Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06184737

iSIPsmarter: A Pilot RCT to Evaluate a Web-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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diet Habit Behavior Behavior, Animal Body Weight Feeding Behavior Pathological Conditions, Signs and Symptoms Signs and Symptoms Sugar-Sweetened Beverages

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22908-0717, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change from baseline sugar-sweetened beverage at 9-weeks

    Time frame: Baseline, 9-weeks (immediate-post follow-up)

    Measured using the Beverage Questionnaire 15 (BEVQ-15)

Secondary outcomes

  1. Change from baseline dietary quality as measured by the components of the Healthy Eating Index (HEI) at 9-weeks, 6-months and 18 months

    Time frame: Baseline, 9-weeks (immediate-post follow-up), 6-months, 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).

  2. Change from baseline weight at 9-weeks, 6-months and 18 months

    Time frame: Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months

    Cellular enabled in-home ©BodyTrace digital scale

  3. Change from baseline overall quality of life at 9-weeks, 6-months and 18 months

    Time frame: Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months

    Using the Center's for Disease (CDC) Healthy Days Core Module

  4. Change from baseline sugar-sweetened beverage at 6-months and 18 months

    Time frame: Baseline, 6-months, 18 months

    Measured using the BEVQ-15

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • University of North Carolina

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Dec 28, 2023
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.