Drinking Water To Prevent or Reduce Weight Gain - An Online Randomized Controlled Trial With Adult Participants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 2
- Primary Endpoint
- Weight loss or maintenance recorded online using participant reported outcome measures(PROMS)
Study Overview
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.
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?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •< 18 years of age
- •No personal email address
- •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
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Nightly micturition frequency as measured by self report(6 months)
- Well-being as measured by The PROMIS Well-being measure(6 months)
- Hunger intensity and satiety recorded online using participant reported outcome measures(PROMS)(6 months)