Web-Based Intervention for Reducing Sugary Drinks

Overseen By Lee Ritterband, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Non-English, Non-Black, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 9 weeks

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment iSIPsmarter, SIPsmartER, and Patient Education (PE) for reducing sugary drink intake?

Research shows that SIPsmartER, a part of the treatment, effectively reduces sugary drink intake among adults in rural areas by using a combination of group classes, phone calls, and personal action plans. Participants reported high satisfaction with the program, and significant reductions in sugary drink consumption were observed. ^{1 2 3 4 5}

Is the SIPsmartER intervention safe for humans?

The available research on SIPsmartER, a program aimed at reducing sugary drink intake, does not report any safety concerns for participants. It has been implemented in various community settings without noted adverse effects. ^{1 2 6 7 8}

How is the iSIPsmarter treatment different from other treatments for reducing sugary drink intake?

The iSIPsmarter treatment is unique because it is a web-based intervention that combines in-person group classes, teach-back calls, and automated phone calls to help reduce sugary drink intake, making it accessible and scalable for rural communities. ^{1 2 7 9 10}

What is the purpose of this trial?

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.

Research Team

Jamie M Zoellner, PhD

Principal Investigator

University of Virginia

Lee Ritterband, PhD

Principal Investigator

University of Virginia

Eligibility Criteria

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.

Inclusion Criteria

I am an adult over 18, identify as Black, drink sugary drinks daily, can use the internet weekly, and am okay with SMS reminders.

Exclusion Criteria

Do not identify as Black

Consume <200 kcals of SSB/day

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with the iSIPsmarter or PE website intervention, including self-monitoring and behavior change strategies

9 weeks

Online engagement and self-monitoring

Follow-up

Participants are monitored for changes in sugar-sweetened beverage consumption, dietary quality, quality of life, and weight

18 months

Assessments at 3, 6, and 18 months

Treatment Details

Interventions

• iSIPsmarter
• Patient Education (PE)

Trial Overview 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.

Participant Groups

Group I: iSIPsmarter Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

Findings from Research

The SIPsmartER intervention, implemented over 6 months in rural Virginia, significantly reduced sugar-sweetened beverage consumption by an average of 403 kcal/day, indicating its effectiveness in improving dietary behaviors among participants.

Participants also showed significant improvements in attitudes, perceived control, and intentions related to sugar-sweetened beverages, suggesting that SIPsmartER not only impacts consumption but also enhances health literacy and motivation to make healthier choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The reach and effectiveness of SIPsmartER when implemented by rural public health departments: a pilot dissemination and implementation trial to reduce sugar-sweetened beverages. Zoellner, JM., Porter, KJ., You, W., et al.[2022]

The SIPsmartER intervention, aimed at reducing sugar-sweetened beverage consumption, was successfully implemented in rural Appalachian Virginia with high fidelity, achieving 86% of expected small group classes and 89% cohort recruitment.

Delivery agents found the in-person classes and implementation strategies to be acceptable and feasible, although challenges were noted in completing teach-back and missed class calls, indicating areas for improvement in future implementations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SIPsmartER delivered through rural, local health districts: adoption and implementation outcomes. Porter, KJ., Brock, DJ., Estabrooks, PA., et al.[2020]

The SIPsmartER intervention, which lasted 6 months and involved 155 participants, effectively reduced sugary beverage intake among rural, low socioeconomic adults, with high satisfaction ratings across all components of the program.

Participants with varying health literacy levels reported similar satisfaction with the intervention, indicating that a health literacy universal precautions approach is effective and acceptable for both high and low health literacy groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of health literacy on rural adults' satisfaction with a multi-component intervention to reduce sugar-sweetened beverage intake. Bailey, AN., Porter, KJ., Hill, JL., et al.[2019]

A study involving 16 individuals with diabetes showed that computer-based meal planning and diet education significantly improved knowledge about diabetes nutrition and reduced fat intake after 4 weeks.

Participants also experienced an average weight loss of 4.6 pounds, indicating that computer-assisted education can effectively supplement traditional diet counseling without requiring much additional time from dietitians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of computer-based diet education in persons with diabetes mellitus and limited educational background. Wheeler, LA., Wheeler, ML., Ours, P., et al.[2019]

A study involving 228 pediatric and family medicine clinic staff showed that training improved their knowledge about sugar-sweetened beverages and increased the acceptability of using a screener in electronic health records.

After implementing the screener, 47% of eligible pediatric patients were screened within 6 months, indicating that engaging healthcare staff in screening for sugary beverage consumption is feasible and can help address children's health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staff Knowledge, Attitudes, and Beliefs About Child Sugar-Sweetened Beverage Intake and Acceptability of a Pediatric Clinic-Based Beverage Screener. Howell, BL., Skelton, JA., Jayaprakash, MS., et al.[2023]

Participants in the SIPsmartER intervention significantly reduced their intake of sugar-sweetened beverages (SSBs) by an average of 366 mL over 6 months, which was associated with improvements in overall dietary quality as measured by the Healthy Eating Index (HEI).

The SIPsmartER group also experienced reductions in total energy intake, trans fats, and added sugars, indicating that targeting SSB reduction can lead to broader positive dietary changes, unlike the MoveMore group, which showed minimal dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary quality changes in response to a sugar-sweetened beverage-reduction intervention: results from the Talking Health randomized controlled clinical trial. Hedrick, VE., Davy, BM., You, W., et al.[2023]

In a study of 155 rural participants in the SIPsmartER intervention, greater attendance in classes was linked to a significant reduction in sugar-sweetened beverage (SSB) intake, highlighting the importance of engagement in behavioral interventions.

Baseline characteristics, such as age and initial SSB intake, were found to influence both engagement and outcomes, suggesting that tailored approaches may enhance the effectiveness of similar community-based health programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of engagement and outcome achievement in a behavioural intervention targeting sugar-sweetened beverage intake among rural adults. Porter, KJ., Thomson, JL., Zoellner, JM.[2023]

A study evaluated 4 DASH (Dietary Approaches to Stop Hypertension) apps, finding that only one paid app scored high in quality, while the free apps generally had lower quality ratings.

The research highlights the need for better development of free DASH apps, as the current options may not effectively support users in managing hypertension through diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Apps for the Dietary Approaches to Stop Hypertension (DASH): App Quality Evaluation. DiFilippo, KN., Huang, WD., Chapman-Novakofski, KM.[2020]

Both interactive and print-delivered computer-tailored nutrition education significantly reduced total and saturated fat intake among 442 healthy Dutch adults, with effects lasting up to 6 months for the print-delivered intervention.

Participants with initially high fat intakes benefited the most from the tailored interventions, showing that personalized feedback can effectively promote healthier eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of Web-based and print-delivered computer-tailored interventions to reduce fat intake: results of a randomized, controlled trial. Kroeze, W., Oenema, A., Campbell, M., et al.[2013]

A pilot study involving 60 parent-child dyads showed that a technology-driven intervention to reduce sugary beverage intake was well-accepted and feasible, but did not lead to significant differences in consumption between the intervention and control groups after 6 months.

While parents in the intervention group initially reduced their children's sugary beverage intake more than those in the control group at 3 months, this effect was not maintained at 6 months, suggesting that simpler interventions like electronic health record-based screening may be sufficient for achieving similar outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Technology-Driven, Healthcare-Based Intervention to Improve Family Beverage Choices: Results from a Pilot Randomized Trial in the United States. Lewis, KH., Hsu, FC., Block, JP., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

The reach and effectiveness of SIPsmartER when implemented by rural public health departments: a pilot dissemination and implementation trial to reduce sugar-sweetened beverages. [2022]

2. England pubmed.ncbi.nlm.nih.gov

SIPsmartER delivered through rural, local health districts: adoption and implementation outcomes. [2020]

3. England pubmed.ncbi.nlm.nih.gov

The impact of health literacy on rural adults' satisfaction with a multi-component intervention to reduce sugar-sweetened beverage intake. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of computer-based diet education in persons with diabetes mellitus and limited educational background. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Staff Knowledge, Attitudes, and Beliefs About Child Sugar-Sweetened Beverage Intake and Acceptability of a Pediatric Clinic-Based Beverage Screener. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Dietary quality changes in response to a sugar-sweetened beverage-reduction intervention: results from the Talking Health randomized controlled clinical trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Predictors of engagement and outcome achievement in a behavioural intervention targeting sugar-sweetened beverage intake among rural adults. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Mobile Apps for the Dietary Approaches to Stop Hypertension (DASH): App Quality Evaluation. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

The efficacy of Web-based and print-delivered computer-tailored interventions to reduce fat intake: results of a randomized, controlled trial. [2013]

10. Switzerland pubmed.ncbi.nlm.nih.gov

A Technology-Driven, Healthcare-Based Intervention to Improve Family Beverage Choices: Results from a Pilot Randomized Trial in the United States. [2023]