ObesityNCT02331316
Drinking Water to Reach or Maintain a Healthier Weight
A study testing Daily extra water intake in people with Obesity and Dietary Modification, run by ThinkWell at 1 site in United Kingdom.
Trial summary
The purpose of this study is to find out if drinking extra water helps people lose or maintain weight loss and reduce hunger and, if so, what volume of water is most effective and when is it best to drink it. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Dietary Modification
- What is being tested?
- Daily extra water intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2019to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any adult (defined as someone aged 18 or above) for who advice to drink extra water is not contraindicated.
Who cannot join
- General:
- < 18 years of age
- No personal email address
- Pregnancy
- Ecstasy recreational drug use
- Health conditions:
Show all 24Show fewer
- Impaired renal function
- Chronic bowel problems
- Low sodium levels
- Diabetes insipidus
- Schizophrenia or history of psychosis
- Congestive heart failure
- Current chemotherapy treatment
- Anorexia
- bulimia
- 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)
- Implicit exclusions:
- People without internet access
- People who cannot read 3 People without the ability to understand the website and informed consent documents
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
ThinkWell and City University London
Oxford, Oxfordshire, OX4 4DN
About this study
Official title: Drinking Water To Prevent or Reduce Weight Gain - An Online Randomized Controlled Trial With Adult Participants
The purpose of this study is to find out if drinking extra water helps people lose or maintain weight loss and reduce hunger and, if so, what volume of water is most effective and when is it best to drink it.
Read the detailed description
Obesity is a major public health problem. Observational data suggest that drinking water is associated with a healthier weight. Indeed advice to drink extra water to help with weight control is widespread (eight 8oz glasses or 2L of water a day is a common recommendation). The public spends billions of dollars on bottled water in the belief that it works and people are increasingly carrying water with them throughout the day. However, a systematic review of randomized controlled trials looking at the effectiveness of drinking extra water to help reduce weight or weight gain or produce changes in surrogate markers such as appetite or caloric intake undertaken by our group showed that currently there is an absence of reliable evidence to support the recommendation to drink water.
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:
- Does drinking water reduce hunger or increase satiety
- Does drinking water increase participants' sense of well-being
- 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
- Obesity, Dietary Modification
- Being tested
- Daily extra water intake
- Keywords
- obesity, diet, weight, hunger, public led trial
- Medical subject headings
- Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily extra water intakeOther
Intervention-A: Timing of assigned daily extra water intake specified
Intervention-B: Daily extra water assigned at any time during 24 hour period
| Study group | Role | What they receive |
|---|---|---|
| Daily extra water intake 2L | Experimental | 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 Receives: Other: Daily extra water intake |
| Daily extra water intake 1L | Experimental | 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 Receives: Other: Daily extra water intake |
| Daily extra water intake 500ml | Experimental | 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 Receives: Other: Daily extra water intake |
| Daily extra water intake 120ml | Experimental | 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 Receives: Other: Daily extra water intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss or maintenance recorded online using participant reported outcome measures(PROMS)
Weight loss or maintenance recorded online using participant reported outcome measures(PROMS). Participants will be asked to record weight using a supplied body mass index calculator and home weight scales weekly or as a minimum at baseline and close of study
Measured: 6 months
Secondary outcomes (3)
Hunger intensity and satiety recorded online using participant reported outcome measures(PROMS)
Hunger intensity and satiety recorded online using participant reported outcome measures(PROMS). Participants will be asked to self report hunger and satiety levels using a mobile app, web or journal using a visual analog scale (VAS ) on a daily basis or as a minimum at baseline and close of study
Measured: 6 months
Well-being as measured by The PROMIS Well-being measure
The PROMIS Well-being measure will be administered to participants monthly,
There will be a VAS Mood scale where they can record sad to happy mood at the same time they record hunger
Measured: 6 months
Nightly micturition frequency as measured by self report
Participants will self report weekly if nightly micturition frequency increases, decreases or there is no change
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJan 2019 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionNov 2019 (estimated)
Why it stopped: PI Retired study unfunded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThinkWell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda J Burls, MD, Principal investigator, ThinkWell and City University LondonMartin Cartwright, PhD, Principal investigator, City, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331316
- Sponsor's protocol ID
- ThinkWell PLOT-02
- Status last verified
- Mar 2021
- First submitted
- 1 Jan 2015
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drinking Water To Prevent or Reduce Weight Gain - An Online Randomized Controlled Trial With Adult Participants
- ClinicalTrials.gov ID
- NCT02331316
- Acronym / sponsor ID
- ThinkWell PLOT-02
- Conditions
- Obesity, Dietary Modification
- Keywords
- obesity, diet, weight, hunger, public led trial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI Retired study unfunded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ThinkWellUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if drinking extra water helps people lose or maintain weight loss and reduce hunger and, if so, what volume of water is most effective and when is it best to drink it.
Detailed description
Obesity is a major public health problem. Observational data suggest that drinking water is associated with a healthier weight. Indeed advice to drink extra water to help with weight control is widespread (eight 8oz glasses or 2L of water a day is a common recommendation). The public spends billions of dollars on bottled water in the belief that it works and people are increasingly carrying water with them throughout the day. However, a systematic review of randomized controlled trials looking at the effectiveness of drinking extra water to help reduce weight or weight gain or produce changes in surrogate markers such as appetite or caloric intake undertaken by our group showed that currently there is an absence of reliable evidence to support the recommendation to drink water.
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:
- Does drinking water reduce hunger or increase satiety
- Does drinking water increase participants' sense of well-being
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Daily extra water intake 2L | Experimental | Other: 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 1L | Experimental | Other: 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 500ml | Experimental | Other: 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 |
| Daily extra water intake 120ml | Experimental | Other: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult (defined as someone aged 18 or above) for who advice to drink extra water is not contraindicated.
Key exclusion criteria (24 listed)
- < 18 years of age
- No personal email address
- Pregnancy
- Ecstasy recreational drug use
- Impaired renal function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily extra water intakeIntervention-A: Timing of assigned daily extra water intake specified Intervention-B: Daily extra water assigned at any time during 24 hour period | Other | Daily extra water intake 120ml, Daily extra water intake 1L, Daily extra water intake 2L, Daily extra water intake 500ml |
Primary outcome
Weight loss or maintenance recorded online using participant reported outcome measures(PROMS)
Time frame: 6 months
Weight loss or maintenance recorded online using participant reported outcome measures(PROMS). Participants will be asked to record weight using a supplied body mass index calculator and home weight scales weekly or as a minimum at baseline and close of study
3 secondary outcomes
Hunger intensity and satiety recorded online using participant reported outcome measures(PROMS)
Time frame: 6 months
Well-being as measured by The PROMIS Well-being measure
Time frame: 6 months
Nightly micturition frequency as measured by self report
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Background1 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
- Background1 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda J Burls, MD principal investigator
ThinkWell and City University London
Martin Cartwright, PhD principal investigator
City, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily extra water intake in people with Obesity and Dietary Modification, run by ThinkWell at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss or maintenance recorded online using participant reported outcome measures(PROMS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02331316, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.