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| Name | Class |
|---|---|
| University of North Carolina | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Patient Education (PE) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline sugar-sweetened beverage at 9-weeks | Measured using the Beverage Questionnaire 15 (BEVQ-15) | Baseline, 9-weeks (immediate-post follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline dietary quality as measured by the components of the Healthy Eating Index (HEI) at 9-weeks, 6-months and 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie M Zoellner, PhD | University of Virginia | Principal Investigator |
| Lee Ritterband, PhD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908-0717 | United States |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Patient Education (PE) | Behavioral | 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. |
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| Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months |
| Change from baseline weight at 9-weeks, 6-months and 18 months | Cellular enabled in-home ©BodyTrace digital scale | Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months |
| Change from baseline overall quality of life at 9-weeks, 6-months and 18 months | Using the Center's for Disease (CDC) Healthy Days Core Module | Baseline, 9-weeks (immediate-post follow-up), 6-months, 18 months |
| Change from baseline sugar-sweetened beverage at 6-months and 18 months | Measured using the BEVQ-15 | Baseline, 6-months, 18 months |