Effects of replacing sugary drinks with low-calorie options on health
SUBstituting With Preferred Options: Health Effects of Substituting Sugar-sweetened Beverages With Non-caloric Beverages in Adults With Overweight and Obesity
NA · Brigham and Women's Hospital · NCT04567108
This study tests if replacing sugary drinks with low-calorie options can help adults who are overweight or obese improve their health and lose weight.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 20 Years to 69 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04567108 on ClinicalTrials.gov |
What this trial studies
This trial investigates the health effects of substituting sugary beverages with calorie-free alternatives among adults with overweight or obesity who regularly consume sugary drinks. Participants will be randomly assigned to one of four beverage groups and will receive monthly deliveries of their assigned beverages for six months. The study will assess changes in body weight and health markers through in-person visits and app-based monitoring. After the intervention, participants will switch to water-only consumption for an additional six months to evaluate long-term effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-69 who consume at least one serving of sugary beverages daily and have a BMI between 25.0 and 45.0 kg/m2.
Not a fit: Patients with a diagnosis of type 2 diabetes or other major medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective strategies for weight management and improving metabolic health by reducing sugary beverage intake.
How similar studies have performed: Previous studies have shown promising results in reducing body weight and improving health markers through similar dietary interventions, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults aged 20-69 years 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. BMI 25.0 to 45.0 kg/m2 4. Access to a smartphone and willingness and ability to download study app 5. Willing to consume beverages consistent with any of the 4 possible group assignments for 6 months Exclusion Criteria: 1. Physician diagnosis of T2D or fasting glucose ≥126 mg/dL at in-person screening visit 2. Intention to move away from greater Boston area within 1 year from randomization 3. Major medical illness (known cardiovascular disease, cancer, kidney disease, cirrhosis, etc.) 4. Phenylketonuria (PKU) 5. Medication that may affect weight or other study endpoints 6. Another family or household member participating in the study 7. Pregnant in the past 12 months, currently breastfeeding, or planning to become pregnant during the study period
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Deirdre Tobias, ScD — Brigham and Women's Hospital
- Study coordinator: Deirdre K Tobias, ScD
- Email: dtobias@bwh.harvard.edu
- Phone: 617-732-5500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Body Weight, Prevention, Weight control, Sugar-sweetened beverages, Artificial sweeteners, Water, Beverages