Clinical trial NCT06184737: iSIPsmarter: A Pilot RCT to Evaluate a Web-based Behavioral Intervention to Reduce Sugary Beverages Among Black Adults
Official title: iSIPsmarter: A Pilot RCT to Evaluate a Technology-based Behavioral Intervention to Reduce Sugary Beverages Among Black Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diet Habit
Sugar-Sweetened Beverages
Keywords: sugar-sweetened beverages
weight
health disparities
self-monitoring
internet intervention
e/m health
text messaging
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: University of North Carolina
First posted: 2023-12-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change from baseline sugar-sweetened beverage at 9-weeks
timeFrame: Baseline, 9-weeks (immediate-post follow-up)
Secondary outcomes:
measure: Change from baseline dietary quality as measured by the components of the Healthy Eating Index (HEI) at 9-weeks, 6-months and 18 months
timeFrame: Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months
measure: Change from baseline weight at 9-weeks, 6-months and 18 months
timeFrame: Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months
measure: Change from baseline overall quality of life at 9-weeks, 6-months and 18 months
timeFrame: Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months
measure: Change from baseline sugar-sweetened beverage at 6-months and 18 months
timeFrame: Baseline, 6-months, 18 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Jamie M Zoellner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Lee Ritterband, PhD
role: PRINCIPAL_INVESTIGATOR
References: