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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06184737
Other study ID # 22130
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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