Clinical trial NCT05030753: iSIPsmarter: An RCT to Evaluate the Efficacy of a Technology-based Behavioral Intervention to Reduce Sugary Beverages Among Rural Appalachian Adults
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Habit
Sugar-Sweetened Beverages
Keywords: sugar-sweetened beverages
weight
rural
health disparities
self-monitoring
internet intervention
e/m health
test messaging
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: University of North Carolina
First posted: 2021-09-01
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline sugar-sweetened beverage at 9-weeks
timeFrame: Baseline, 9-weeks (immediate-post follow-up)
Secondary outcomes:
measure: Change from baseline overall dietary quality at 9-weeks, 6-months and 18 months
timeFrame: Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months
measure: Change from baseline weight at 9-weeks, 6-months and 18 months
timeFrame: Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months
measure: Change from baseline overall quality of life at 9-weeks, 6-months and 18 months
timeFrame: Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months
measure: Change from baseline sugar-sweetened beverage at 6-months and 18 months
timeFrame: Baseline, 6-months, 18 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Jamie M Zoellner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Lee Ritterband, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.