iSIPsmarter: An RCT Evaluating the Efficacy of a Technology-Based Intervention to Reduce Sugary Drinks in Rural Appalachia

September 25, 2025 updated by: Jamie Zoellner, PhD RD, University of Virginia

iSIPsmarter: An RCT to Evaluate the Efficacy, Reach, and Engagement of a Technology-based Behavioral and Health Literacy Intervention to Reduce Sugary Beverages Among Rural Appalachian Adults

The proposed randomized controlled trial (RCT) is guided by the RE-AIM (i.e. reach, efficacy, adoption, implementation, maintenance) framework and targets 244 adults from rural Appalachia. The overall goal is to examine the 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. It is hypothesized that iSIPsmarter will be more efficacious at reducing SSB consumption than a PE website at post assessment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sugar-sweetened beverages (SSB, e.g., soda/pop, sweet tea, sports and energy drinks, fruit drinks) are the largest single food source of calories in the United States (US) diet and contributes approximately 7% of total daily energy intake for US adults. Among Appalachian adults, SSB intake is disproportionately high, averaging about 14% of total daily energy intake. There are strong and consistent data documenting relationships among high SSB consumption and numerous health issues such obesity, diabetes, some obesity-related cancers, coronary heart disease, hypertension, and dental decay. Further compounding the SSB problem, the Appalachian region lacks access to providers, medical services, and evidence-based behavioral prevention programs. There is also limited data on technology-based behavioral interventions in Appalachia. However, given recent progress in shrinking the digital divide, the timing is optimal to evaluate technology-based behavioral interventions in this region. The current proposal is designed to target this major SSB dietary risk factor and public health challenge, as well as address notable gaps in the rural e/m-Health literature. Importantly, this proposal builds on our team's e/m-Health intervention expertise and decade of SSB behavioral intervention research in rural Appalachia. iSIPsmarter is a technology-based behavioral and health literacy intervention targeting SSB reduction and weight reduction/maintenance. It is comprised of six core Internet-delivered modules, an integrated short message service (SMS) strategy to engage users in tracking SSB behaviors, and a cellular enabled scale for in-home weight tracking. 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 engage users who struggle to complete components of the intervention. The proposed RCT is guided by the RE-AIM framework and targets 244 adults from rural Appalachia. The overall goal is to examine the 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. It is hypothesized that iSIPsmarter will be more efficacious at reducing SSB consumption than a PE website at post assessment. Changes in secondary outcomes (e.g. overall dietary quality, weight, quality of life) and maintenance of outcomes at 6- and 18-months post intervention will also be evaluated. Additional secondary aims include to examine reach and representativeness, patterns of user engagement, and cost. Two tertiary aims include exploratory mediation analyses and a systems-level, participatory process to understand context for future organizational-level adoption of iSIPsmarter, and specifically to explore factors that would promote or inhibit a sustainable SSB screening and referral process. The long-term goal of this line of this research is to sustain an effective, scalable, and high reach behavioral intervention to improve SSB behaviors and weight and to reduce SSB-related health inequities and chronic conditions in rural Appalachia and beyond.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
249

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • English speaking adults, > 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, <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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
he 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)
he 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 9-weeks
Time Frame: Baseline, 9-weeks (immediate-post follow-up)
The primary sugar sweetened beverage (SSB) outcome was assessed with the BEVQ-15, which queries intake over the past 30 days. Using standardized and validated scoring procedures, totals for the five SSB-related beverages (i.e., regular soft drinks, sweetened juice beverage/drink, sweetened tea, coffee with sugar, energy/sports drinks) were determined by multiplying reported intake frequency by portion size, and then summing the five categories to obtain total fluid milliters/day intake of all SSB.
Baseline, 9-weeks (immediate-post follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 6-months Post Intervention
Time Frame: Baseline, 6-months (post-intervention follow-up)
The primary sugar sweetened beverage (SSB) outcome was assessed with the BEVQ-15, which queries intake over the past 30 days. Using standardized and validated scoring procedures, totals for the five SSB-related beverages (i.e., regular soft drinks, sweetened juice beverage/drink, sweetened tea, coffee with sugar, energy/sports drinks) were determined by multiplying reported intake frequency by portion size, and then summing the five categories to obtain total fluid milliters/day intake of all SSB.
Baseline, 6-months (post-intervention follow-up)
Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 18-months Post Intervention
Time Frame: Baseline, 18-months (post itnervention follow-up)
The primary sugar sweetened beverage (SSB) outcome was assessed with the BEVQ-15, which queries intake over the past 30 days. Using standardized and validated scoring procedures, totals for the five SSB-related beverages (i.e., regular soft drinks, sweetened juice beverage/drink, sweetened tea, coffee with sugar, energy/sports drinks) were determined by multiplying reported intake frequency by portion size, and then summing the five categories to obtain total fluid milliters/day of all SSB.
Baseline, 18-months (post itnervention follow-up)
Percent Weight Change From Baseline Weight at 9-weeks
Time Frame: Baseline, 9-weeks (immediate-post follow-up)
Using weight data collected from a cellular enabled in-home ©BodyTrace digital scale and calculating percent weight change between Baseline and 9-weeks (immediate post follow-up).
Baseline, 9-weeks (immediate-post follow-up)
Percent Weight Change From Baseline Weight at 6-months
Time Frame: Baseline, 6-months (post-intervention follow-up)
Using weight data collected from a cellular enabled in-home ©BodyTrace digital scale and calculating percent weight change between Baseline and 6-months (post intervention follow-up).
Baseline, 6-months (post-intervention follow-up)
Percent Weight Change From Baseline Weight at 18-months
Time Frame: Baseline, 18-months (post-intervention follow-up)
Using weight data collected from a cellular enabled in-home ©BodyTrace digital scale and calculating percent weight change between Baseline and 6-months (post intervention follow-up).
Baseline, 18-months (post-intervention follow-up)
Change From Baseline Overall Quality of Life at 9-weeks
Time Frame: Baseline, 9-weeks (immediate post-folllow-up)
Using the Center's for Disease (CDC) Healthy Days Core Module to measure total days in the past month that were either physically or mentally unhealth. Range is from 0-30. Lower scores indicate greater quality of life.
Baseline, 9-weeks (immediate post-folllow-up)
Change From Baseline Overall Quality of Life at 6-months
Time Frame: Baseline, 6-months (post intervention follow-up)
Using the Center's for Disease (CDC) Healthy Days Core Module to measure total days in the past month that were either physically or mentally unhealth. Range is from 0-30. Lower scores indicate greater quality of life.
Baseline, 6-months (post intervention follow-up)
Change From Baseline Overall Quality of Life at 18-months
Time Frame: Baseline, 18-months (post intervention follow-up)
Using the Center's for Disease (CDC) Healthy Days Core Module to measure total days in the past month that were either physically or mentally unhealth. Range is from 0-30. Lower scores indicate greater quality of life.
Baseline, 18-months (post intervention follow-up)
Change From Baseline Dietary Quality as Measured by the Healthy Eating Index (HEI) Score at 9-weeks
Time Frame: Baseline, 9-weeks (immediate-post follow-up)
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)
Change From Baseline Dietary Quality as Measured by the Healthy Eating Index (HEI) Score at 6-months
Time Frame: Baseline, 6-months (post intervention follow-up)
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, 6-months (post intervention follow-up)
Change From Baseline Dietary Quality as Measured the Healthy Eating Index (HEI) Score at 18 Months
Time Frame: Baseline, 18-months (post intervention follow-up)
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, 18-months (post intervention follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)
University of North Carolina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jamie M Zoellner, PhD, University of Virginia
  • Principal Investigator: Lee Ritterband, PhD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • University of Virginia (Other Grant/Funding Number: University of Virginia)
  • R01MD015033 (U.S. NIH Grant/Contract)

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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