- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06516549
Evaluation of Skipping Rope and Informational Pamphlet Among Adolescents in South Africa
Impact of Skipping Rope and Informational Pamphlet on Physical Activity Among Adolescents in South Africa
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adolescence is a key period of life during which important physical and psychosocial changes happen. With adolescents comprising about 16% of the world population and 23% of the population in Sub-Saharan Africa (SSA), it is critical to address their health needs to ensure their present wellbeing, as well as healthier trajectories across the life course. One of the most important aspects of a healthy lifestyle during adolescence is physical activity. Regular physical activity improves several physical and mental health outcomes among adolescents. This includes improving muscular strength and flexibility, bone mass, cardiovascular health, lung function, and reducing the risk of obesity and related diseases, such as type 2 diabetes or heart diseases. Additionally, physical activity can improve energy levels, mood, sleep, academic attainment, and social behavior, and it provides an opportunity to connect with peers, by reducing feelings of isolation and fostering friendships.
The World Health Organization (WHO) recommends that adolescents do at least 60 minutes of moderate-to-vigorous physical activity (MVPA) per day, incorporating vigorous-intensity aerobic activities at least three days a week, and limiting the amount of time spent being sedentary. Despite this, research found that adolescents in SSA tend to be largely inactive, with about 82-90% of adolescents reporting low physical activity levels. Similarly, studies suggest that a large proportion of adolescents in South Africa does not meet the physical activity recommendations, with about 93% of males and 95% of females reporting a decrease in physical activity outside of school or sports clubs over adolescence, compared to childhood, and with only 50% of children and adolescents meeting the recommended one hour of MVPA per day.
Skipping, or jumping rope, is a type of physical activity practiced among adolescents across the world. It requires a simple rope and involves the simultaneous rotation of arms and vertical jumping. Skipping rope is an ideal way to promote physical activity among adolescents in South Africa, as it is an easy-to-implement, whole body exercise that has been associated with increased cardiorespiratory fitness and improved bone density. Providing education on the importance of physical activity and instructions on how to skip rope, in addition to the rope itself, can help increase awareness about the benefits of being active and skipping rope, and can help adolescents develop physical activity skills. While there is substantial evidence for short-term positive effects of skipping rope and of successful implementation in schools, there is limited evidence on long-term effects and on implementation in community settings outside of school. Additionally, to the investigators' knowledge, there is limited evidence on skipping rope interventions for adolescents in South Africa.
To address these gaps, the investigators propose to implement a parallel arm randomized controlled trial (1:1 allocation) to promote physical activity among adolescents aged 10-14 years in a community setting in South Africa. This trial will focus on the provision of a skipping rope and informational pamphlet on physical activity and examine their impact on measures of physical activity intentions and behaviors among adolescents over 12 months from baseline. The trial, described in this protocol, will be nested within the Design and Evaluation of Adolescent Health Interventions and Policies (DASH) project, aimed at boosting adolescent health in the SSA region through rigorous population-based intervention and policy research. The DASH project involves the establishment of a cohort of adolescents and young adults, who will be followed up over four waves of data collection in four years. The trial is not invasive.
For the intervention group, the provision of rope and informational pamphlet will happen during the participant interview within the overall DASH cohort study. The fieldworker conducting the survey interview will provide each participant in the intervention group with a rope and pamphlet and will read a short script explaining how to use the rope, outlining the benefits of physical activity for adolescents, and asking participants to read the pamphlet in their own time. The control group will not receive any intervention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jabulani Ncayiyana, Ph.D.
- Phone Number: +27 (031) 260 4459
- Email: ncayiyanaj@ukzn.ac.za
Study Contact Backup
- Name: Elisabetta Ferrero, MPH
- Email: eferrero@hsph.harvard.edu
Study Locations
-
-
KwaZulu-Natal
-
Durban, KwaZulu-Natal, South Africa, 4091
- Recruiting
- University of KwaZulu-Natal
-
Contact:
- Jabulani Ncayiyana, Ph.D
- Phone Number: +27 031-260-4459
- Email: NcayiyanaJ@ukzn.ac.za
-
Contact:
- Jabulani Ncayiyana, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Study participant is between ages 10 and 14 years;
- Minors (i.e. less than 18 years of age): the parents or guardians provide written informed consent;
- Minors: the minor participant provides informed assent;
- Study participant is a resident of the study area and intends to stay in the study area for the duration of the study;
Exclusion Criteria:
- Participants with physical disabilities that prevent them from doing physical activity will be excluded;
- Those participants whose capacity to make meaningful decisions is in question because they are "cognitively impaired" will be excluded;
- Individuals with communication difficulties will be excluded.
- Study participants who report suicidal behaviors during baseline data collection will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Skipping rope and informational pamphlet
The intervention group will be provided with a skipping rope and pamphlet with information on the importance of physical activity and ways to engage in physical activity.
Both the skipping rope and pamphlet will be provided only once after completing the baseline interview.
|
The provision of a skipping rope and an informational pamphlet to the intervention arm participants will happen during the participant interview within the overall DASH cohort study.
The enumerator conducting the survey interview will provide each participant in the intervention group with a skipping rope and pamphlet and will read a short script explaining how to use the rope, outlining the main benefits of physical activity for adolescents, and asking participants to read the pamphlet in their own time.
|
|
No Intervention: Control
The control arm will not receive provision of intervention (no skipping rope or informational pamphlet).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of moderate to vigorous physical activity (MVPA) per week
Time Frame: Baseline and follow up at 12 months after baseline
|
Total minutes of MVPA/week.
This will be calculated by multiplying the minutes of MVPA on the most recent day participant did MVPA by the number of days MVPA was done.
|
Baseline and follow up at 12 months after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of adolescents who meet the MVPA recommendations over the 7 days preceding the interview
Time Frame: Baseline and follow up at 12 months after baseline
|
Percentage of adolescents who meet the WHO MVPA recommendations of at least 60 minutes/day of MVPA across the week (>=420 minutes/week)
|
Baseline and follow up at 12 months after baseline
|
|
Intention to engage in physical activity compared to the 7 days preceding the interview
Time Frame: Baseline and follow up at 12 months after baseline
|
Intention to engage in physical activity compared to previous 7 days.
This will be evaluated by asking participants if they intend to change the amount of physical activity they do in the 7 days following the interview, compared to the 7 days preceding the interview.
|
Baseline and follow up at 12 months after baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Utilization of rope, process outcome
Time Frame: At the 12-month follow up assessment after baseline
|
Utilization modality of skipping rope, that is alone or with friends, among intervention group
|
At the 12-month follow up assessment after baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jabulani Ncayiyana, Ph.D., University of KwaZulu
- Principal Investigator: Mosa Moshabela, University of KwaZulu
- Principal Investigator: Mary Mwanyika-Sando, Africa Academy of Public Health
- Principal Investigator: Michael Laxi, Technical University of Munich
- Principal Investigator: Till Bärnighausen, Heidelberg University
- Principal Investigator: Jacob Burns, Technical University of Munich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BREC000064592023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
It is not yet known if there will be a plan to make IPD available. There are ethical concerns about data privacy and confidentiality that require careful consideration before sharing individual-level data as the trial is embedded with the large DASH Project.
A detailed statistical plan will be developed in due course and made available on this registry.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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