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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD015033 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of North Carolina | OTHER |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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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 | 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. |
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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 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) |
| 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. |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40513952 | Derived | 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. | |
| 34492306 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 9-week |
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| 6-month post intervention |
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| 18-month post intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who completed Baseline and 9-week Bev-Q survey, were not previously lost to follow-up or withdrawn from the study, and had complete data for covariates used in the analysis (age, sex, race, income, educational level, and health literacy). | Posted | Least Squares Mean | 95% Confidence Interval | fluid milliters/day | Baseline, 9-weeks (immediate-post follow-up) |
|
Adverse events were collected through the 18-month follow-up data collection
Given the low risk nature of the sugary beverage intervention, adverse events and/or serious adverse events were determined in a non-systematic method, including self-reporting by participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Zoellner | Univeristy of Virginia | 434-962-4488 | jz9q@virginia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 25, 2022 | Sep 5, 2025 | Prot_SAP_000.pdf |
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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 | 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. |
|
| 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) |
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| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Annual Household Income | Count of Participants | Participants |
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| Education Level, categorical | Count of Participants | Participants |
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| Perceived Health Literacy, continuous | 3 single-item subjective rating of Health literacy reported on a 5-point Likert scale and summed to create a total score ranging from 0 to 12. Questions include confidence in completing medical forms on their own, needing help with written medical instructions and other materials, and overall reading abilty. Higher scores indicate higher levels of health literacy. | Mean | Standard Deviation | units on a scale |
|
| Rurality Status, categorical | Determined by county level Rural Urban Continuum Codes (RUCC). Ranges from 1-9 with higher scores indicating greater rurality. For the study, the RUCC codes were broken down into three categories: 1-2=large to medium metro areas, 3=small metro areas with overlapping rural and urban characteristics, and 4-9=non metro or rural areas. | Count of Participants | Participants |
|
| Weight, continuous | Weight obtained during enrollment via a cellular enabled BodyTrace scale. Weight was retrieved by researchers via the BodyTrace online interface. | 10 participants were excluded from analysis due to missing weight data (n=1), defective scales (n=4), pregnancy (n=2), bariatric surgery (n=1), and exceeding the scales maximum weight (n=2) | Mean | Standard Deviation | kilograms |
|
| BMI, continuous | 10 participants were excluded from analysis due to missing weight data (n=1), defective scales (n=4), pregnancy (n=2), bariatric surgery (n=1), and exceeding the scales maximum weight (n=2) | Mean | Standard Deviation | kg/m^2 |
|
| BMI, categorical | BMI categorized according to the CDC guidelines: <=18.4=underweight, 18.5-24.9=normal weight, 25-29.9=overweight, 30-34.9=obesity I, 35-39.9=obestity II, >=40=obesity III. | 10 participants were excluded from analysis due to missing weight data (n=1), defective scales (n=4), pregnancy (n=2), bariatric surgery (n=1), and exceeding the scales maximum weight (n=2) | Count of Participants | Participants |
|
| Sugar-sweetened beverage fluid milliliters/day | 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 daily intake of all SSB. | Mean | Standard Deviation | fluid milliliters/day |
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| Sugary-sweetened beverage kilocalories/day | The primary sugar-sweetened beverage (SSB) outcome was assessed with the BEVQ-15, which queries past 30 day intake. 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 daily intake of all SSB. Standardized kilocaloried information for the drink categories were used to determine estimates of daily SSB kcal. | Mean | Standard Deviation | kilocalories/day |
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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. 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. |
| OG001 | 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. 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. |
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| Secondary | 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. | Participants who completed the Bev-Q at 6-months, were not previously lost to follow-up or withdrawn from the study, and had complete data for covariates used in the analysis (age, sex, race, income, educational level, and health literacy). | Posted | Least Squares Mean | 95% Confidence Interval | fluid milliters/day | Baseline, 6-months (post-intervention follow-up) |
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| Secondary | 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. | Participants who completed the Bev-Q at 18-months, were not previously lost to follow-up or withdrawn from the study, and had complete data for covariates used in the analysis (age, sex, race, income, educational level, and health literacy). | Posted | Least Squares Mean | 95% Confidence Interval | fluid milliters/day | Baseline, 18-months (post itnervention follow-up) |
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| Secondary | 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). | Participants who weighed themselves on the BodyTrace scale, did not have an excluded weight (e.g., pregnancy, defective scale, bariatric surgery, weight exceed scale limit), were not lost to follow-up or withdrawn from the study, and had complete data for covariates used in the analysis (age, sex, race, income, educational level, and health literacy). | Posted | Least Squares Mean | 95% Confidence Interval | percent weight change | Baseline, 9-weeks (immediate-post follow-up) |
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| Secondary | 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). | Participants who weighed themselves on the BodyTrace scale, did not have an excluded weight (e.g., pregnancy, defective scale, bariatric surgery, weight exceed scale limit), were not lost to follow-up or withdrawn from the study, and had complete data for covariates used in the analysis (age, sex, race, income, educational level, and health literacy). | Posted | Least Squares Mean | 95% Confidence Interval | percent weight change | Baseline, 6-months (post-intervention follow-up) |
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| Secondary | 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). | Participants who weighed themselves on the BodyTrace scale, did not have an excluded weight (e.g., pregnancy, defective scale, bariatric surgery, weight exceed scale limit), were not lost to follow-up or withdrawn from the study, and had complete data for covariates used in the analysis (age, sex, race, income, educational level, and health literacy). | Posted | Least Squares Mean | 95% Confidence Interval | percent weight change | Baseline, 18-months (post-intervention follow-up) |
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| Secondary | 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. | Participants who completed the Healthy Days scale, were not lost to follow-up or withdrawn from the study, and had complete data for covariates used in the analysis (age, sex, race, income, educational level, and health literacy). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, 9-weeks (immediate post-folllow-up) |
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| Secondary | 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. | Participants who completed the Healthy Days scale, were not lost to follow-up or withdrawn from the study, and had complete data for covariates used in the analysis (age, sex, race, income, educational level, and health literacy). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, 6-months (post intervention follow-up) |
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| Secondary | 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. | Participants who completed the Healthy Days scale, were not lost to follow-up or withdrawn from the study, and had complete data for covariates used in the analysis (age, sex, race, income, educational level, and health literacy). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, 18-months (post intervention follow-up) |
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| Secondary | 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). | Participants who completed dietary recalls at all time points (Baseline, 9-weeks, 6-months, and 18 months). | Posted | Least Squares Mean | 95% Confidence Interval | score on scale | Baseline, 9-weeks (immediate-post follow-up) |
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| Secondary | 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). | Participants who completed dietary recalls at all time points (Baseline, 9-weeks, 6-months, and 18 months). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, 6-months (post intervention follow-up) |
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| Secondary | 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). | Participants who completed dietary recalls at all time points (Baseline, 9-weeks, 6-months, and 18 months). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, 18-months (post intervention follow-up) |
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|
| 0 |
| 127 |
| 0 |
| 127 |
| 0 |
| 127 |
| EG001 | 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. 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. | 0 | 122 | 0 | 122 | 0 | 122 |
Not provided
Not provided
| Other |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| $35,000-$54,999 |
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| >= $55,000 |
|
| Unknown or unreported |
|
| RUCC 4-9 |
|
| Normal |
|
| Obesity Class 1 |
|
| Obesity Class 2 |
|
| Obesity Class 3 |
|