Drinking Extra Water for to Prevent or Decrease Headaches

Study Overview
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Brief Summary
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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
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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.

Official Title
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Drinking Extra Water To Prevent or Decrease Headaches - A Feasibility Online Randomized Controlled Trial With Adult Participants

Conditions
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Headache

Intervention / Treatment
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* Other: Daily extra water intake
* Other: Timing of daily extra water intake


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Any adult (defined as someone aged 18 or above) for whom advice to drink extra water is not contraindicated. Exclusion Criteria General exclusions < 18 years of age No personal email address Pregnancy Ecstasy recreational drug use Exclusions Health Conditions 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily extra water intake 2L<br>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 intake<br>* Amount of extra daily water intake to consume<br>Other: Timing of daily extra water intake<br>* Intervention-A: Timing of daily extra water intake specified Intervention-B: at any time during 24 hour period<br>|
| Experimental: Daily extra water intake 1L<br>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 intake<br>* Amount of extra daily water intake to consume<br>Other: Timing of daily extra water intake<br>* Intervention-A: Timing of daily extra water intake specified Intervention-B: at any time during 24 hour period<br>|
| Experimental: Daily extra water intake 500ml<br>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 intake<br>* Amount of extra daily water intake to consume<br>Other: Timing of daily extra water intake<br>* Intervention-A: Timing of daily extra water intake specified Intervention-B: at any time during 24 hour period<br>|
| Experimental: Daily extra water intake 120ml<br>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 intake<br>* Amount of extra daily water intake to consume<br>Other: Timing of daily extra water intake<br>* Intervention-A: Timing of daily extra water intake specified Intervention-B: at any time during 24 hour period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of headache frequency/intensity | Online participant reported visual analog scales | Daily for 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hunger | Online participant reported Visual analog scales | Daily for 14 days | 
| Mood Questionnaire | Mood will be measured online using happy, sad, neutral faces | Daily for 14 days | 
| Body mass index (BMI) | Participants will use an automated online BMI calculator | 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. | Baseline and day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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headache, hunger intensity, public led online trial, water intake