Improving Lifejacket Wear Among Boaters on Lake Albert, Uganda

NCT05337761 | Unknown

• 1 other identifier: SS992ES
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

Brief Summary

A cluster randomized trial will be conducted for six months. To avoid covariate imbalance at baseline, stratified permuted block randomization with a 1:1 allocation ratio will be done. At least 387 boaters across 7 clusters per arm will be interviewed post baseline to give a 90% power to detect the effect of the intervention if such effect exists. A mixed effects multi-level modeling at 5% alpha level will be done using logical model building procedures

Conditions

Drowning

Keywords

Drowning prevention; Occupational boating; Uganda

Outcome Measures

Primary Outcomes (1)

• Change in prevalence of lifejacket wear among the boaters

  The intention to treat analysis will be used to assess the change in prevalence of lifejacket wear among the boaters. Multilevel modeling (cluster level model and boater level model) with a focus on the individual as the unit of analysis while accounting for clustering will be conducted. The generalized estimating equation (GEE) will be used to account for within-cluster variations. The goodness of fit of the model will be tested using the Hosmer Lemeshow test. Comparison between the baseline and end-line will be done and the difference in differences (Diff in Diff) will be reported to show the change of effect in the intervention and control arm.

  Six months

Study Arms (2)

Intervention

EXPERIMENTAL

The peers will be trained to train their colleagues (fellow boaters) on proper lifejacket use. A training manual has been developed for this.

Behavioral: Peer-led training on lifejacket wear

Control

PLACEBO COMPARATOR

The Marine Police will be encouraged to continue conducting their community policing on water safety and emphasize lifejacket wear.

Behavioral: Peer-led training on lifejacket wear

Interventions

Peer-led training on lifejacket wear BEHAVIORAL

Training on proper lifejacket wear will be given to peers who will be the change agents amongst their fellow boaters

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The landing sites (clusters) should not be flooded, should not be receiving any known educational/behavior related intervention except the routine marine police messages

You may not qualify if:

• Landing sites that are inaccessible because of the bad terrain and poor security

Sponsors & Collaborators

• Makerere University: lead
• Consortium for Advanced Research Training in Africa (CARTA): collaborator

Study Sites (1)

Makerere University School of Public Health

Kampala, P.O.Box:7072, Uganda

RECRUITING

Related Publications (2)

• Bennett S, Woods T, Liyanage WM, Smith DL. A simplified general method for cluster-sample surveys of health in developing countries. World Health Stat Q. 1991;44(3):98-106.

  PMID: 1949887 RESULT

• Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.

  PMID: 21513547 RESULT

MeSH Terms

Conditions

Drowning

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Frederick Oporia, MPH

  Makerere University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederick Oporia, MPH

CONTACT

+256703857428; foporia@musph.ac.ug

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study participants will not know if they are receiving the intended intervention or not, since the control arm will also be receiving some messages
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized trial

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 20, 2022
• Study Start: April 25, 2022
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Six months from the start of the study, and will be accessible to the team until completion of PhD graduation
• Access Criteria: Data will be accessed using password protected external drives

Locations

UG (1)