N/A
N=249
iSIPsmarter: An RCT Evaluating the Efficacy of a Technology-Based Intervention to Reduce Sugary Drinks in Rural Appalachia
Diet Habit · Sugar-Sweetened Beverages
Bottom Line
View on ClinicalTrials.gov: NCT05030753 ↗Enrolled (actual)
249
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 9-weeks — -897.0; -291.0 fluid milliters/day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- iSIPsmarter (Behavioral); Patient Education (PE) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 9-weeks |
-897.0; -291.0 | — |
| SECONDARY Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 6-months Post Intervention |
-858.2; -279.5 | — |
| SECONDARY Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 18-months Post Intervention |
-893.1; -618.7 | — |
| SECONDARY Percent Weight Change From Baseline Weight at 9-weeks |
-1.13; -0.05 | — |
| SECONDARY Percent Weight Change From Baseline Weight at 6-months |
-1.95; -0.55 | — |
| SECONDARY Percent Weight Change From Baseline Weight at 18-months |
-2.97; -0.000003 | — |
| SECONDARY Change From Baseline Overall Quality of Life at 9-weeks |
-0.61; -1.28 | — |
| SECONDARY Change From Baseline Overall Quality of Life at 6-months |
-5.08; -5.31 | — |
| SECONDARY Change From Baseline Overall Quality of Life at 18-months |
-0.71; -1.92 | — |
| SECONDARY Change From Baseline Dietary Quality as Measured by the Healthy Eating Index (HEI) Score at 9-weeks |
1.70; 2.82 | — |
| SECONDARY Change From Baseline Dietary Quality as Measured by the Healthy Eating Index (HEI) Score at 6-months |
3.33; 1.65 | — |
| SECONDARY Change From Baseline Dietary Quality as Measured the Healthy Eating Index (HEI) Score at 18 Months |
4.18; 3.21 | — |
Summary
The proposed randomized controlled trial (RCT) is guided by the RE-AIM (i.e. reach, efficacy, adoption, implementation, maintenance) framework and targets 244 adults from rural Appalachia. The overall goal is to examine the efficacy of iSIPsmarter in a 2 group [iSIPsmarter vs. static Patient Education (PE) website] by 4 assessment (Pre, 3-, 6- and 18-month follow-up) design. It is hypothesized that iSIPsmarter will be more efficacious at reducing SSB consumption than a PE website at post assessment.
Eligibility Criteria
Inclusion Criteria
- English speaking adults, > or equal to 18 years of age, consume >200 kcals of SSB/day, ability and willingness to access an internet-enabled device at least one time per week and receive SMS-based reminder prompts.
Exclusion Criteria
- non-English speaking adults, <18 years of age, consume <200 kcals of SSB/day, inability and willingness to access an internet-enabled device at least one time per week and receive SMS-based reminder prompts. Also, only one person per household is eligible to participate in the trial.
Data sourced from ClinicalTrials.gov (NCT05030753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.