical activity interventions on anthropometrical, selected physiological and biochemical parameters in overweight and obese adolescents in high-income countries, there is minimal evidence for interventions aimed at obese and overweight adolescent children from low-to-middle income countries like South Africa. To address the critical gap that will enable effective management of overweight and obese adolescents globally; the study aimed to determine the effect of a combined physical activity (PA) and nutrition education intervention program (PAN) on body mass index (BMI), blood pressure and selected biochemical variables in overweight and obese South African adolescents from the KwaZulu-Natal area.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obesity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 28/01/2019
Actual trial start date 11/02/2019
Anticipated date of last follow up 20/11/2019
Actual Last follow-up date 30/01/2020
Anticipated target sample size (number of participants) 900
Actual target sample size (number of participants) 41
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 Non-randomised 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 No intervention Continued with normal activities of daily living 10 weeks Participants continued with normal activities of daily living 19 Uncontrolled
Experimental Group Physical activity and nutrition education intervention group A combined aerobic and resistance training program supervised twice a week for 50 minutes, a nutrition intervention once a week for one hour, and participants performed unsupervised aerobic exercise three times a week for 30 minutes. 10 weeks PA intervention Following the ACSMs guidelines (Riebe et al., 2015), participants attended group classes, presented by a biokineticist twice a week during an extracurricular time slot. The interventions consisted of 20 (2 days per week for ten weeks) exercise sessions. The intervention aimed at attaining an exercise intensity of between 60%-80% of the participant’s heart rate reserve (HRR). The corresponding RPE scale is a score of between 14-16 out of 20 (Riebe et al., 2015). Each session began with five minutes of warm-up (stretching and flexibility), followed by 10 minutes of resistance training, 20 minutes of aerobic training and five minutes of cool down. The exercise program was split into three phases, each consisting of five different exercises for each phase, to ensure metabolic adaptations. Participants followed an individualised progressive resistance training program: Phase I (week 1-4), three sets of 30-second durations of five exercises at an RPE of 14-15; Phase II (week 5-7) three sets of 30-second durations of five exercises (RPE 15-16); Phase III (week 8-10) three sets of 30-second durations of five exercises (RPE 16-17) using the participant’s body weight as the primary form of resistance to encourage home-based exercising. Nutrition education program A registered dietitian individually discussed information surrounding food consumption habits with each participant and highlighted specific issues such as excessive fat and/or sugar consumption and/or under consumption of fruit and vegetables. The participants then attended a weekly culturally sensitive interactive nutrition curriculum for one hour over 10-weeks, designed to encourage weight loss. The emphasis of the nutrition intervention was on healthy eating and a non-diet approach. The South African Food Based Dietary guidelines were used as the basis to improve the nutritional content of their diet (Vorster et al., 2013). 22
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Grade 8 and 9 learners. Eligible participants were identified by measuring their height and weight to calculate BMI. Boys and girls with a BMI ≥ 85th percentile were approached for inclusion in the intervention study. Not able to attend the intervention Grade 10 and older learners BMI < 85th percentile Adolescent: 13 Year-18 Year 13 Year(s) 17 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 18/10/2018 Univerisy of KwaZulu Natal Biomedical research ethics committee
Ethics Committee Address
Street address City Postal code Country
University road, UKZN Westville campus Durban 3629 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Effect of a combined physical activity (PA) and nutrition education intervention program (PAN) on body mass index (BMI), blood pressure and selected biochemical variables in overweight and obese South African adolescents Pre and post intervnetion
Secondary Outcome None N/A
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
JEANNE GRACE 12 Victoria Park Durban 3629 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Medical research council Francie Van Zijl Drive, Parow Valley, Cape Town Cape Town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor JEANNE GRACE 12 Victoria Park Durban 3629 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Sarah J Moss University road, North-West University, Potchefstroom Potchefstroom 2520 South Africa
Chara Biggs University road, University of Kwazulu Natal, Pietermaritzburg campus, Pietermaritzburg Pietermaritzburg 3200 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Patricia Ngwenya Ngwenyap@ukzn.ac.za +27312608431 University road, UKZN Westville campus, Westville, Durban
City Postal code Country Position/Affiliation
Durban 3629 South Africa UKZN Grants coordinator
Role Name Email Phone Street address
Scientific Enquiries Anusha Marimuthu marimuthu@ukzn.ac.za +27312604769 University road, UKZN Westville campus, Westville, Durban
City Postal code Country Position/Affiliation
Durban 3629 South Africa Senior admin officer UKZN Biomedical research office
Role Name Email Phone Street address
Principal Investigator Jeanne Grace Gracej@ukzn.ac.za 27832331523 University road, UKZN Westville campus, Westville, Durban
City Postal code Country Position/Affiliation
Durban 3629 South Africa Principal investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will be made available on request by emailing the principal investigator, Jeanne Grace, on Gracej@ukzn.ac.za. Informed Consent Form,Statistical Analysis Plan,Study Protocol Requested documents will be made available upon request. Data that will conflict the information provided in manuscripts submitted for publication will not be made available. Conflicting data will only made available once the manuscripts are accepted for publication. The study protocol and informed consent is immediately available on request. Open access of data will be allowed considering IPD sharing time frame statement above. The principal investigator will decide the type of data that can be made available.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not available yet Yes 20/08/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 20/08/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information