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iSIPsmarter: A Pilot RCT to Evaluate a Web-based Behavioral Intervention to Reduce Sugary Beverages Among Black Adults

iSIPsmarter: A Pilot RCT to Evaluate a Technology-based Behavioral Intervention to Reduce Sugary Beverages Among Black Adults

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06184737
Enrollment
24
Registered
2023-12-28
Start date
2024-01-12
Completion date
2026-03-17
Last updated
2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet Habit, Sugar-Sweetened Beverages

Keywords

sugar-sweetened beverages, weight, health disparities, self-monitoring, internet intervention, e/m health, text messaging

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.

Interventions

BEHAVIORALiSIPsmarter

iSIPsmarter is a technology-based behavioral and health literacy intervention. It is comprised of six Internet-delivered Cores, an integrated short message service (SMS) strategy to engage users in tracking SSB behaviors, and the incorporation of a cellular enabled scale for in-home weight tracking. Participants will be prompted (via email or text) to self-monitor their sugar-sweetened beverage intake. iSIPsmarter is a highly interactive, structured, and self-guided program that uses strategies previously proven to promote behavior change. iSIPsmarter also incorporates a stepped care approach to re-engage users who struggle to complete components.

The PE website will include scientifically accurate information that is typical of nutrition education websites and will include information about SSB recommendations, types of SSB and portion size, SSB-related health risks, energy balance information, identifying personal motivators and barriers to reducing SSB intake, interpreting SSB nutrition labels, and recognizing media influences and misclaims in SSB advertisements, as well as printable forms to track SSB and weight. Unlike iSIPsmarter, the content will not be tailored and will be presented all at once.

Sponsors

University of North Carolina
CollaboratorOTHER
University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline sugar-sweetened beverage at 9-weeksBaseline, 9-weeks (immediate-post follow-up)Measured using the Beverage Questionnaire 15 (BEVQ-15)

Secondary

MeasureTime frameDescription
Change from baseline dietary quality as measured by the components of the Healthy Eating Index (HEI) at 9-weeks, 6-months and 18 monthsBaseline, 9-weeks (immediate-post follow-up), 6-months, 18 months2 unannounced recalls (one weekend and one weekday) using state-of-the-art Nutrition Data System for Research (NDSR) software and multiple pass methods. HEI indicators will be extracted from the NDSR system and examined for changes in the total HEI score, on a 100-point continuous scale (higher scores reflective higher diet quality).
Change from baseline weight at 9-weeks, 6-months and 18 monthsBaseline, 9-weeks (immediate-post follow-up), 6-months, 18 monthsCellular enabled in-home ©BodyTrace digital scale
Change from baseline overall quality of life at 9-weeks, 6-months and 18 monthsBaseline, 9-weeks (immediate-post follow-up), 6-months, 18 monthsUsing the Center's for Disease (CDC) Healthy Days Core Module
Change from baseline sugar-sweetened beverage at 6-months and 18 monthsBaseline, 6-months, 18 monthsMeasured using the BEVQ-15

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026