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Study investigator retired and study not funded
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily extra water intake | Other | Amount of extra daily water intake to consume |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of headache frequency/intensity | Online participant reported visual analog scales | Daily for 14 days |
| 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 |
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Inclusion Criteria
Exclusion Criteria
General exclusions
Exclusions Health Conditions
Exclusions Concurrent Medications
Implicit exclusions
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| Name | Affiliation | Role |
|---|---|---|
| Amanda J Burls, MD | ThinkWell and City University London | Principal Investigator |
| Amy I Price, PhD | University of Oxford | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ThinkWell | Oxford | Oxfordshire | OX4 4DN | United Kingdom |
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| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Timing of daily extra water intake | Other | Intervention-A: Timing of daily extra water intake specified Intervention-B: at any time during 24 hour period |
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| 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 |