An interventional study of Daily extra water intake in Obesity and Dietary Modification, sponsored by ThinkWell. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-23.
Sponsored by ThinkWell · Not applicable, Interventional, and Prevention
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.
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:
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
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
General:
Health conditions:
Concurrent Medications:
Implicit exclusions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
Time frame: 6 months
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
Time frame: 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
Time frame: 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
Time frame: 6 months
This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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