ClinicalTrials.gg
RecruitingNCT06516549Updated Nov 22, 2024

Evaluation of Skipping Rope and Informational Pamphlet Among Adolescents in South Africa

An interventional study of Skipping rope and informational pamphlet in Moderate-vigorous Physical Activity (MVPA), sponsored by University of KwaZulu. Recruiting at 1 site in South Africa. Open to participants aged 10 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by University of KwaZulu · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Oct 2024; still recruiting 2 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
700
Allocation
Randomized
Ages
10 Years to 14 Years
Sex
All
01

Study summary

The purpose of the study is to evaluate the impact of providing a skipping rope and informational pamphlet to adolescents aged 10-14 years on their physical activity intentions and behaviors from baseline to 12-month follow-up when compared with adolescents of the same age who are not provided with any intervention. This study comprises a two-arm randomized controlled trial nested within an adolescent cohort, i.e. a 'randomized trial-within-cohort'. The intervention will include providing each participant with a skipping rope and a pamphlet with general instructions for skipping the rope and messages about the importance of physical activity. The investigators hypothesize that adolescents in a South African community who are provided with a skipping rope and an informational pamphlet on physical activity will engage in more physical activity behaviors and will report greater intentions to be physically active at a 12-month follow-up, compared to a control group of adolescents who do not receive the intervention.

Read the 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.

02

Conditions studied

  • Moderate-vigorous Physical Activity (MVPA)

Browse trials for

Keywords

  • Physical activity
  • Skipping rope
  • Informational pamphlet
  • Young adolescents
  • Community
  • South Africa
03

In context

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

This study's planned enrollment of 700 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

University of KwaZulu is the lead sponsor of 34 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ;
  • 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
700 participants (estimated)

Study arms

  • 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.

    Other: Skipping rope and informational pamphlet

  • No intervention
    Control

    The control arm will not receive provision of intervention (no skipping rope or informational pamphlet).

Interventions

  • OtherSkipping rope and informational pamphlet

    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.

06

What researchers measure

Primary outcomes

  1. Duration of moderate to vigorous physical activity (MVPA) per week

    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.

    Time frame: Baseline and follow up at 12 months after baseline

Secondary outcomes

  1. Proportion of adolescents who meet the MVPA recommendations over the 7 days preceding the interview

    Percentage of adolescents who meet the WHO MVPA recommendations of at least 60 minutes/day of MVPA across the week (\>=420 minutes/week)

    Time frame: Baseline and follow up at 12 months after baseline

  2. Intention to engage in physical activity compared to the 7 days preceding the interview

    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.

    Time frame: Baseline and follow up at 12 months after baseline

Other outcomes

  1. Utilization of rope, process outcome

    Utilization modality of skipping rope, that is alone or with friends, among intervention group

    Time frame: At the 12-month follow up assessment after baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Dec 2025, 14 months after the start.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 14 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2024
First posted
Jul 24, 2024
StartActual
Oct 1, 2024
Primary completionEst.
Dec 30, 2025
CompletionEst.
Dec 30, 2025
Last update
Nov 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06516549
Lead sponsor
University of KwaZulu
Collaborators
Harvard School of Public Health (HSPH), Africa Academy for Public Health, Heidelberg University, Technical University of Munich, USINGA Health and Demographic Surveillance System
Responsible party
Jabulani Ncayiyana (Senior Lecturer/Epidemiologist, University of KwaZulu) — Principal investigator
First posted
Jul 24, 2024
Start date
Oct 1, 2024
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Nov 22, 2024

Study contacts

Jabulani Ncayiyana, Ph.D.
Contact
ncayiyanaj@ukzn.ac.za
+27 (031) 260 4459
Elisabetta Ferrero, MPH
Contact
eferrero@hsph.harvard.edu
Jabulani Ncayiyana, Ph.D.
principal investigator · University of KwaZulu
Mosa Moshabela
principal investigator · University of KwaZulu
Mary Mwanyika-Sando
principal investigator · Africa Academy of Public Health
Michael Laxi
principal investigator · Technical University of Munich
Till Bärnighausen
principal investigator · Heidelberg University
Jacob Burns
principal investigator · Technical University of Munich

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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