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Behavioural Intervention
iSIPsmarter for Sugary Drinks
N/A
Recruiting
Led By Lee Ritterband, PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months
Awards & highlights
Study Summary
This trial will enroll 24 Black adults to compare the effectiveness of a new program called iSIPsmarter with a static Patient Education (PE) website. The trial will assess the participants at four
Who is the study for?
This trial is for Black adults interested in reducing their sugary drink intake. Specific eligibility details are not provided, but typically participants would need to be willing to follow the intervention and attend follow-up assessments.Check my eligibility
What is being tested?
The study is testing iSIPsmarter, a technology-based behavioral intervention, against a standard patient education website. Participants will be randomly assigned to one of these two groups and followed over an 18-month period to compare effectiveness.See study design
What are the potential side effects?
Since this trial involves behavioral interventions focused on education and habit change rather than medication or medical procedures, significant side effects are not expected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline sugar-sweetened beverage at 9-weeks
Secondary outcome measures
Change from baseline dietary quality as measured by the components of the Healthy Eating Index (HEI) at 9-weeks, 6-months and 18 months
Change from baseline overall quality of life at 9-weeks, 6-months and 18 months
Change from baseline sugar-sweetened beverage at 6-months and 18 months
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: iSIPsmarterExperimental Treatment1 Intervention
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.
Group II: Patient Education (PE)Active Control1 Intervention
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.
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Who is running the clinical trial?
University of North CarolinaOTHER
168 Previous Clinical Trials
1,450,298 Total Patients Enrolled
University of VirginiaLead Sponsor
755 Previous Clinical Trials
1,245,267 Total Patients Enrolled
Lee Ritterband, PhDPrincipal InvestigatorUniversity of Virginia
1 Previous Clinical Trials
245 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Which group of individuals would be the most suitable candidates to participate in this clinical study?
"To be eligible for participation in this research study, candidates should have a regular intake of sugary beverages and fall within the age range of 18 to 110 years. The trial aims to recruit approximately 24 individuals."
Answered by AI
Is the enrollment for this research study currently open?
"Based on the information provided by clinicaltrials.gov, recruitment for this specific clinical trial is currently closed. The trial was initially posted on January 15th, 2024 and underwent its last update on December 14th, 2023. While this study is not actively seeking participants, it's worth noting that there are presently 29 other trials accepting enrolments."
Answered by AI
Is the age criterion for participating in this study limited to individuals below 70 years of age?
"To be eligible for this trial, individuals need to fall within the age range of 18 and above up to 110. It is important to note that there are separate clinical trials available specifically for participants under the age of 18 (2 trials) as well as those over the age of 65 (24 trials)."
Answered by AI
Who else is applying?
What site did they apply to?
University of Virginia
What portion of applicants met pre-screening criteria?
Met criteria
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