Skip to main content
OpenTrials
Completed

NCT Number: NCT05030753

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

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.

Completed

Looking for future studies?

Notify Me

Key information

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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).

  11. 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).

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • University of North Carolina

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Sep 1, 2021
Registry last updated
Oct 22, 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.

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