Drinking Water to Reach or Maintain a Healthier Weight

Sponsor

ThinkWell (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02331316

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Dietary Modification	Other: Daily extra water intake	N/A

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

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Drinking Water To Prevent or Reduce Weight Gain - An Online Randomized Controlled Trial With Adult Participants

Anticipated Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Aug 1, 2019

Anticipated Study Completion Date :

Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 Intervention-A: Timing of assigned daily extra water intake specified Intervention-B: Daily extra water assigned 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 Intervention-A: Timing of assigned daily extra water intake specified Intervention-B: Daily extra water assigned 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 Intervention-A: Timing of assigned daily extra water intake specified Intervention-B: Daily extra water assigned 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 Intervention-A: Timing of assigned daily extra water intake specified Intervention-B: Daily extra water assigned at any time during 24 hour period

Outcome Measures

Primary Outcome Measures

Weight loss or maintenance recorded online using participant reported outcome measures(PROMS) [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

Secondary Outcome Measures

Hunger intensity and satiety recorded online using participant reported outcome measures(PROMS) [6 months]
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
Well-being as measured by The PROMIS Well-being measure [6 months]
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
Nightly micturition frequency as measured by self report [6 months]
Participants will self report weekly if nightly micturition frequency increases, decreases or there is no change

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

General:

< 18 years of age
No personal email address
Pregnancy
Ecstasy recreational drug use

Health conditions:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ThinkWell and City University London	Oxford	Oxfordshire	United Kingdom	OX4 4DN

Sponsors and Collaborators

ThinkWell

Investigators

Principal Investigator: Amanda J Burls, MD, ThinkWell and City University London
Principal Investigator: Martin Cartwright, PhD, City, University of London