Fluid at Work Study | NCT05260840

Studies
Fluid at Work Study

NCT05260840

Sponsor

King's College London

Status

Completed

Last Update Posted

Jan 25, 2023Actual

Enrollment

71Actual

Phase

Not provided

Conditions

Healthy

Interventions

Evaluation study - provision of an online questionnaire

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2022Actual

Primary Completion Date

Jan 20, 2023Actual

Completion Date

Jan 20, 2023Actual

First Submitted Date

Feb 18, 2022

First Submission Date that Met QC Criteria

Feb 18, 2022

First Posted Date

Mar 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2023

Last Update Posted Date

Jan 25, 2023Actual

Name	Class
British Dietetic Association	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the Fluid at Work Study is to develop and evaluate a fluid intake measurement tool for use in the UK working population.

From the results of a systematic review and a round table discussion a novel fluid measurement tool has been developed - the Workplace Beverage Intake Questionnaire (WBIQ)

The observational evaluation study will measure the relative validity and reliability of WBIQ for assessing fluid intake in a workplace population.

Detailed Description

The aim of the Fluid at Work Study is to develop and evaluate a fluid intake measurement tool for use in the UK working population.

From the results of a systematic review and a round table discussion a novel fluid measurement tool has been developed - the Workplace Beverage Intake Questionnaire (WBIQ)

WBIQ will be used to conduct a preliminary investigation of relative validity and reliability. Relative validity of the tool will be tested, rather than 'absolute validity', as there is no 'gold' standard measure for exact fluid intake in free living population groups.

Individuals responding to local advertisements will complete an initial telephone or email questionnaire, and then eligible respondents will be asked to attend King's College London for a screening visit where they will be asked questions to confirm their inclusion criteria. Inclusion criteria: full-time disked based/ office workers. Following confirmation of eligibility and written consent participants will be asked to attend two study visits 7-days apart and complete three on-line fluid intake surveys.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Evaluation study - provision of an online questionnaire	Other	Evaluation study - provision of an online questionnaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relative validity of fluid intake measurement	Measured against 24-hr urine output, specific gravity and 7 day reported fluid intake	7 days
Reliability of fluid intake measurement (l/day)	Comparison of WBIQ responses at 3 time points	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Full-time employee working in a desk-based role
No history of heart attack, stroke, angina, thrombosis, liver or kidney diseases, diabetes, chronic gastrointestinal disorder, or cancer
Able to remain within the UK during the 8-10-week period of testing
No history of excess alcohol intake or substance abuse
Agree to not drink alcohol for the 7-day period of dietary data collection
Not already participating in a clinical trial
Not currently taking medication that is likely to alter kidney function or fluid balance
Able to understand the information sheet and willing to comply with study protocol
Able to give informed written consent

Exclusion Criteria:

Pregnant or breast feeding

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Desk based office employees

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Life Course Sciences		London		SE1 9NH	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided