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

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: Completed
• Conditions: Diet Habit; Sugar-Sweetened Beverages
• Intervention / Treatment: Behavioral: iSIPsmarter; Behavioral: Patient Education (PE)

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: Interventional
• Enrollment (Actual): 249
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 9-weeks	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

Outcome Measure	Measure Description	Time Frame
Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 6-months Post Intervention	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: University of Virginia
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); University of North Carolina
• Investigators: Principal Investigator: Jamie M Zoellner, PhD, University of Virginia; Principal Investigator: Lee Ritterband, PhD, University of Virginia

Publications and helpful links

General Publications

• Zoellner JM, Porter KJ, You W, Reid AL, Frederick C, Hilgart M, Brock DP, Tate DF, Ritterband LM. Study protocol for iSIPsmarter: A randomized-controlled trial to evaluate the efficacy, reach, and engagement of a technology-based behavioral intervention to reduce sugary beverages among rural Appalachian adults. Contemp Clin Trials. 2021 Nov;110:106566. doi: 10.1016/j.cct.2021.106566. Epub 2021 Sep 4.
• Zoellner JM, You W, Porter K, Reid AL, Brock DP, Markwalter T, Frederick C, Tate DF, Ritterband L. A digital behavioral intervention to reduce sugar-sweetened beverage consumption: a randomized, controlled trial. Am J Clin Nutr. 2025 Aug;122(2):544-555. doi: 10.1016/j.ajcnut.2025.06.010. Epub 2025 Jun 11.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): August 23, 2024

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: sugar-sweetened beverages; self-monitoring; rural; health disparities; weight; internet intervention; e/m health; test messaging
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Behavior, Animal; Body Weight; Feeding Behavior; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Health Education; Patient Education as Topic
• Other Study ID 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