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

NCT06184737 | Active Not Recruiting

• 1 other identifier: 22130
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Habit; Sugar-Sweetened Beverages

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

Study Arms (2)

iSIPsmarter

EXPERIMENTAL

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

Patient Education (PE)

ACTIVE COMPARATOR

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)

Interventions

iSIPsmarter BEHAVIORAL

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.

iSIPsmarter

Patient Education (PE) BEHAVIORAL

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.

Patient Education (PE)

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• University of North Carolina: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908-0717, United States

Location

MeSH Terms

Conditions

Feeding Behavior; Body Weight

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jamie M Zoellner, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Lee Ritterband, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Community Based Health Equity Program

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: January 12, 2024
• Primary Completion: October 24, 2024
• Study Completion: March 17, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)