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

NCT06516549 | Recruiting

• 1 other identifier: BREC000064592023
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate-vigorous Physical Activity (MVPA)

Keywords

Physical activity; Skipping rope; Informational pamphlet; Young adolescents; Community; South Africa

Outcome Measures

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.

  Baseline and follow up at 12 months after baseline

Secondary Outcomes (2)

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

  Baseline and follow up at 12 months after baseline

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

  Baseline and follow up at 12 months after baseline

Other Outcomes (1)

• Utilization of rope, process outcome

  At the 12-month follow up assessment after baseline

Study Arms (2)

Skipping rope and informational pamphlet

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Skipping rope and informational pamphlet 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.

Skipping rope and informational pamphlet

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of KwaZulu: lead
• Harvard School of Public Health (HSPH): collaborator
• Africa Academy for Public Health: collaborator
• Heidelberg University: collaborator
• Technical University of Munich: collaborator
• USINGA Health and Demographic Surveillance System: collaborator

Study Sites (1)

University of KwaZulu-Natal

Durban, KwaZulu-Natal, 4091, South Africa

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jabulani Ncayiyana, Ph.D.

CONTACT

+27 (031) 260 4459; ncayiyanaj@ukzn.ac.za

Elisabetta Ferrero, MPH

CONTACT

eferrero@hsph.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The analyst, or outcome assessor, will be masked in this clinical trial and will not know allocation status until analysis is complete.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer/Epidemiologist

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 24, 2024
• Study Start: October 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

ZA (1)