Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-01-31
2019-11-30
Brief Summary
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Detailed Description
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It is important to establish whether drinking extra water is indeed helpful for weight control and, if so, what is the optimal quantity to recommend, as this could have an important impact of public health and public health policies if it is indeed effective. Tap water is so readily available in this country that even if the improvement in weight maintenance or reduction is small, this will be a cost-effective intervention. If it is not effective, then it is important that people know this so that they can make an informed choice about buying bottles of water for their health.
The primary clinical question the study will address is does drinking extra water prevent or reduce weight gain?
The secondary clinical questions it will ask are:
1. Does drinking water reduce hunger or increase satiety
2. Does drinking water increase participants' sense of well-being
3. What is the effect of the different volumes of water on nocturnal urination patterns?
Once participants decide to take part in this trial, they will be asked to drink a specific amount of water at particular times of the day for 6 months. 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 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 a participant 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.
Participant will be asked to provide some brief information about themselves at the beginning of the study (for example, age, sex, height and whether they 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 stored 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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
Daily extra water intake
Intervention-A: Timing of assigned daily extra water intake specified
Intervention-B: Daily extra water assigned at any time during 24 hour period
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
Daily extra water intake
Intervention-A: Timing of assigned daily extra water intake specified
Intervention-B: Daily extra water assigned at any time during 24 hour period
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
Daily extra water intake
Intervention-A: Timing of assigned daily extra water intake specified
Intervention-B: Daily extra water assigned at any time during 24 hour period
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
Daily extra water intake
Intervention-A: Timing of assigned daily extra water intake specified
Intervention-B: Daily extra water assigned at any time during 24 hour period
Interventions
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Daily extra water intake
Intervention-A: Timing of assigned daily extra water intake specified
Intervention-B: Daily extra water assigned at any time during 24 hour period
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1. \< 18 years of age
2. No personal email address
3. Pregnancy
4. Ecstasy recreational drug use
Health conditions:
1. Impaired renal function
2. Chronic bowel problems
3. Low sodium levels
4. Diabetes insipidus
5. Schizophrenia or history of psychosis
6. Congestive heart failure
7. Current chemotherapy treatment
8. Anorexia
9. bulimia
Concurrent Medications:
1. Taking regular non-steroidal anti-inflammatory drugs
2. Diuretics (e.g. thiazides, indapamide, loop diuretics), also called "water tablets"
3. Anti-depressants Selective serotonin re-uptake inhibitors (SSRIs), Tricyclic and tetracyclic antidepressants (TCAs),monoamine oxidase inhibitor (MAOIs)
4. Anti-psychotics (e.g. haloperidol)
5. Anti-convulsants (e.g. sodium valproate, carbamazepine)
Implicit exclusions:
1. People without internet access
2. People who cannot read 3 People without the ability to understand the website and informed consent documents
18 Years
ALL
Yes
Sponsors
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ThinkWell
OTHER
Responsible Party
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Principal Investigators
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Amanda J Burls, MD
Role: PRINCIPAL_INVESTIGATOR
ThinkWell and City University London
Martin Cartwright, PhD
Role: PRINCIPAL_INVESTIGATOR
City, University of London
Locations
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ThinkWell and City University London
Oxford, Oxfordshire, United Kingdom
Countries
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References
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1 Price A, Burls A, Spurden D, et al. Water intake for weight reduction: a Systematic Review. PROSPERO. 2013.http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42013004998
1 Price A, Burls A. PLOT-IT Public Led Online Trials Infrastructure and Tools. In: Force 2015. Oxford UK: : Force2015 2015. doi:DOI: 10.13140/2.1.1992.6082
Other Identifiers
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ThinkWell PLOT-02
Identifier Type: -
Identifier Source: org_study_id
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