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临床试验/NCT05030753
NCT05030753已完成不适用

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

University of Virginia1 个研究点 分布在 1 个国家目标入组 249 人开始时间: 2021年8月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
249
试验地点
1
主要终点
Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 9-weeks

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

iSIPsmarter

Experimental

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.

干预措施: iSIPsmarter (Behavioral)

Patient Education (PE)

Active Comparator

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.

干预措施: Patient Education (PE) (Behavioral)

结局指标

主要结局

Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 9-weeks

时间窗: 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.

次要结局

  • Percent Weight Change From Baseline Weight at 18-months(Baseline, 18-months (post-intervention follow-up))
  • Change From Baseline Overall Quality of Life at 18-months(Baseline, 18-months (post intervention follow-up))
  • Change From Baseline Dietary Quality as Measured by the Healthy Eating Index (HEI) Score at 9-weeks(Baseline, 9-weeks (immediate-post follow-up))
  • Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 6-months Post Intervention(Baseline, 6-months (post-intervention follow-up))
  • Change From Baseline Overall Quality of Life at 9-weeks(Baseline, 9-weeks (immediate post-folllow-up))
  • Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 18-months Post Intervention(Baseline, 18-months (post itnervention follow-up))
  • Percent Weight Change From Baseline Weight at 9-weeks(Baseline, 9-weeks (immediate-post follow-up))
  • Percent Weight Change From Baseline Weight at 6-months(Baseline, 6-months (post-intervention follow-up))
  • Change From Baseline Overall Quality of Life at 6-months(Baseline, 6-months (post intervention follow-up))
  • Change From Baseline Dietary Quality as Measured by the Healthy Eating Index (HEI) Score at 6-months(Baseline, 6-months (post intervention follow-up))
  • Change From Baseline Dietary Quality as Measured the Healthy Eating Index (HEI) Score at 18 Months(Baseline, 18-months (post intervention follow-up))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamie Zoellner, PhD RD

Director, Community Based Health Equity Program

University of Virginia

研究点 (1)

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