NCT02330809

Brief Summary

The purpose of this study is to find out if drinking extra water helps people prevent or relieve headaches and hunger and, if so, what volume of water is most effective and when is it best to drink it?

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 30, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 5, 2015

Completed
4.1 years until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

December 30, 2014

Last Update Submit

March 18, 2021

Conditions

Headache

Keywords

headachehunger intensitypublic led online trialwater intake

Outcome Measures

Primary Outcomes (1)

  • Reduction of headache frequency/intensity

    Online participant reported visual analog scales

    Daily for 14 days

Secondary Outcomes (4)

  • Hunger

    Daily for 14 days

  • Mood Questionnaire

    Daily for 14 days

  • Body mass index (BMI)

    Baseline and day 14

  • Wellbeing

    Baseline and day 14

Study Arms (4)

Daily extra water intake 2L

EXPERIMENTAL

Timing of daily extra water intake intervention-A: extra water intake: 8 8oz glasses of water a day (2L) - 2 first thing in the morning before breakfast, 2 before midday or midday meal, 2 before afternoon meal and 2 before evening meal. Intervention-B: Drink extra water at anytime over 24 hours

Other: Daily extra water intakeOther: Timing of daily extra water intake

Daily extra water intake 1L

EXPERIMENTAL

Timing of daily extra water intake Intervention-A: 4 8oz glasses of water a day (1L) - 1 first thing in the morning before breakfast, 1 before midday or midday meal, 1 before afternoon meal and 1 before evening meal. Intervention-B: Drink extra water at anytime over 24 hours

Other: Daily extra water intakeOther: Timing of daily extra water intake

Daily extra water intake 500ml

EXPERIMENTAL

Timing of daily extra water intake Intervention-A: 2 8oz glasses of water a day (500ml) - each half an hour before a meals Intervention-B: Drink extra water at anytime over 24 hours

Other: Daily extra water intakeOther: Timing of daily extra water intake

Daily extra water intake 120ml

EXPERIMENTAL

Timing of daily extra water intake Intervention-A: 1/2 a glass of water on waking (120ml). If you forget to drink your water first thing, do not drink it later in the day, just skip this day and drink ½ a glass the next day on waking. Intervention-B: Drink extra water at anytime over 24 hours

Other: Daily extra water intakeOther: Timing of daily extra water intake

Interventions

Daily extra water intakeOTHER

Amount of extra daily water intake to consume

Daily extra water intake 120mlDaily extra water intake 1LDaily extra water intake 2LDaily extra water intake 500ml
Timing of daily extra water intakeOTHER

Intervention-A: Timing of daily extra water intake specified Intervention-B: at any time during 24 hour period

Daily extra water intake 120mlDaily extra water intake 1LDaily extra water intake 2LDaily extra water intake 500ml

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any adult (defined as someone aged 18 or above) for whom advice to drink extra water is not contraindicated.

You may not qualify if:

  • \< 18 years of age
  • No personal email address
  • Pregnancy
  • Ecstasy recreational drug use
  • Impaired renal function
  • Chronic bowel problems
  • Low sodium levels
  • Diabetes insipidus
  • Schizophrenia or history of psychosis
  • Anorexia or bulimia
  • Congestive heart failure
  • Current chemotherapy treatment
  • Taking regular non-steroidal anti-inflammatory drugs
  • Diuretics (e.g. thiazides, indapamide, loop diuretics), also called "water tablets"
  • Anti-depressants: Selective serotonin re-uptake inhibitors (SSRIs), Tricyclic and tetracyclic antidepressants (TCAs),monoamine oxidase inhibitor (MAOIs)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ThinkWell

Oxford, Oxfordshire, OX4 4DN, United Kingdom

Location

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amanda J Burls, MD

    ThinkWell and City University London

    PRINCIPAL INVESTIGATOR

  • Amy I Price, PhD

    University of Oxford

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2014

First Posted

January 5, 2015

Study Start

February 1, 2019

Primary Completion

August 1, 2019

Study Completion

November 1, 2019

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations

GB(1)