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Drinking Extra Water for to Prevent or Decrease Headaches

Not Applicable
Withdrawn
Conditions
Headache
Interventions
Other: Daily extra water intake
Other: Timing of daily extra water intake
Registration Number
NCT02330809
Lead Sponsor
ThinkWell
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?

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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Daily extra water intake 1LDaily 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 120mlTiming 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
Daily extra water intake 2LTiming 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 2LDaily 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 120mlDaily 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
Daily extra water intake 1LTiming 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 500mlDaily 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 500mlTiming 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
Primary Outcome Measures
NameTimeMethod
Reduction of headache frequency/intensityDaily for 14 days

Online participant reported visual analog scales

Secondary Outcome Measures
NameTimeMethod
Body mass index (BMI)Baseline and day 14

Participants will use an automated online BMI calculator

WellbeingBaseline and day 14

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.

HungerDaily for 14 days

Online participant reported Visual analog scales

Mood QuestionnaireDaily for 14 days

Mood will be measured online using happy, sad, neutral faces

Trial Locations

Locations (1)

ThinkWell

🇬🇧

Oxford, Oxfordshire, United Kingdom

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