iSIPsmarter: A Pilot RCT to Evaluate a Technology-based Behavioral Intervention to Reduce Sugary Beverages Among Black Adults
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diet Habit
- Sponsor
- University of Virginia
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change from baseline sugar-sweetened beverage at 9-weeks
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
The proposed pilot randomized controlled trial (RCT) will enroll 24 Black adults. The overall goal is to examine the preliminary 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. The generated pilot data will allow us to better understand efficacy and engagement outcomes among Black participants. We anticipate trends that iSIPsmarter will be more efficacious at reducing SSB consumption than a PE website at post assessment.
Investigators
Jamie Zoellner, PhD RD
Director, Community Based Health Equity Program
University of Virginia
Eligibility Criteria
Inclusion Criteria
- •English speaking adults, identify as Black, \> 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, do not identify as Black, \<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
Outcomes
Primary Outcomes
Change from baseline sugar-sweetened beverage at 9-weeks
Time Frame: Baseline, 9-weeks (immediate-post follow-up)
Measured using the Beverage Questionnaire 15 (BEVQ-15)
Secondary Outcomes
- Change from baseline overall quality of life at 9-weeks, 6-months and 18 months(Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months)
- Change from baseline sugar-sweetened beverage at 6-months and 18 months(Baseline, 6-months, 18 months)
- Change from baseline dietary quality as measured by the components of the Healthy Eating Index (HEI) at 9-weeks, 6-months and 18 months(Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months)
- Change from baseline weight at 9-weeks, 6-months and 18 months(Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months)