NCT03982056

Brief Summary

The study involves measurements of body composition using a DEXA scanner, lung function, buoyancy and floating technique. An understanding of the effects of physiological and anthropometric measures on an individual's ability to float may lead to the creation of a 'Floatability Score' to aid current public information. With this floatability score a set of actions that people of certain body types should adopt in water will be created, to tailor the current public safety messaging in an attempt to ensure more people are aware of how they can float in water

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

June 13, 2019

Status Verified

June 1, 2019

Enrollment Period

1 year

First QC Date

June 10, 2019

Last Update Submit

June 11, 2019

Conditions

Keywords

FloatingScullingwater safety

Outcome Measures

Primary Outcomes (1)

  • Floating index

    Describes the actions required to stay afloat

    2 minutes

Secondary Outcomes (6)

  • Standing Height

    with the two week study window

  • Mass

    with the two week study window - performed at the same time of day as the floating and DEXA scan measurements

  • Body composition

    with the two week study window - performed at the same time of day as the floating and DEXA scan measurements

  • Lung function

    with the two week study window - performed at the same time of day as the floating and DEXA scan measurements

  • Buoyancy

    with the two week study window - performed at the same time of day as the floating and DEXA scan measurements

  • +1 more secondary outcomes

Study Arms (2)

Main study group

Assessments performed: * Height * Mass * Body fat density * Bone density * Lean muscle density * Lung volume measurements * Floating technique * Buoyancy

Other: this is an observational study there are no interventions

Validation group

Assessments performed: * Height * Mass * Body fat density * Bone density * Lean muscle density * Lung volume measurements * Floating technique * Buoyancy

Other: this is an observational study there are no interventions

Interventions

development of an index to provide appropriate information on a person's ability to float, based on Physiological and anthropometric characteristics

Main study groupValidation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Accepting all adults able to give their own consent to participate, the investigators aim to recruit a mixture of participants of different body size, shape, sex and race

You may qualify if:

  • All participants who feel confident in water which they can stand up in, aged 18 years and older (18-29 years for Phase 1).
  • The participant is willing and able to give informed consent for participation in the study.
  • Be able to climb up and down a set of steps to access the swimming flume

You may not qualify if:

  • Have allergies to water or chlorinated water.
  • The participant is pregnant or suspects they may be pregnant.
  • Not able to climb up and down a set of steps to access the swimming flume

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heather Massey

Portsmouth, Hampshire, PO1 2ER, United Kingdom

Location

Study Officials

  • Heather Massey, PhD

    University of Portsmouth

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Massey, PhD

CONTACT

Ant Shepherd, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

June 10, 2019

First Posted

June 11, 2019

Study Start

July 1, 2019

Primary Completion

June 30, 2020

Study Completion

December 30, 2020

Last Updated

June 13, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

The participant's data will be anonymized and presented to interested parties as part of the groups' data. There are no plans to share the information which can be identifiable to a particular participant.

Locations