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

Diet Habit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06184737
• Other study ID #: 22130
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: January 15, 2026

Study information

• Verified date: March 2024
• Source: University of Virginia
• Contact: Jamie M Zoellner, PhD
• Phone: 14349624488
• Email: jz9q[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: January 15, 2026
• Est. primary completion date: August 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Habit

Intervention

Behavioral:
• iSIPsmarter
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.
• Patient Education (PE)
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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	University of North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline sugar-sweetened beverage at 9-weeks	Measured using the Beverage Questionnaire 15 (BEVQ-15)	Baseline, 9-weeks (immediate-post follow-up)
Secondary	Change from baseline dietary quality as measured by the components of the Healthy Eating Index (HEI) at 9-weeks, 6-months and 18 months	2 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).	Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months
Secondary	Change from baseline weight at 9-weeks, 6-months and 18 months	Cellular enabled in-home ©BodyTrace digital scale	Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months
Secondary	Change from baseline overall quality of life at 9-weeks, 6-months and 18 months	Using the Center's for Disease (CDC) Healthy Days Core Module	Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months
Secondary	Change from baseline sugar-sweetened beverage at 6-months and 18 months	Measured using the BEVQ-15	Baseline, 6-months, 18 months