Diet Habit, Sugar-Sweetened Beverages
Conditions
Keywords
sugar-sweetened beverages, weight, rural, health disparities, self-monitoring, internet intervention, e/m health, test messaging
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.
Interventions
BEHAVIORALiSIPsmarter
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.
BEHAVIORALPatient 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.
Sponsors
University of North Carolina
National Institute on Minority Health and Health Disparities (NIMHD)
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 9-weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 18-months Post Intervention | Baseline, 18-months (post itnervention 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 of all SSB. |
| Percent Weight Change From Baseline Weight at 9-weeks | Baseline, 9-weeks (immediate-post follow-up) | 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). |
| Percent Weight Change From Baseline Weight at 6-months | Baseline, 6-months (post-intervention follow-up) | 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). |
| Percent Weight Change From Baseline Weight at 18-months | Baseline, 18-months (post-intervention follow-up) | 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). |
| Change From Baseline Overall Quality of Life at 9-weeks | Baseline, 9-weeks (immediate post-folllow-up) | 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. |
| Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 6-months Post Intervention | Baseline, 6-months (post-intervention 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. |
| Change From Baseline Overall Quality of Life at 18-months | Baseline, 18-months (post intervention follow-up) | 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. |
| Change From Baseline Dietary Quality as Measured by the Healthy Eating Index (HEI) Score at 9-weeks | Baseline, 9-weeks (immediate-post follow-up) | 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). |
| Change From Baseline Dietary Quality as Measured by the Healthy Eating Index (HEI) Score at 6-months | Baseline, 6-months (post intervention follow-up) | 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). |
| Change From Baseline Dietary Quality as Measured the Healthy Eating Index (HEI) Score at 18 Months | Baseline, 18-months (post intervention follow-up) | 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). |
| Change From Baseline Overall Quality of Life at 6-months | Baseline, 6-months (post intervention follow-up) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 127 |
| 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. | 122 |
| Total | 249 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 18-month post intervention | Lost to Follow-up | 3 | 1 |
| 6-month post intervention | Lost to Follow-up | 5 | 4 |
| 6-month post intervention | Withdrawal by Subject | 4 | 0 |
| 9-week | Excluded from analysis due to missing covariates | 2 | 1 |
| 9-week | Lost to Follow-up | 10 | 7 |
| 9-week | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Patient Education (PE) | Total | iSIPsmarter |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 8 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 116 Participants | 241 Participants | 125 Participants |
| Age, Continuous | 41.2 years STANDARD_DEVIATION 13.2 | 41.6 years STANDARD_DEVIATION 12.6 | 42.0 years STANDARD_DEVIATION 13.2 |
| Annual Household Income <= $14,999 | 8 Participants | 17 Participants | 9 Participants |
| Annual Household Income $15,000-$34,999 | 22 Participants | 49 Participants | 27 Participants |
| Annual Household Income $35,000-$54,999 | 36 Participants | 62 Participants | 26 Participants |
| Annual Household Income >= $55,000 | 56 Participants | 119 Participants | 63 Participants |
| Annual Household Income Unknown or unreported | 0 Participants | 2 Participants | 2 Participants |
| BMI, categorical Normal | 28 Participants | 58 Participants | 30 Participants |
| BMI, categorical Obesity Class 1 | 27 Participants | 55 Participants | 28 Participants |
| BMI, categorical Obesity Class 2 | 19 Participants | 38 Participants | 19 Participants |
| BMI, categorical Obesity Class 3 | 20 Participants | 48 Participants | 28 Participants |
| BMI, categorical Overweight | 22 Participants | 39 Participants | 17 Participants |
| BMI, categorical Underweight | 1 Participants | 1 Participants | 0 Participants |
| BMI, continuous | 32.5 kg/m^2 STANDARD_DEVIATION 8 | 33.2 kg/m^2 STANDARD_DEVIATION 8.7 | 33.8 kg/m^2 STANDARD_DEVIATION 9 |
| Education Level, categorical <= High school graduate | 9 Participants | 23 Participants | 14 Participants |
| Education Level, categorical Some college or greater | 113 Participants | 226 Participants | 113 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 118 Participants | 239 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Perceived Health Literacy, continuous | 11.5 units on a scale STANDARD_DEVIATION 0.99 | 11.5 units on a scale STANDARD_DEVIATION 0.99 | 11.6 units on a scale STANDARD_DEVIATION 1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 13 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 8 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 108 Participants | 221 Participants | 113 Participants |
| Region of Enrollment United States | 122 participants | 249 participants | 127 participants |
| Rurality Status, categorical RUCC 1-2 | 20 Participants | 36 Participants | 16 Participants |
| Rurality Status, categorical RUCC 3 | 54 Participants | 111 Participants | 57 Participants |
| Rurality Status, categorical RUCC 4-9 | 48 Participants | 102 Participants | 54 Participants |
| Sex/Gender, Customized Female | 104 Participants | 207 Participants | 103 Participants |
| Sex/Gender, Customized Male | 17 Participants | 41 Participants | 24 Participants |
| Sex/Gender, Customized Other | 1 Participants | 1 Participants | 0 Participants |
| Sugar-sweetened beverage fluid milliliters/day | 1144.5 fluid milliliters/day STANDARD_DEVIATION 603.3 | 1230.2 fluid milliliters/day STANDARD_DEVIATION 692 | 1313.1 fluid milliliters/day STANDARD_DEVIATION 760 |
| Sugary-sweetened beverage kilocalories/day | 446.2 kilocalories/day STANDARD_DEVIATION 249.7 | 481.0 kilocalories/day STANDARD_DEVIATION 287.7 | 514.4 kilocalories/day STANDARD_DEVIATION 317.5 |
| Weight, continuous | 90.6 kilograms STANDARD_DEVIATION 23.6 | 92.4 kilograms STANDARD_DEVIATION 25.4 | 94.2 kilograms STANDARD_DEVIATION 26.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 127 | 0 / 122 |
| other Total, other adverse events | 0 / 127 | 0 / 122 |
| serious Total, serious adverse events | 0 / 127 | 0 / 122 |
Outcome results
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.
Time frame: Baseline, 9-weeks (immediate-post follow-up)
Population: 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).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| iSIPsmarter | Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 9-weeks | -897.0 fluid milliters/day |
| Patient Education (PE) | Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 9-weeks | -291.0 fluid milliters/day |
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).
Time frame: Baseline, 6-months (post intervention follow-up)
Population: Participants who completed dietary recalls at all time points (Baseline, 9-weeks, 6-months, and 18 months).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| iSIPsmarter | Change From Baseline Dietary Quality as Measured by the Healthy Eating Index (HEI) Score at 6-months | 3.33 score on a scale |
| Patient Education (PE) | Change From Baseline Dietary Quality as Measured by the Healthy Eating Index (HEI) Score at 6-months | 1.65 score on a scale |
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).
Time frame: Baseline, 9-weeks (immediate-post follow-up)
Population: Participants who completed dietary recalls at all time points (Baseline, 9-weeks, 6-months, and 18 months).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| iSIPsmarter | Change From Baseline Dietary Quality as Measured by the Healthy Eating Index (HEI) Score at 9-weeks | 1.70 score on scale |
| Patient Education (PE) | Change From Baseline Dietary Quality as Measured by the Healthy Eating Index (HEI) Score at 9-weeks | 2.82 score on scale |
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).
Time frame: Baseline, 18-months (post intervention follow-up)
Population: Participants who completed dietary recalls at all time points (Baseline, 9-weeks, 6-months, and 18 months).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| iSIPsmarter | Change From Baseline Dietary Quality as Measured the Healthy Eating Index (HEI) Score at 18 Months | 4.18 score on a scale |
| Patient Education (PE) | Change From Baseline Dietary Quality as Measured the Healthy Eating Index (HEI) Score at 18 Months | 3.21 score on a scale |
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.
Time frame: Baseline, 18-months (post intervention follow-up)
Population: 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).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| iSIPsmarter | Change From Baseline Overall Quality of Life at 18-months | -0.71 score on a scale |
| Patient Education (PE) | Change From Baseline Overall Quality of Life at 18-months | -1.92 score on a scale |
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.
Time frame: Baseline, 6-months (post intervention follow-up)
Population: 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).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| iSIPsmarter | Change From Baseline Overall Quality of Life at 6-months | -5.08 score on a scale |
| Patient Education (PE) | Change From Baseline Overall Quality of Life at 6-months | -5.31 score on a scale |
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.
Time frame: Baseline, 9-weeks (immediate post-folllow-up)
Population: 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).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| iSIPsmarter | Change From Baseline Overall Quality of Life at 9-weeks | -0.61 score on a scale |
| Patient Education (PE) | Change From Baseline Overall Quality of Life at 9-weeks | -1.28 score on a scale |
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.
Time frame: Baseline, 18-months (post itnervention follow-up)
Population: 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).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| iSIPsmarter | Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 18-months Post Intervention | -893.1 fluid milliters/day |
| Patient Education (PE) | Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 18-months Post Intervention | -618.7 fluid milliters/day |
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.
Time frame: Baseline, 6-months (post-intervention follow-up)
Population: 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).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| iSIPsmarter | Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 6-months Post Intervention | -858.2 fluid milliters/day |
| Patient Education (PE) | Change From Baseline Sugar-sweetened Beverage Fluid Milliters/Day at 6-months Post Intervention | -279.5 fluid milliters/day |
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).
Time frame: Baseline, 18-months (post-intervention follow-up)
Population: 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).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| iSIPsmarter | Percent Weight Change From Baseline Weight at 18-months | -2.97 percent weight change |
| Patient Education (PE) | Percent Weight Change From Baseline Weight at 18-months | -0.000003 percent weight change |
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).
Time frame: Baseline, 6-months (post-intervention follow-up)
Population: 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).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| iSIPsmarter | Percent Weight Change From Baseline Weight at 6-months | -1.95 percent weight change |
| Patient Education (PE) | Percent Weight Change From Baseline Weight at 6-months | -0.55 percent weight change |
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).
Time frame: Baseline, 9-weeks (immediate-post follow-up)
Population: 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).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| iSIPsmarter | Percent Weight Change From Baseline Weight at 9-weeks | -1.13 percent weight change |
| Patient Education (PE) | Percent Weight Change From Baseline Weight at 9-weeks | -0.05 percent weight change |