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Expanding the reach of the Nutritious Eating with Soul (NEW Soul) program: A Type 2 hybrid effectiveness-implementation trial

Award Number: R01HL163714
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/15/2022
PERIOD OF PERFORMANCE END DATE: 03/31/2027

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Expanding the reach of the Nutritious Eating with Soul (NEW Soul) program: A Type 2 hybrid effectiveness-implementation trial - Project Summary/Abstract African Americans (AAs) are disproportionately affected by cardiovascular disease (CVD) and obesity. AA vegetarians/vegans have significantly lower risks of hypertension and diabetes as compared to AA omnivores. Vegan soul food restaurants have emerged as a potential community partner for introducing patrons to healthy versions of familiar soul food cuisine. To explore the potential impact of this intervention on AAs with overweight or obesity who were not already following vegan diets, we conducted the Nutritious Eating with Soul intervention (NEW Soul; R01HL135220), delivered in a university setting in Columbia, SC (n=159 AAs; vegan vs. low-fat omnivorous diet, both focused on soul food). We completed 3-month assessments with high retention rates (88%) and significant weight loss (vegan -2.2±2.8 kgs; omnivorous -1.2±2.7 kgs; p=0.03). We propose to examine the effectiveness and implementation of a remotely-delivered, 3-month NEW Soul program. We will work with two vegan soul food restaurants (see letters of support). We have the following aims: Aim 1: Evaluate the effectiveness of the 3-month NEW Soul restaurant-delivered program on two important factors in the development of CVD (body weight and diet quality) among AAs with overweight or obesity. Participants (n=228) will be randomized to one of two conditions: 1. Remotely delivered live weekly classes with restaurant vouchers (intervention) or 2. restaurant voucher-only (active control). Aim 2: Conduct a cost-effectiveness analysis of delivering the online intervention plus voucher vs. voucher- only with the outcome of cost/change in weight, HEI and quality adjusted life year (QALY). This includes estimating costs of the intervention itself (e.g., training, delivery, infrastructure). Aim 3a: Examine the implementation of the NEW Soul study. Guided by the implementation outcome framework by Proctor, et. al., and the implementation strategies described by Waltz, et. al., we will examine the feasibility and utility of the NEW Soul implementation strategies (e.g., provide iterative assistance, provide ongoing training and consultation, centralize technical assistance) in restaurant settings. We will employ qualitative (semi-structured interviews with intervention staff and focus groups with participants), and quantitative (surveys with participants) research methods, which will be guided by CFIR domains (intervention characteristics, inner setting, outer setting, characteristics of individuals, and process). Aim 3b: Building on the findings from Aims 1-3a, we will conduct key informant interviews with intervention and restaurant staff to identify areas to prepare the intervention for widespread adoption by vegan soul food restaurants across the southeast. We will focus on the design quality and packaging, part of the CFIR “intervention characteristics” domain.


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: 2025 ( Subtotal = $719,517 )
2025	2025	UNIVERSITY OF SOUTH CAROLINA	1600 HAMPTON ST	COLUMBIA	SC	29208	RICHLAND	USA	Cardiovascular Diseases Research	000	4	3/27/2025	NON-COMPETING CONTINUATION	$647,567
2025	2025	UNIVERSITY OF SOUTH CAROLINA	1600 HAMPTON ST	COLUMBIA	SC	29208	RICHLAND	USA	Cardiovascular Diseases Research	001	4	9/17/2025	NON-COMPETING CONTINUATION	$71,950
														Subtotal = $719,517

Issue Date FY: 2024 ( Subtotal = $706,953 )
2024	2024	UNIVERSITY OF SOUTH CAROLINA	1600 HAMPTON ST	COLUMBIA	SC	29208	RICHLAND	USA	Cardiovascular Diseases Research	000	3	3/1/2024	NON-COMPETING CONTINUATION	$649,243
2024	2024	UNIVERSITY OF SOUTH CAROLINA	1600 HAMPTON ST	COLUMBIA	SC	29208	RICHLAND	USA	Cardiovascular Diseases Research	001	3	6/22/2024	NON-COMPETING CONTINUATION	$57,710
														Subtotal = $706,953

Issue Date FY: 2023 ( Subtotal = $722,497 )
2023	2023	UNIVERSITY OF SOUTH CAROLINA	1600 HAMPTON ST # 414	COLUMBIA	SC	29208	RICHLAND	USA	Cardiovascular Diseases Research	000	2	3/22/2023	NON-COMPETING CONTINUATION	$722,497
														Subtotal = $722,497

Issue Date FY: 2022 ( Subtotal = $727,353 )
2022	2022	UNIVERSITY OF SOUTH CAROLINA	1600 HAMPTON ST # 414	COLUMBIA	SC	29208	RICHLAND	USA	Cardiovascular Diseases Research	000	1	4/11/2022	NEW	$727,353
														Subtotal = $727,353

Grand Total All Awards = $2,876,320

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Expanding the reach of the Nutritious Eating with Soul (NEW Soul) program: A Type 2 hybrid effectiveness-implementation trial

Award Number: R01HL163714

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/15/2022

PERIOD OF PERFORMANCE END DATE: 03/31/2027

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