Drinking Water to Reach or Maintain a Healthier Weight

NCT ID: NCT02331316

Last Updated: 2021-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2019-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

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

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Dietary Modification

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Daily extra water intake

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Daily extra water intake

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Daily extra water intake

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Daily extra water intake

Intervention Type OTHER

Intervention-A: Timing of assigned daily extra water intake specified

Intervention-B: Daily extra water assigned at any time during 24 hour period

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Any adult (defined as someone aged 18 or above) for who advice to drink extra water is not contraindicated.

Exclusion Criteria

General:

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ThinkWell

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amanda J Burls, MD

Role: PRINCIPAL_INVESTIGATOR

ThinkWell and City University London

Martin Cartwright, PhD

Role: PRINCIPAL_INVESTIGATOR

City, University of London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ThinkWell and City University London

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ThinkWell PLOT-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Supplemental Calcium in Overweight People
NCT00030238 COMPLETED PHASE3
Attentive Eating for Weight Loss
NCT03602001 COMPLETED NA
Lowering Caloric Density of the Diet
NCT02674971 ACTIVE_NOT_RECRUITING NA
Fat Burning After a Meal
NCT02211599 COMPLETED NA