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Teaching Novel Values-Based Skills to Improve Long-Term Weight Loss: A Randomized Trial Examining the Efficacy of a Weight Loss Maintenance Intervention Based on Acceptance and Commitment Therapy

Award Number: R01DK120731
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: 09/23/2019
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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Teaching Novel Values-Based Skills to Improve Long-Term Weight Loss: A Randomized Trial Examining the Efficacy of a Weight Loss Maintenance Intervention Based on Acceptance and Commitment Therapy - PROJECT SUMMARY/ABSTRACT This proposal is for an investigator-initiated clinical trial R01. Obesity is a major public health problem, and although short-term weight loss is achievable, individuals often regain the majority of weight that was lost. Current approaches have adjusted behavioral prescriptions and lengthened treatment contact in an effort to address this problem, with modest effect. The investigators of this proposal have developed and piloted a brief intervention based on Acceptance and Commitment Therapy (ACT) that focuses on teaching novel content and skills that promote values clarification and commitment; providing the needed motivation to continue with weight control efforts. In a pilot study, participants (N=102) who recently lost ≥5% in a behavioral weight loss program were randomly assigned to receive (a) 5-hour ACT workshop, a 5-hour workshop based on Self- Regulation (SR), or a no workshop control condition (Control), with all groups receiving 3 months of follow-up email contact. The ACT group had greater weight loss at 24 months (7.2%) relative to the SR (4.2%; Cohen’s d=.39) and Control (-1.1%; d=.73). These results represent a potential paradigm shift for improving weight loss maintenance towards teaching completely novel skills delivered in brief format, warranting study in a larger trial. Therefore, the proposed R01 project is a randomized controlled clinical trial to compare the efficacy of an ACT intervention and a SR intervention on weight loss maintenance over a 30-month period. All participants will first complete a well-validated online weight loss intervention (months 1-3 of the study). Participants who lose ≥4 kilograms of initial weight will then be randomly assigned to receive ACT or SR, with both conditions consisting of three face-to-face, group-based intervention meetings (10 hours total) and weekly email contact for 6 months. The ACT intervention will target a novel theoretically derived intervention target, values- consistent behavior, which will help align weight loss goals with personal values and foster internal motivation to continue with weight control efforts. Assessments will be at baseline, post-weight loss/pre-randomization, and then 6, 12, 18, 24, and 30-month follow-up (months from randomization). We hypothesize that the ACT group will show significantly better weight loss maintenance (i.e. lower mean weight gain) at 30 months as compared to SR. The primary site for this award is the Weight Control and Diabetes Research Center (WCDRC). The WCDRC is part of the Centers for Behavioral and Preventive Medicine at The Miriam Hospital in Providence, Rhode Island, and the Department of Psychiatry and Human Behavior at the Alpert Medical School of Brown University. This study is significant because it addresses weight loss maintenance – a critical barrier to treating obesity – and results of the study could be used to improve long-term weight loss outcomes and associated health benefits for treatment seeing overweight and obese adults.


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 = -$713 )
2026	2023	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	3/17/2026	NON-COMPETING CONTINUATION	-$713
														Subtotal = -$713

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2023	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	6/10/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $415,918 )
2023	2023	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	5/26/2023	NON-COMPETING CONTINUATION	$415,918
														Subtotal = $415,918

Issue Date FY: 2022 ( Subtotal = $411,505 )
2022	2022	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	5/25/2022	NON-COMPETING CONTINUATION	$411,505
														Subtotal = $411,505

Issue Date FY: 2021 ( Subtotal = $451,559 )
2021	2021	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	6/4/2021	NON-COMPETING CONTINUATION	$451,559
														Subtotal = $451,559

Issue Date FY: 2020 ( Subtotal = $507,997 )
2020	2020	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	5/20/2020	NON-COMPETING CONTINUATION	$507,997
2020	2019	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	12/4/2019	NEW	$0
														Subtotal = $507,997

Issue Date FY: 2019 ( Subtotal = $518,379 )
2019	2019	THE MIRIAM HOSPITAL	164 SUMMIT AVE	PROVIDENCE	RI	02906	PROVIDENCE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/21/2019	NEW	$518,379
														Subtotal = $518,379

Grand Total All Awards = $2,304,645

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Teaching Novel Values-Based Skills to Improve Long-Term Weight Loss: A Randomized Trial Examining the Efficacy of a Weight Loss Maintenance Intervention Based on Acceptance and Commitment Therapy

Award Number: R01DK120731

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: 09/23/2019

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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