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A behavioral intervention to optimize self-management of celiac disease in adolescents

Award Number: K23DK129826
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 09/27/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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A behavioral intervention to optimize self-management of celiac disease in adolescents - PROJECT SUMMARY/ABSTRACT Celiac disease (CD) is a chronic autoimmune condition whose only currently available treatment is a strict, burdensome gluten-free diet (GFD). The current proposal uses a theory-driven empirical approach for optimizing the GFD for teens and their parents by targeting knowledge, behavior, and coping skills through educational and cognitive behavioral techniques. Integration with telehealth and SMS (short-message service; “text”) technology for delivering the intervention has the potential reduce barriers to specialized treatment at both early and later stages of implementation. This mentored K23 award aligns with NIDDK's mission to “conduct and support medical research and research training and to disseminate science-based information” to conditions such as digestive diseases to improve people's health and quality of life. The proposed training and research plan will provide the necessary experience and training opportunities for the candidate to achieve a long-term career as an independent clinical researcher in optimizing CD treatment for youth and their families. The proposed K23 project and training plan is designed achieve this goal through advanced training in (1) Developing and evaluating patient-centered family interventions in real-world settings; (2) Utilization and statistical analysis of technology for behavioral interventions; (3) Measuring self-management in youth with chronic GI illness; and (4) Enhancing intervention-based grant writing skills and research dissemination. The proposed research and training plan is fully supported by the institution (Children's National Hospital) and will be guided by a multidisciplinary team of two co-mentors and four scientific advisors with expertise in family interventions for pediatric chronic illness (Dr. Streisand, Primary Mentor, Dr. Hinds, Co-Mentor, and Dr. Opipari-Arrigan, Advisor), CD treatment and evaluation of GFD management (Drs. Kerzner and Liu), and advanced research methods (Dr. Bost). The proposed research will refine and test a behavioral intervention for teens with CD and their parents using an iterative stakeholder-centered design. It will consist of refinement of a behavioral intervention for use with teens (ages 12-16) and their parents through a series of focus groups (n=5 dyads), followed by proof of concept testing (n=5 dyads) and a small pilot RCT (n=60 dyads). Proof of concept testing will examine intervention feasibility, acceptability, impact, and lead to further refinements based on feedback. The RCT will examine preliminary efficacy of the intervention and its impact on QOL and GFD management by targeting self-efficacy, illness identity, and food-related activities. The innovative and significant data resulting from this K23 will directly position the candidate to secure future funding as an independent investigator. This research would provide preliminary data to support a large-scale RCT of the intervention, with continued leveraging of technology such as telehealth and text messaging to facilitate access and reach. This work has the potential to make a lasting impact on the standards of care and available treatments to optimize CD management in youth and their families.


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: 2024 ( Subtotal = $142,899 )
2024	2024	CHILDREN'S RESEARCH INSTITUTE	111 MICHIGAN AVE NW	WASHINGTON	DC	20010	DISTRICT OF COLUMBIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	8/27/2024	NON-COMPETING CONTINUATION	$142,899
														Subtotal = $142,899

Issue Date FY: 2023 ( Subtotal = $141,370 )
2023	2023	CHILDREN'S RESEARCH INSTITUTE	111 MICHIGAN AVE NW	WASHINGTON	DC	20010	DISTRICT OF COLUMBIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	9/1/2023	NON-COMPETING CONTINUATION	$141,370
														Subtotal = $141,370

Issue Date FY: 2022 ( Subtotal = $145,419 )
2022	2022	CHILDREN'S RESEARCH INSTITUTE	111 MICHIGAN AVE NW	WASHINGTON	DC	20010	DISTRICT OF COLUMBIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	9/2/2022	NON-COMPETING CONTINUATION	$145,419
														Subtotal = $145,419

Issue Date FY: 2021 ( Subtotal = $146,504 )
2021	2021	CHILDREN'S RESEARCH INSTITUTE	111 MICHIGAN AVE NW	WASHINGTON	DC	20010	DISTRICT OF COLUMBIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/13/2021	NEW	$146,504
														Subtotal = $146,504

Grand Total All Awards = $576,192

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A behavioral intervention to optimize self-management of celiac disease in adolescents

Award Number: K23DK129826

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 09/27/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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