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Drinking Extra Water for to Prevent or Decrease Headaches

This study is not yet open for participant recruitment.
Verified November 2016 by ThinkWell
Sponsor:
ClinicalTrials.gov Identifier:
NCT02330809
First Posted: January 5, 2015
Last Update Posted: November 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
ThinkWell
  Purpose
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?

Condition Intervention
Headache Other: Daily extra water intake Other: Timing of daily extra water intake

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Drinking Extra Water To Prevent or Decrease Headaches - A Feasibility Online Randomized Controlled Trial With Adult Participants

Resource links provided by NLM:


Further study details as provided by ThinkWell:

Primary Outcome Measures:
  • Reduction of headache frequency/intensity [ Time Frame: Daily for 14 days ]
    Online participant reported visual analog scales


Secondary Outcome Measures:
  • Hunger [ Time Frame: Daily for 14 days ]
    Online participant reported Visual analog scales

  • Mood Questionnaire [ Time Frame: Daily for 14 days ]
    Mood will be measured online using happy, sad, neutral faces

  • Body mass index (BMI) [ Time Frame: Baseline and day 14 ]
    Participants will use an automated online BMI calculator

  • Wellbeing [ Time Frame: Baseline 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.


Estimated Enrollment: 9600
Study Start Date: February 2018
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330809


Locations
United Kingdom
ThinkWell Not yet recruiting
Oxford, Oxfordshire, United Kingdom, OX4 4DN
Contact: Amy I Price, PhD    0208 884 2282    dr.amyprice@gmail.com   
Sub-Investigator: Amy I Price, PhD         
Principal Investigator: Amanda J Burls, MD         
Sponsors and Collaborators
ThinkWell
Investigators
Principal Investigator: Amanda J Burls, MD University of Oxford
Study Director: Amy I Price, PhD University of Oxford
  More Information

Responsible Party: ThinkWell
ClinicalTrials.gov Identifier: NCT02330809     History of Changes
Other Study ID Numbers: ThinkWell-PLOT-01
First Submitted: December 30, 2014
First Posted: January 5, 2015
Last Update Posted: November 7, 2016
Last Verified: November 2016

Keywords provided by ThinkWell:
headache
hunger intensity
public led online trial
water intake

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms