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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK125803-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
The SUBstituting with Preferred OPtions (SUB-POP) trial, is a parallel-arm randomized controlled trial (RCT) to test the effects of substituting SSBs with non-caloric options on body weight and markers of type 2 diabetes and cardiometabolic health. Eligible adult participants will be randomized to 1 of 4 beverage groups and receive at-home monthly deliveries of beverages for 6 months. In-person clinic visits will be conducted at baseline, 6, and 12 months. After the 6 months of assigned beverage substitution and delivery, all participants will be instructed to substitute SSBs with water only for a final 6-month observational period. In-person clinic visits will collect technician-measured anthropometrics, blood pressure, biospecimen samples (blood, urine, stool [subset]), and assess physical activity, diet, beverage frequency, and taste preference. The SUB-POP app-based assessments and online diet recall will ascertain daily beverage intake, while diet (via 3 24-hour recalls), physical activity, and overall beverage frequency will be collected every 1-3 months. A subset will receive at-home digital scales to transmit daily body weight for energy balance and caloric compensation modeling. SUB-POP is a novel RCT that will enroll adult regular SSB consumers with overweight or obesity to evaluate the effectiveness of substituting SSBs with non-caloric options in a real-world, un-blinded setting. The trial will leverage social media recruitment methods, achieve ≥30% non-White participants, implement innovative intervention delivery, adherence, and data collection tools, and partition the artificially-sweetened beverage (ASB) substitution intervention to the two most common artificial sweetener types (aspartame, sucralose) to explore potential heterogeneity. Whether ASBs, which are largely free of calories and sugar, provide a healthful interim strategy to transition to water among habitual SSB consumers is unknown. Thus, by addressing this large gap in the understanding of how to address a highly prevalent and concerning dietary exposure, the investigators will inform dietary guidelines and clinical recommendations for the prevention of obesity, type 2 diabetes, and cardiometabolic disease risks. The primary outcomes are change in body weight from baseline to 6 months between the 3 beverage substitution groups (aspartame ASBs, sucralose ASBs, and water) vs. the maintain SSBs control group, adjusting for multiple comparisons. The investigators and staff will be blinded to group assignment at outcome assessments. Intention-to-treat analysis will be used.
After 9/1/2023 the 2 ASB intervention groups (sucralose, aspartame) are combined into a single ASB intervention group; participants randomized on or after 9/1/2023 will be randomized to 1 of 3 beverage groups: maintain SSBs (months 0-6; then switch to water months 6-12); switch to ASBs (months 0-6; then switch to water months 6-12); switch to water (months 0-12). The primary outcomes are change in body weight from baseline to 6 months between the 2 beverage substitution groups (ASBs [all ASB intervention groups combined] and water) vs. the maintain SSBs control group, adjusting for multiple comparisons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maintain SSBs (Control) | Active Comparator | Instruction to maintain baseline intake of SSBs (months 0-6); then switch to water only (months 6-12) |
|
| Substitute Aspartame ASBs (participants randomized through 8/31/2023) | Experimental | Instruction/guidelines to eliminate SSBs and replace, where possible with beverages artificially sweetened with aspartame (months 0-6); then switch to water only (months 6-12) |
|
| Substitute Sucralose ASBs (participants randomized through 8/31/2023) | Experimental | Instruction/guidelines to eliminate SSBs and replace, where possible with beverages artificially sweetened with sucralose (months 0-6); then switch to water only (months 6-12) |
|
| Substitute Water | Experimental | Instruction/guidelines to eliminate SSBs and replace with water (months 0-12) |
|
| Substitute ASBs (participants randomized on or after 9/1/2023) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maintain usual SSBs | Behavioral | Instruction/guidelines to maintain baseline intake of SSBs (months 0-6); then switch to water only (months 6-12) |
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| Measure | Description | Time Frame |
|---|---|---|
| Weight Change at 6 months | Change in total body weight calculated as the month 6 weight minus the baseline weight | Baseline, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Waist Circumference Change | Calculated as month 6 minus baseline value | Baseline, Month 6 |
| Sussex Sweet Taste Preference Score Change (0 to 100 where higher score indicates greater liking of sweet taste) |
| Measure | Description | Time Frame |
|---|---|---|
| Waist Circumference Change | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| Sussex Sweet Taste Preference Score Change (0 to 100 where higher score indicates greater liking of sweet taste) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deirdre Tobias, ScD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Parallel randomization on a rolling basis to one of 4 interventions; After 9/1/2023 design is modified to 3 parallel interventions, with sucralose and aspartame interventions combined into one ASB substitution arm
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Outcomes assessor will be blinded to participants' beverage assignment at time of outcome assessment; Investigators will be masked to treatment arm assignments during primary analyses
| Experimental |
Instruction/guidelines to eliminate SSBs and replace, where possible with beverages artificially sweetened with choice of non-nutritive sweeteners such as sucralose or aspartame |
|
| Substitute to non-SSBs | Behavioral | Instruction/guidelines to eliminate SSBs and replace, where possible, with beverages consistent to group assignment (months 0-6); then switch to water only (months 6-12) |
|
| Study app | Behavioral | Engage with a motivational mobile app to track beverage intake and complete study data collection |
|
| Beverage delivery | Behavioral | Select from approved beverages for a monthly at-home delivery (months 0-6) |
|
Calculated as month 6 minus baseline value
| Baseline, Month 6 |
| Beverage Intake Change (oz/d) | Calculated as month 6 minus baseline value | Baseline, Month 6 |
| Fasting Plasma Glucose Change | Calculated as month 6 minus baseline value | Baseline, Month 6 |
| Fasting Blood Insulin Change | Calculated as month 6 minus baseline value | Baseline, Month 6 |
| HOMA-IR Change | Calculated as month 6 minus baseline value | Baseline, Month 6 |
| HbA1c Change | Calculated as month 6 minus baseline value | Baseline, Month 6 |
| TG/HDL Ratio Change | Calculated as month 6 minus baseline value | Baseline, Month 6 |
| Weight Change Sustainability | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6 |
Calculated as month 6 minus baseline value, month 12 minus month 6 value
| Baseline, Month 6, Month 12 |
| Total Beverage Intake Change (oz/d) | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| SSB Beverage Intake Change (oz/d) | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| ASB Beverage Intake Change (oz/d) | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| Water Intake Change (oz/d) | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| HOMA-IR Change | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| Fasting Blood Insulin Change | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| Fasting Plasma Glucose Change | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| HbA1c Change | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| Triglycerides Change | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| TG/HDL Change | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| HDL-C Change | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| LDL-C Change | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| Blood Pressure (Systolic and Diastolic) Change | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| hsCRP Change | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| Interleukin-6 Change | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| Alternative Healthy Eating Index 2015 Diet Score Change (Scale 0 to 100 with higher score indicating greater adherence to the dietary pattern) | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| Self-Reported Added Sugar Change (g/d from 24 hour diet recall) | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| Self Reported Added Sugar Change (%kcal/d from 24 hour diet recall) | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| Sweets/Desserts Change (serv/d from 24 hour diet recall) | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| Total Physical Activity Change (MET-hrs/wk) | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |
| Energy Compensation (kcal/d) Estimated from Repeated Body Weights (Assessed via At-Home Scale) vs. Repeated Energy Intake (Derived from Repeated Self-Reported 24-Hour Diet Recalls) | Calculated as month 6 minus baseline value, month 12 minus month 6 value | Baseline, Month 6, Month 12 |