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Optimizing iSIPsmarter: A Factorial Trial to Enhance Engagement and Effectiveness on Sugary Beverages and Weight among rural Appalachian adults

Award Number: R01MD015033
ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/22/2020
PERIOD OF PERFORMANCE END DATE: 04/30/2031

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Optimizing iSIPsmarter: A Factorial Trial to Enhance Engagement and Effectiveness on Sugary Beverages and Weight among rural Appalachian adults - Project Summary: Reducing consumption of ultra-processed foods/beverages, particularly sugar-sweetened beverages (SSBs) and foods high in added sugars (AS), is a national public health priority. Overconsumption of AS, especially from SSBs, is a well-established risk factor for chronic disease and disproportionately affects medically underserved rural populations. While digital health interventions (DHIs) can modestly improve nutrition and weight outcomes, most fail to sustain reductions in SSB and AS intake, struggle with long-term engagement, rely on staff- or clinician-supported components, and lack evidence for scalable implementation in resource-limited rural primary care settings. This project addresses these gaps by optimizing iSIPsmarter, a fully digital, self-guided intervention focused on reducing SSB intake. Previously tested in a randomized controlled trial in rural Appalachia, iSIPsmarter includes six interactive Core modules, daily SMS-based SSB self-monitoring, Wi-Fi scale-based weight tracking, and personalized action planning. Although effective at sustaining SSB and weight improvements at 18 months, other dietary data and robust process data highlight key opportunities to amplify iSIPsmarter’s effectiveness. Also, its reliance on human stepped-care was resource-intensive; and may not be necessary if new engagement strategies are effective. This study will use a factorial optimization trial, guided by the Multiphase Optimization Strategy (MOST), and will engage rural primary care clinics as decision makers through a Type 1 Hybrid effectiveness-implementation approach. Recruitment will focus on rural Appalachia and participants (n=304) will be randomized to four experimental components: (1) core content (base vs. expanded content addressing high-AS foods), (2) enhanced action plan barrier mitigation (On/Off), (3) sustained self-monitoring maintenance prompts (On/Off), and (4) human- supported stepped care (On/Off). Outcomes will be assessed at baseline, 12-weeks, and at 6- and 18-month follow-ups. Leveraging the 2⁴ factorial design, the study will estimate the individual and combined effects of each experimental component on SSB consumption (primary) as well as % kilocalories from AS and % body weight change (secondary). Decision Analysis for Intervention Value Efficiency (DAIVE) will be used to compare the relative performance of the alternative versions of iSIPsmarter in terms of the primary and secondary outcomes. A participatory decision-making process will guide the selection of the version that offers the best value while aligning with rural clinics’ priorities and resource constraints. Factorial mediation analysis will explore how components influence outcomes via behavioral mechanisms (i.e., self-regulation, problem solving, and self-monitoring beliefs, supportive accountability) and engagement-related mechanisms (i.e., behavioral, affective and cognitive engagement). By optimizing effectiveness in alignment with the needs of rural primary care, this study will generate evidence to support the future implementation and sustainable delivery of iSIPsmarter and advance efforts to reduce nutrition-related chronic disease in rural populations.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $809,902 )
2026	2026	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Minority Health and Health Disparities Research	002	6	8/26/2026	COMPETING CONTINUATION	-$3,212,891
2026	2026	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Minority Health and Health Disparities Research	001	6	8/25/2026	COMPETING CONTINUATION	$4,030,903
2026	2024	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Minority Health and Health Disparities Research	000	5	4/30/2026	NON-COMPETING CONTINUATION	-$8,111
														Subtotal = $809,902

Issue Date FY: 2024 ( Subtotal = $664,982 )
2024	2024	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Minority Health and Health Disparities Research	001	5	5/24/2024	NON-COMPETING CONTINUATION	$47,987
2024	2024	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Minority Health and Health Disparities Research	000	5	12/3/2023	NON-COMPETING CONTINUATION	$616,995
														Subtotal = $664,982

Issue Date FY: 2023 ( Subtotal = $679,552 )
2023	2023	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Minority Health and Health Disparities Research	001	4	12/19/2022	NON-COMPETING CONTINUATION	$611,599
2023	2023	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Minority Health and Health Disparities Research	002	4	2/13/2023	NON-COMPETING CONTINUATION	$67,953
2023	2022	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Minority Health and Health Disparities Research	000	3	12/19/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $679,552

Issue Date FY: 2022 ( Subtotal = $685,337 )
2022	2022	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Minority Health and Health Disparities Research	000	3	12/20/2021	NON-COMPETING CONTINUATION	$616,804
2022	2022	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Minority Health and Health Disparities Research	001	3	4/29/2022	NON-COMPETING CONTINUATION	$68,533
														Subtotal = $685,337

Issue Date FY: 2021 ( Subtotal = $690,154 )
2021	2021	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Minority Health and Health Disparities Research	002	2	3/15/2021	NON-COMPETING CONTINUATION	$69,015
2021	2021	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Minority Health and Health Disparities Research	001	2	12/1/2020	NON-COMPETING CONTINUATION	$621,139
2021	2020	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Minority Health and Health Disparities Research	000	1	10/29/2020	NEW	$0
														Subtotal = $690,154

Issue Date FY: 2020 ( Subtotal = $695,270 )
2020	2020	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Minority Health and Health Disparities Research	000	1	4/22/2020	NEW	$695,270
														Subtotal = $695,270

Grand Total All Awards = $4,225,197

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Optimizing iSIPsmarter: A Factorial Trial to Enhance Engagement and Effectiveness on Sugary Beverages and Weight among rural Appalachian adults

Award Number: R01MD015033

ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/22/2020

PERIOD OF PERFORMANCE END DATE: 04/30/2031

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