Drinking Extra Water for to Prevent or Decrease Headaches

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?

Study Overview

• Status: Withdrawn
• Conditions: Headache
• Intervention / Treatment: Other: Daily extra water intake; Other: Timing of daily extra water intake

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX4 4DN
      • ThinkWell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ThinkWell
• Investigators: Study Director: Amy I Price, PhD, University of Oxford

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: December 30, 2014
• First Submitted That Met QC Criteria: January 2, 2015
• First Posted (Estimate): January 5, 2015

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: headache; hunger intensity; public led online trial; water intake
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: ThinkWell-PLOT-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No