HeadacheNCT02330809
Drinking Extra Water for to Prevent or Decrease Headaches
A study testing Daily extra water intake and Timing of daily extra water intake in people with Headache, run by ThinkWell at 1 site in United Kingdom.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache
- What is being tested?
- Daily extra water intake and Timing of daily extra water intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2019to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any adult (defined as someone aged 18 or above) for whom advice to drink extra water is not contraindicated.
Who cannot join
- General exclusions
- < 18 years of age
- No personal email address
- Pregnancy
- Ecstasy recreational drug use
- Exclusions Health Conditions
Show all 25Show fewer
- 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
- Exclusions Concurrent Medications
- 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)
- Anti-psychotics (e.g. haloperidol)
- Anti-convulsants (e.g. sodium valproate, carbamazepine)
- Cancer drugs (anti-neoplastic agents)
- Implicit exclusions
- People without internet access
- People who cannot read
- People without the ability to understand the website and informed consent documents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drinking Extra Water To Prevent or Decrease Headaches - A Feasibility Online Randomized Controlled Trial With Adult Participants
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?
Read the detailed description
If participants decide to participate in this trial, they will be asked to drink a specific amount of water at particular times of the day for 14 days. A computer will decide by chance the amount of water they will be asked to drink each day of the trial and the times at which to drink this.
There are different amounts and different times that people will be asked to drink water, this is so that the investigators can find out if there is an optimal volume of water to drink, and a best time to drink water to reduce headaches or hunger. The least amount of water the computer could ask participants to drink is half a glass (that is 4oz or 120ml). The largest volume of water the computer could ask participants to drink would be eight glasses of water a day (a total of 64oz or 2L) spread across the day (that is not all at once). Once the computer has assigned participants to a particular volume and times to drink water, these will remain the same for every day throughout the study.
Participants will be asked to provide some brief information about themselves at the beginning of the study (for example, age, sex, height and whether you exercise, smoke or not). During the study they will be asked to weigh themselves and record this, Their dietary habits and the amount they drink will be kept on a private and confidential page on the study website. They will be asked to fill in [2] confidential short surveys about how they feel and their views, one at the start and one at the end of the study.
- Conditions
- Headache
- Being tested
- Daily extra water intake, Timing of daily extra water intake
- Keywords
- headache, hunger intensity, public led online trial, water intake
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily extra water intakeOther
Amount of extra daily water intake to consume
Timing of daily extra water intakeOther
Intervention-A: Timing of daily extra water intake specified Intervention-B: at any time during 24 hour period
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Daily extra water intake; Other: 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 Receives: Other: Daily extra water intake; Other: 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 Receives: Other: Daily extra water intake; Other: 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 Receives: Other: Daily extra water intake; Other: Timing of daily extra water intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of headache frequency/intensity
Online participant reported visual analog scales
Measured: Daily for 14 days
Secondary outcomes (4)
Hunger
Online participant reported Visual analog scales
Measured: Daily for 14 days
Mood Questionnaire
Mood will be measured online using happy, sad, neutral faces
Measured: Daily for 14 days
Body mass index (BMI)
Participants will use an automated online BMI calculator
Measured: Baseline and day 14
Wellbeing
Patient Reported Outcome Measurement Information System (PROMIS) will be used to measure patient-reported outcome (PRO) for answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function.
Measured: Baseline and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startFeb 2019 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionNov 2019 (estimated)
Why it stopped: Study investigator retired and study not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThinkWell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda J Burls, MD, Principal investigator, ThinkWell and City University LondonAmy I Price, PhD, Study director, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330809
- Sponsor's protocol ID
- ThinkWell-PLOT-01
- Status last verified
- Mar 2021
- First submitted
- 30 Dec 2014
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drinking Extra Water To Prevent or Decrease Headaches - A Feasibility Online Randomized Controlled Trial With Adult Participants
- ClinicalTrials.gov ID
- NCT02330809
- Acronym / sponsor ID
- ThinkWell-PLOT-01
- Conditions
- Headache
- Keywords
- headache, hunger intensity, public led online trial, water intake
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study investigator retired and study not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ThinkWellUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 5 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
If participants decide to participate in this trial, they will be asked to drink a specific amount of water at particular times of the day for 14 days. A computer will decide by chance the amount of water they will be asked to drink each day of the trial and the times at which to drink this.
There are different amounts and different times that people will be asked to drink water, this is so that the investigators can find out if there is an optimal volume of water to drink, and a best time to drink water to reduce headaches or hunger. The least amount of water the computer could ask participants to drink is half a glass (that is 4oz or 120ml). The largest volume of water the computer could ask participants to drink would be eight glasses of water a day (a total of 64oz or 2L) spread across the day (that is not all at once). Once the computer has assigned participants to a particular volume and times to drink water, these will remain the same for every day throughout the study.
Participants will be asked to provide some brief information about themselves at the beginning of the study (for example, age, sex, height and whether you exercise, smoke or not). During the study they will be asked to weigh themselves and record this, Their dietary habits and the amount they drink will be kept on a private and confidential page on the study website. They will be asked to fill in [2] confidential short surveys about how they feel and their views, one at the start and one at the end of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Daily extra water intake 2L | Experimental | Other: Daily extra water intake, Other: Timing of daily extra water intakeTiming 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 |
| Daily extra water intake 1L | Experimental | Other: Daily extra water intake, Other: Timing of daily extra water intakeTiming 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 |
| Daily extra water intake 500ml | Experimental | Other: Daily extra water intake, Other: Timing of daily extra water intakeTiming 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 |
| Daily extra water intake 120ml | Experimental | Other: Daily extra water intake, Other: Timing of daily extra water intakeTiming 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult (defined as someone aged 18 or above) for whom advice to drink extra water is not contraindicated.
Key exclusion criteria (25 listed)
- General exclusions
- < 18 years of age
- No personal email address
- Pregnancy
- Ecstasy recreational drug use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily extra water intakeAmount of extra daily water intake to consume | Other | Daily extra water intake 120ml, Daily extra water intake 1L, Daily extra water intake 2L, Daily extra water intake 500ml |
| Timing of daily extra water intakeIntervention-A: Timing of daily extra water intake specified Intervention-B: at any time during 24 hour period | Other | Daily extra water intake 120ml, Daily extra water intake 1L, Daily extra water intake 2L, Daily extra water intake 500ml |
Primary outcome
Reduction of headache frequency/intensity
Time frame: Daily for 14 days
Online participant reported visual analog scales
4 secondary outcomes
Hunger
Time frame: Daily for 14 days
Mood Questionnaire
Time frame: Daily for 14 days
Body mass index (BMI)
Time frame: Baseline and day 14
Wellbeing
Time frame: Baseline and day 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda J Burls, MD principal investigator
ThinkWell and City University London
Amy I Price, PhD study director
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily extra water intake and Timing of daily extra water intake in people with Headache, run by ThinkWell at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of headache frequency/intensity (time frame: Daily for 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.