RECRUITING

Water Intake and Weight Control in Older Adults

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a randomized controlled intervention trial in adults aged 50+ years with overweight or obesity, which will compare three groups with different diet prescriptions: 1) pre-meal water consumption (500 ml, before each main meal) with a hypocaloric diet; 2) 1500 ml water consumed throughout the day with a hypocaloric diet; 3) hypocaloric diet with no instructions regarding water consumption. Smart water bottles will objectively assess water intake timing and volume. Urine osmolality, urine volume, and serum osmolality will be used as objective indicators of compliance with the water intake prescription. We will investigate changes in perceived hunger and fullness and appetite-regulating hormones as potential mechanisms by which premeal water could improve appetite regulation. We will also investigate the impact of water consumption and hydration on executive function capabilities, which may influence intervention adherence. Although increasing water intake could be an effective weight management strategy, no evidence-based recommendations exist for the timing of water intake needed for this benefit.

Official Title

Water Intake and Weight Control in Older Adults

Quick Facts

Study Start:2023-11-13
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05843318

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * aged 50+ years
  2. * BMI ≥25 kg/m2
  3. * weight stable (+/- 2 kg) in past 6 months
  4. * willing to provide consent and comply with study protocol
  1. * usual plain drinking water intake \>1500 ml/d
  2. * uncontrolled hypertension (\>159/99 mmHg)
  3. * medical condition requiring specialized diet prescription (eg, T2D, CHF wih fluid restriction)
  4. * medical condition that precludes participating in a physical activity program (eg, orthopedic injury)
  5. * current or history of GI disease (eg, Crohn's), GI surgery, or medications which impact GI function
  6. * allergies or aversions to foods included in the test meals

Contacts and Locations

Study Contact

Brenda Davy, PhD RDN
CONTACT
540-231-6784
bdavy@vt.edu
Elaina Marinik, PhD
CONTACT
540-231-0923
emarinik@vt.edu

Principal Investigator

Brenda Davy, PhD RDN
PRINCIPAL_INVESTIGATOR
Virginia Polytechnic Institute and State University

Study Locations (Sites)

Virginia Tech
Blacksburg, Virginia, 24061
United States

Collaborators and Investigators

Sponsor: Virginia Polytechnic Institute and State University

  • Brenda Davy, PhD RDN, PRINCIPAL_INVESTIGATOR, Virginia Polytechnic Institute and State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-13
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2023-11-13
Study Completion Date2028-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Overweight and Obesity