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Drinking Extra Water for to Prevent or Decrease Headaches

Primary Purpose

Headache

Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Daily extra water intake
Timing of daily extra water intake
Sponsored by
ThinkWell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Headache focused on measuring headache, hunger intensity, public led online trial, water intake

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ThinkWell

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Daily extra water intake 2L

Daily extra water intake 1L

Daily extra water intake 500ml

Daily extra water intake 120ml

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Reduction of headache frequency/intensity
Online participant reported visual analog scales

Secondary Outcome Measures

Hunger
Online participant reported Visual analog scales
Mood Questionnaire
Mood will be measured online using happy, sad, neutral faces
Body mass index (BMI)
Participants will use an automated online BMI calculator
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.

Full Information

First Posted
December 30, 2014
Last Updated
March 18, 2021
Sponsor
ThinkWell
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1. Study Identification

Unique Protocol Identification Number
NCT02330809
Brief Title
Drinking Extra Water for to Prevent or Decrease Headaches
Official Title
Drinking Extra Water To Prevent or Decrease Headaches - A Feasibility Online Randomized Controlled Trial With Adult Participants
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study investigator retired and study not funded
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ThinkWell

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
headache, hunger intensity, public led online trial, water intake

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily extra water intake 2L
Arm Type
Experimental
Arm Description
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
Arm Title
Daily extra water intake 1L
Arm Type
Experimental
Arm Description
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
Arm Title
Daily extra water intake 500ml
Arm Type
Experimental
Arm Description
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
Arm Title
Daily extra water intake 120ml
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Daily extra water intake
Intervention Description
Amount of extra daily water intake to consume
Intervention Type
Other
Intervention Name(s)
Timing of daily extra water intake
Intervention Description
Intervention-A: Timing of daily extra water intake specified Intervention-B: at any time during 24 hour period
Primary Outcome Measure Information:
Title
Reduction of headache frequency/intensity
Description
Online participant reported visual analog scales
Time Frame
Daily for 14 days
Secondary Outcome Measure Information:
Title
Hunger
Description
Online participant reported Visual analog scales
Time Frame
Daily for 14 days
Title
Mood Questionnaire
Description
Mood will be measured online using happy, sad, neutral faces
Time Frame
Daily for 14 days
Title
Body mass index (BMI)
Description
Participants will use an automated online BMI calculator
Time Frame
Baseline and day 14
Title
Wellbeing
Description
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.
Time Frame
Baseline and day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda J Burls, MD
Organizational Affiliation
ThinkWell and City University London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amy I Price, PhD
Organizational Affiliation
University of Oxford
Official's Role
Study Director
Facility Information:
Facility Name
ThinkWell
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX4 4DN
Country
United Kingdom

12. IPD Sharing Statement

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Drinking Extra Water for to Prevent or Decrease Headaches

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