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

NCT ID: NCT06516549

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-12-30

Brief 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.

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.

Conditions

Moderate-vigorous Physical Activity (MVPA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Skipping rope and informational pamphlet

Intervention Type: OTHER

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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Skipping 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: collaborator

Africa Academy for Public Health

OTHER

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: collaborator

USINGA Health and Demographic Surveillance System

UNKNOWN

Sponsor Role: collaborator

University of KwaZulu

OTHER

Sponsor Role: lead

Responsible Party

Jabulani Ncayiyana

Senior Lecturer/Epidemiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jabulani Ncayiyana, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of KwaZulu

Mosa Moshabela

Role: PRINCIPAL_INVESTIGATOR

University of KwaZulu

Mary Mwanyika-Sando

Role: PRINCIPAL_INVESTIGATOR

Africa Academy of Public Health

Michael Laxi

Role: PRINCIPAL_INVESTIGATOR

Technical University of Munich

Till Bärnighausen

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Jacob Burns

Role: PRINCIPAL_INVESTIGATOR

Technical University of Munich

Locations

University of KwaZulu-Natal

Durban, KwaZulu-Natal, South Africa

Site Status: RECRUITING

Countries

South Africa

Central Contacts

Jabulani Ncayiyana, Ph.D.

Role: CONTACT

ncayiyanaj@ukzn.ac.za

+27 (031) 260 4459

Elisabetta Ferrero, MPH

Role: CONTACT

eferrero@hsph.harvard.edu

Facility Contacts

Jabulani Ncayiyana, Ph.D

Role: primary

NcayiyanaJ@ukzn.ac.za

031-260-4459 ext. +27

Jabulani Ncayiyana, Ph.D.

Role: backup

Other Identifiers

BREC000064592023

Identifier Type: -

Identifier Source: org_study_id