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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diet Habit; Sugar-Sweetened Beverages
• Intervention / Treatment: Behavioral: iSIPsmarter; Behavioral: Patient Education (PE)

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908-0717
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change from baseline sugar-sweetened beverage at 6-months and 18 months	Measured using the BEVQ-15	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	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

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: University of North Carolina
• Investigators: Principal Investigator: Jamie M Zoellner, PhD, University of Virginia; Principal Investigator: Lee Ritterband, PhD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2024
• Primary Completion (Actual): October 24, 2024
• Study Completion (Estimated): March 17, 2026

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: sugar-sweetened beverages; self-monitoring; text messaging; health disparities; weight; internet intervention; e/m health
• Other Study ID Numbers: 22130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No