TY - JOUR
T1 - The ENGAGE-2 study
T2 - Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes in a randomized controlled trial (Phase 2)
AU - Lv, Nan
AU - Ajilore, Olusola A.
AU - Ronneberg, Corina R.
AU - Venditti, Elizabeth M.
AU - Snowden, Mark B.
AU - Lavori, Philip W.
AU - Xiao, Lan
AU - Goldstein-Piekarski, Andrea N.
AU - Wielgosz, Joseph
AU - Wittels, Nancy E.
AU - Barve, Amruta
AU - Patel, Aashutos S.
AU - Eckley, Tessa L.
AU - Stetz, Patrick
AU - Gerber, Ben S.
AU - Smyth, Joshua M.
AU - Simmons, Janine M.
AU - Rosas, Lisa G.
AU - Williams, Leanne M.
AU - Ma, Jun
N1 - Funding Information:
The project described is supported by the National Institutes of Health (NIH) Science of Behavior Change Common Fund Program through an award administered by the National Heart, Lung, and Blood Institute grant number UH2HL132368 and UH3HL132368. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung and Blood Institute or the National Institutes of Health. No sponsor or funding source has a role in the design or conduct of the study; collection, management, analysis or interpretation of the data; or preparation, review or approval of the manuscript. The authors extend special thanks to the ENGAGE-2 participants and their families who make this study possible. The authors also thank the study Data and Safety Monitoring Board members (Manisha Desai, PhD [Chair], Mickey Trockel, MD, Manpreet K. Singh, MD, MS, and Sandra Tsai, MD), and the study team members who have made substantial contributions to the conduct of the ENGAGE-2 study or to data acquisition and analyses from ENGAGE Phase 1 study that informed this protocol (Justine L Kessler, MPH, Sushanth Dosala, MBBS, Rohit Shrestha, MBBS, Emil J Thomas, MD, Vikas Kumar, BS, Sumeet S Birla, MS, Sarah Chang, BSc, and Carlos Correa, BCompSci).
Funding Information:
The project described is supported by the National Institutes of Health (NIH) Science of Behavior Change Common Fund Program through an award administered by the National Heart, Lung, and Blood Institute grant number UH2HL132368 and UH3HL132368 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung and Blood Institute or the National Institutes of Health . No sponsor or funding source has a role in the design or conduct of the study; collection, management, analysis or interpretation of the data; or preparation, review or approval of the manuscript.
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/8
Y1 - 2020/8
N2 - Despite evidence for effective integrated behavior therapy for treating comorbid obesity and depression, treatment response is highly variable and the underlying neurobiological mechanisms remain unknown. This hampers efforts to identify mechanistic targets in order to optimize treatment precision and potency. Funded within the NIH Science of Behavior Change (SOBC) Research Network, the 2-phased ENGAGE research project applies an experimental precision medicine approach to address this gap. The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy. This therapy combines a video-based behavioral weight loss program and problem-solving therapy for depression, with as-needed intensification of antidepressant medications, and its clinical effectiveness was demonstrated within a parent randomized clinical trial. Here, we describe the ENGAGE Phase 2 (ENGAGE-2) study protocol which builds on Phase 1 in 2 ways: (1) pilot testing of an motivational interviewing-enhanced, integrated behavior therapy in an independent, primarily minority patient sample, and (2) evaluation of a priori defined neural targets, specifically the negative affect (threat and sadness) circuits which demonstrated engagement and malleability in Phase 1, as mediators of therapeutic outcomes. Additionally, the Phase 2 study includes a conceptual and methodological extension to explore the role of microbiome-gut-brain and systemic immunological pathways in integrated behavioral treatment of obesity and depression. This protocol paper documents the conceptualization, design and the transdisciplinary methodologies in ENGAGE-2, which can inform future clinical and translational research in experimental precision medicine for behavior change and chronic disease management. Trial registration: ClinicalTrials.gov #NCT 03,841,682.
AB - Despite evidence for effective integrated behavior therapy for treating comorbid obesity and depression, treatment response is highly variable and the underlying neurobiological mechanisms remain unknown. This hampers efforts to identify mechanistic targets in order to optimize treatment precision and potency. Funded within the NIH Science of Behavior Change (SOBC) Research Network, the 2-phased ENGAGE research project applies an experimental precision medicine approach to address this gap. The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy. This therapy combines a video-based behavioral weight loss program and problem-solving therapy for depression, with as-needed intensification of antidepressant medications, and its clinical effectiveness was demonstrated within a parent randomized clinical trial. Here, we describe the ENGAGE Phase 2 (ENGAGE-2) study protocol which builds on Phase 1 in 2 ways: (1) pilot testing of an motivational interviewing-enhanced, integrated behavior therapy in an independent, primarily minority patient sample, and (2) evaluation of a priori defined neural targets, specifically the negative affect (threat and sadness) circuits which demonstrated engagement and malleability in Phase 1, as mediators of therapeutic outcomes. Additionally, the Phase 2 study includes a conceptual and methodological extension to explore the role of microbiome-gut-brain and systemic immunological pathways in integrated behavioral treatment of obesity and depression. This protocol paper documents the conceptualization, design and the transdisciplinary methodologies in ENGAGE-2, which can inform future clinical and translational research in experimental precision medicine for behavior change and chronic disease management. Trial registration: ClinicalTrials.gov #NCT 03,841,682.
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UR - http://www.scopus.com/inward/citedby.url?scp=85087386320&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2020.106072
DO - 10.1016/j.cct.2020.106072
M3 - Article
C2 - 32621905
AN - SCOPUS:85087386320
VL - 95
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
SN - 1551-7144
M1 - 106072
ER -
