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Pilot Trial of a Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation

Award Number: R01DK147319
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2026
PERIOD OF PERFORMANCE END DATE: 07/31/2029

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Pilot Trial of a Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation - PROJECT SUMMARY/ABSTRACT Next-generation GLP-1 receptor agonists and anti-obesity medications (AOMs) have revolutionized obesity treatment by enabling substantial weight loss. However, many patients discontinue these medications within the first year, and weight regain is common following discontinuation. Despite this growing challenge, no validated, scalable interventions exist to support weight loss maintenance (WLM) after AOM discontinuation. This pilot study will evaluate a multi-component behavioral intervention designed to replace the regulatory functions lost after stopping AOMs. The intervention targets the primary vulnerabilities driving post-medication weight regain: appetite resurgence, metabolic inflexibility, and suboptimal mindstate. Grounded in a Food, Physical Activity, and Mind as Medicine conceptual model, the program uses structured eating, physical activity, and mind-based practices to support sustainable WLM. All participants will complete a standardized 10-week WLM program with continued behavioral support through six months, including weekly virtual group sessions and access to a peer support community. Participants (n=64) will be randomized using a 2×2×2 factorial design to receive or not receive three candidate support components: (1) medically tailored meals, (2) YMCA access, and (3) the SKY Meditation program. Participants will be followed for six months, with assessments of weight, dietary intake, physical activity, and engagement in mind-based practices using a combination of digital tools and in-person measurements. Specific aims are: (1) to assess feasibility, acceptability, and participant perceptions of the intervention and its components, and (2) to estimate preliminary effects on key behavioral outcomes. As a small R01 pilot trial, this study is embedded in the Preparation Phase of the Multiphase Optimization Strategy (MOST) framework and is designed to inform a future optimization trial. This project addresses an urgent gap in obesity care and aligns with NIDDK’s mission to reduce the burden of chronic disease through prevention and sustainable treatment. It aims to deliver a scalable, real-world intervention to support long-term weight maintenance after AOM discontinuation.


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 = $298,000 )
2026	2026	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	6/12/2026	NEW	$298,000
														Subtotal = $298,000

Grand Total All Awards = $298,000

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Pilot Trial of a Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation

Award Number: R01DK147319

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2026

PERIOD OF PERFORMANCE END DATE: 07/31/2029

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