ACTIVE_NOT_RECRUITING

Health Effects of Substituting Sugary Beverages With Artificially-sweetened Beverages or Water

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

Sugar-sweetened beverages (SSBs) contribute an alarming \~7% of calories in the US diet among adults, making SSBs the single largest source of added sugar. However, whether artificially sweetened beverages are a healthful alternative for reducing SSB intake among habitual SSB consumers is unknown. Therefore, the investigators will conduct a 4-arm randomized diet intervention trial to test the effects of substituting SSBs with calorie-free alternatives on body weight and health, among habitual SSB consumers with overweight/obesity.

Official Title

SUBstituting With Preferred Options: Health Effects of Substituting Sugar-sweetened Beverages With Non-caloric Beverages in Adults With Overweight and Obesity

Quick Facts

Study Start:2021-04-22
Study Completion:2026-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04567108

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:20 Years to 69 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults aged 20-69 years
  2. 2. Consume ≥1 serving/day (12 oz.) of SSBs (SSBs include soda, fruit drinks, energy drinks, sports drinks, and sweetened waters, sweetened with high fructose corn syrup, sucrose, or fruit juices. SSBs do not include 100% fruit juice, sweetened teas, or flavored milk.)
  3. 3. BMI 25.0 to 45.0 kg/m2
  4. 4. Access to a smartphone and willingness and ability to download study app
  5. 5. Willing to consume beverages consistent with any of the 4 possible group assignments for 6 months
  1. 1. Physician diagnosis of T2D or fasting glucose ≥126 mg/dL at in-person screening visit
  2. 2. Intention to move away from greater Boston area within 1 year from randomization
  3. 3. Major medical illness (known cardiovascular disease, cancer, kidney disease, cirrhosis, etc.)
  4. 4. Phenylketonuria (PKU)
  5. 5. Medication that may affect weight or other study endpoints
  6. 6. Another family or household member participating in the study
  7. 7. Pregnant in the past 12 months, currently breastfeeding, or planning to become pregnant during the study period

Contacts and Locations

Principal Investigator

Deirdre Tobias, ScD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Deirdre Tobias, ScD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

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 Date2021-04-22
Study Completion Date2026-03-01

Study Record Updates

Study Start Date2021-04-22
Study Completion Date2026-03-01

Terms related to this study

Keywords Provided by Researchers

  • Prevention
  • Weight control
  • Sugar-sweetened beverages
  • Artificial sweeteners
  • Water
  • Beverages

Additional Relevant MeSH Terms

  • Body Weight