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Optimization and Evaluation of a Tailored Behavioral eHealth/mHealth Weight Loss Intervention for Cardiac Rehabilitation Patients Using the Multiphase Optimization Strategy

Award Number: K23HL136845
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

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PROJECT SUMMARY/ABSTRACT Cardiovascular disease (CVD) is the leading cause of death in the United States. Cardiac rehabilitation (CR) is an evidence-based, cost-effective, and widely-available multidisciplinary program that combines supervised exercise with psychoeducation on health behavior change aimed at improving overall health and reducing cardiovascular risk in individuals with established CVD. Despite CR's ample attention to increasing physical activity (PA) and improving diet it produces almost no weight loss (WL). WL would significantly improve the CR patients' health, the majority of who present to CR with obesity. Gold standard in-person behavioral weight loss interventions (BWLs) produce clinically significant WL that improves health and disease risk/severity, but these programs are so burdensome and costly that they are impossible to conduct within existing CR programs. The primary mentor's fully automated 3-month online program, Rx Weight Loss (RxWL), produced clinically significant mean±SD WL of 5.8±4.4 % of initial body weight in physician-referred patients (N=154), 5.8 ±5.2 % in worksites (N=75), and 4.2±5.3 % in community settings (N=230); this was maintained at 6-months. Dr. Goldstein, the candidate, aims to conduct formative work to tailor RxWL for use in CR. She will then use the Multiphase Optimization Strategy (MOST) to rapidly screen 4 innovative eHealth/mHealth intervention components with the potential to improve WL in this special population when combined with the core RxWL program. Following pilot testing with n=20, a fully-powered 24 full factorial experiment with 160 patients (each randomized to receive 0-4 of the components) will be used to test the 4 novel intervention components: (a) a tailored interactive intervention to promote structured PA using a Fitbit; (b) a bite counting device to promote caloric restriction; (c) a Web-based virtual reality (VR) intervention for BWL skills implementation; and (d) virtual meetings to increase WL self-efficacy. By the 6-month follow-up, this design will allow the candidate to determine which components maximize WL and whether there are favorable component combinations. Dr. Goldstein will test which components are (or are not) effective and why or how they exert their effects, which is critical for understanding their mechanism of action (or inaction). Each component will be required to meet a 2% WL optimization criterion for inclusion in the final treatment package. This research will result in a fully- automated BWL treatment package optimized for CR, which will be submitted for testing in a randomized controlled trial (RCT) in an R01 developed during the K23 grant period. Given the candidate's success while earning her PhD from Kent State University and completing an NHLBI-funded Cardiovascular Behavioral Medicine T32 at The Miriam Hospital and Brown University, the candidate will undoubtedly leverage the resources in her exemplary research environment to develop into a successful, independent scientist. Through a robust training plan and innovative research project, Dr. Goldstein will become one of the only independent scientists to use eHealth/mHealth technology to facilitate WL in CVD, specifically CR, patients.


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: 2023 ( Subtotal = $0 )
2023	2022	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	001	5	3/30/2023	NON-COMPETING CONTINUATION	$0
2023	2022	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	000	5	12/3/2022	SUPPLEMENT FOR EXPANSION	$0
2023	2022	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	002	5	3/31/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $235,107 )
2022	2022	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	002	5	3/29/2022	SUPPLEMENT FOR EXPANSION	$54,000
2022	2022	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	001	5	3/29/2022	NON-COMPETING CONTINUATION	$0
2022	2022	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	000	5	1/14/2022	NON-COMPETING CONTINUATION	$181,107
														Subtotal = $235,107

Issue Date FY: 2021 ( Subtotal = $178,063 )
2021	2021	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	000	4	1/26/2021	NON-COMPETING CONTINUATION	$178,063
														Subtotal = $178,063

Issue Date FY: 2020 ( Subtotal = $175,106 )
2020	2020	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	000	3	2/12/2020	NON-COMPETING CONTINUATION	$175,106
														Subtotal = $175,106

Issue Date FY: 2019 ( Subtotal = $172,236 )
2019	2019	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	000	2	1/31/2019	NON-COMPETING CONTINUATION	$172,236
														Subtotal = $172,236

Issue Date FY: 2018 ( Subtotal = $169,450 )
2018	2018	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Cardiovascular Diseases Research	000	1	2/22/2018	NEW	$169,450
														Subtotal = $169,450

Grand Total All Awards = $929,962

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Optimization and Evaluation of a Tailored Behavioral eHealth/mHealth Weight Loss Intervention for Cardiac Rehabilitation Patients Using the Multiphase Optimization Strategy

Award Number: K23HL136845

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

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