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Diet Interventions: Remitted and Evaluated as Complementary Treatments for Pain (DIRECTPain)

Award Number: R01NR020523
ORGANIZATION: NATIONAL INSTITUTE OF NURSING RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/21/2022
PERIOD OF PERFORMANCE END DATE: 06/30/2027

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Diet Interventions: Remitted and Evaluated as Complementary Treatments for Pain (DIRECTPain) - Knee osteoarthritis (OA) is the most prevalent form of arthritis and a significant cause of lost productivity in the U.S. As the population ages and obesity rates increase, the rates of knee OA climb as well, impacting quality of life (QOL) for millions. Current national efforts to reduce analgesic utilization highlight the critical need for safe and effective alternatives for pain relief. Low-carbohydrate diets (LCDs) reduce inflammation and pain independent of weight loss, indicating that diet interventions offer a non-pharmacological complementary treatment. However, differences between individuals exist in metabolism that are rarely addressed in diet interventions. Thus, it is important to assess the potential of different diets in a broad population of chronic pain sufferers to determine the potential of diets to reduce knee OA pain. Here, we will recruit adults (n=200) with knee OA to complete our two-phase protocol. Phase 1 will involve a 1-week diet run-up that will allow for quantification of pain measures, psychosocial variables (socioeconomic status, nutritional knowledge, proximity to grocery stores, food insecurity), and diet quality to provide a baseline for comparison. Phase 2 will be a 6-week diet intervention (LCD or USDA diet) in which both groups will be provided with all meals at the direction of study personnel and input from participants. Evoked pain tasks, measures of pain severity, catastrophizing, and interference will be assessed every 3 weeks in addition to QOL measures, mood, and depression. Physiological variables will be assessed through blood draws (inflammatory profile) and dual-energy X-ray absorptiometry scans (DXA; body composition, visceral fat) at the end of Phases 1 and 2. This will be the first study to examine the efficacy of these diets to reduce knee OA pain and interactions with biopsychosocial variables. Changes in all pain measures following Phase 2 will be assessed with respect to published measures of clinically-meaningful differences in pain, as well as for statistical significance. The central hypothesis is that the LCD will improve pain and QOL in participants with knee OA more than the USDA diet, but that both will be beneficial.


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 = $445,763 )
2026	2026	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Nursing Research	000	5	7/23/2026	NON-COMPETING CONTINUATION	$445,763
														Subtotal = $445,763

Issue Date FY: 2025 ( Subtotal = $620,775 )
2025	2025	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Nursing Research	000	4	7/1/2025	NON-COMPETING CONTINUATION	$620,775
														Subtotal = $620,775

Issue Date FY: 2024 ( Subtotal = $608,731 )
2024	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Nursing Research	000	3	5/28/2024	NON-COMPETING CONTINUATION	$608,731
														Subtotal = $608,731

Issue Date FY: 2023 ( Subtotal = $602,791 )
2023	2023	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Nursing Research	000	2	6/23/2023	NON-COMPETING CONTINUATION	$602,791
														Subtotal = $602,791

Issue Date FY: 2022 ( Subtotal = $525,800 )
2022	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Nursing Research	000	1	9/21/2022	NEW	$525,800
														Subtotal = $525,800

Grand Total All Awards = $2,803,860

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Diet Interventions: Remitted and Evaluated as Complementary Treatments for Pain (DIRECTPain)

Award Number: R01NR020523

ORGANIZATION: NATIONAL INSTITUTE OF NURSING RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/21/2022

PERIOD OF PERFORMANCE END DATE: 06/30/2027

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