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1. The STEPWISE study: study protocol for a smartphone-based exercise solution for people with Parkinson’s Disease (randomized controlled trial)

Author

Sabine Schootemeijer, Nienke M. de Vries, Eric A. Macklin, Kit C.B. Roes, Hilde Joosten, Larsson Omberg, Alberto Ascherio, Michael A. Schwarzschild, and Bastiaan R. Bloem

Subjects
Physical activity, Exercise, Parkinson’s disease, Smartphone, Step count, Randomized controlled trial, Neurology. Diseases of the nervous system, RC346-429
Abstract

Abstract Background Exercise has various health benefits for people with Parkinson’s disease (PD). However, implementing exercise into daily life and long-term adherence remain challenging. To increase a sustainable engagement with physical activity of people with PD, interventions that are motivating, accessible, and scalable are needed. We primarily aim to investigate whether a smartphone app (STEPWISE app) can increase physical activity (i.e., step count) in people with PD over one year. Our second aim is to investigate the potential effects of the intervention on physical fitness, and motor- and non-motor function. Our third aim is to explore whether there is a dose-response relationship between volume of physical activity and our secondary endpoints. Methods STEPWISE is a double-blind, randomized controlled trial. We aim to include 452 Dutch people with PD who can walk independently (Hoehn & Yahr stages 1–3) and who do not take more than 7,000 steps per day prior to inclusion. Physical activity levels are measured as step counts on the participant’s own smartphone and scaled as percentage of each participant’s baseline. Participants are randomly assigned to an active control group with an increase of 5–20% (active controls) or any of the three intervention arms with increases of 25–100% (intermediate dose), 50–200% (large dose), or 100–400% (very large dose). The primary endpoint is change in step count as measured by the STEPWISE smartphone app from baseline to 52 weeks. For our primary aim, we will evaluate the between-group difference in average daily step count change from baseline to 52 weeks. For our second aim, measures of physical fitness, and motor- and non-motor function are included. For our third aim, we will associate 52-week changes in step count with 52-week changes in secondary outcomes. Discussion This trial evaluates the potential of a smartphone-based intervention to increase activity levels in people with PD. We envision that motivational apps will increase adherence to physical activity recommendations and could permit conduct of remote clinical trials of exercise for people with PD or those at risk of PD. Trial registration ClinicalTrials.gov; NCT04848077; 19/04/2021. Clinicaltrials.gov/ct2/show/NCT04848077.

Published
2023
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2. Nutritional counseling with or without mobile health technology: a randomized open-label standard-of-care-controlled trial in ALS

Author

Anne Marie Wills, Jamie Garry, Jane Hubbard, Taylor Mezoian, Christopher T. Breen, Courtney Ortiz-Miller, Paige Nalipinski, Stacey Sullivan, James D. Berry, Merit Cudkowicz, Sabrina Paganoni, James Chan, and Eric A. Macklin

Subjects
Amyotrophic lateral sclerosis, ALS, Neurodegenerative disease, Mobile health technology, mHealth, Nutrition, Neurology. Diseases of the nervous system, RC346-429
Abstract

Abstract Background Nutritional status is an important prognostic factor in Amyotrophic Lateral Sclerosis (ALS). We wished to study the safety, tolerability and efficacy of nutritional counseling with or without an mHealth application to maintain or increase body weight in ALS, compared to standard care. Methods In this randomized open-label, standard-of-care-controlled, single-center clinical trial, we randomly assigned adults with ALS to one of three nutritional interventions: counseling by their physician or nurse (“standard care”), counseling by a registered dietitian (RD) (“in-person”), or counseling supported by a mHealth app (“mHealth”). Both intervention arms received tailored nutrition recommendations and recorded dietary intake and weight biweekly (mHealth) or monthly (in-person). The primary outcome of weight and secondary and tertiary outcomes of calorie intake, ALSFRS-R, and quality of life (QOL) were recorded at each clinic visit and analyzed in an ITT mixed model analysis. Results A total of 88 participants were enrolled of whom 78 were included in this analysis. The three arms were well-balanced except for excess males in the mHealth arm and greater weight lost at baseline in the in-person arm. Participants in the mHealth arm increased their calorie intake at month 3 to an average of 94% (95% CI: 85, 103) of recommended calories, compared to 81% (95% CI: 72, 91, p = 0.06 vs. mHealth) in the standard care arm. After 6 months, calorie intake was not different among the three arms. Overall weight was stable across all three groups. QOL scores in the mHealth arm were stable over 3 months (0.3 points, 95% CI: − 1.7, 2.2) compared to worsening in standard care (− 2.1 points, 95% CI: − 4.0, − 0.2, p = 0.09 vs. mHealth), but all scores declined by 6 months. ALSFRS-R total scores declined by an average of − 2.6 points (95% CI: − 5.1, − 0.1) over 6 months in the mHealth arm (p = 0.13 vs. standard care) compared to − 5.8 points (95% CI: − 8.2, − 3.4, p = 0.74 vs. standard care) in the in-person and − 5.2 points (95% CI: − 7.6, − 2.9) in the standard care arm. Conclusions Nutritional counseling by a registered dietitian (with or without support by an mHealth app) is safe but did not maintain weight significantly better than standard care in ALS patients. Trial registration https://clinicaltrials.gov/ identifier NCT02418546. Registered April 16, 2015.

Published
2019
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3. Results of a feasibility randomized controlled trial (RCT) of the Toolkit for Optimal Recovery (TOR): a live video program to prevent chronic pain in at-risk adults with orthopedic injuries

Author

Ana-Maria Vranceanu, Cale Jacobs, Ann Lin, Jonathan Greenberg, Christopher J. Funes, Mitchel B. Harris, Marilyn M. Heng, Eric A. Macklin, and David Ring

Subjects
Orthopedic musculoskeletal injury, Prevention of chronic pain, Physical function, Intervention, Video, Telehealth, Medicine (General), R5-920
Abstract

Abstract Background Orthopedic injuries are the leading cause of hospital admissions in the USA, and many of these patients transition into chronic pain. Currently, there are no evidence-based interventions targeting prevention of chronic pain in patients with orthopedic injuries. We iteratively developed a four-session intervention “The Toolkit for Optimal Recovery” (TOR) which we plan to subsequently test for efficacy in a phase III hybrid efficacy-effectiveness multi-site clinical trial. In order to prevent methodological weaknesses in the subsequent trial, we conducted a feasibility pilot to evaluate the TOR delivered via secure live video versus usual care (UC) in patients with orthopedic injuries from an urban, level I trauma clinic, who screen in as at risk for chronic pain and disability. We tested the feasibility of recruitment, acceptability of screening, and randomization methods; acceptability of the intervention, treatment adherence, and treatment fidelity; satisfaction with the intervention; feasibility of the assessment process at all time points; acceptability of outcome measures for the definitive trial; and within-treatment effect sizes. Methods We aimed to recruit 50–60 participants, randomize, and retain them for ~ 4 months. Assessments were done electronically via REDCap at baseline, post-intervention (approximately 5 weeks after baseline), and 3 months later. We followed procedures we intend to implement in the full-scale hybrid efficacy-effectiveness trial. Results We recruited 54 participants and found that randomization and data collection procedures were generally acceptable. The majority of participants were white, educated, and employed. Warm hand-off referrals were more effective than research assistants directly approaching patients for participation without their providers’ engagement. Feasibility of recruitment, acceptability of screening, and randomization were good. Satisfaction with the program, adherence to treatment sessions, and treatment fidelity were all high. There were no technical issues associated with the live video delivery of the TOR. There was minimal missing data and outcome measures were deemed appropriate. Effect sizes for improvement after participation in TOR were moderate to large. There were many lessons learned for future trials. Conclusions This study provided evidence of the feasibility of the planned hybrid efficacy-effectiveness trial design when implemented at our home institution. Establishing feasibility of the intervention and study procedures at other trauma centers with more diverse patient populations and different clinical practices is required before a multi-site phase III efficacy-effectiveness trial. Trial registration ClinicalTrials.gov ID: NCT03405610. Registered on January 28, 2018—retrospectively registered.

Published
2019
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4. World Congress Integrative Medicine & Health 2017: part two

Author

Carolyn Ee, Sharmala Thuraisingam, Marie Pirotta, Simon French, Charlie Xue, Helena Teede, Agnete E. Kristoffersen, Fuschia Sirois, Trine Stub, Jennifer Engler, Stefanie Joos, Corina Güthlin, Jennifer Felenda, Christiane Beckmann, Florian Stintzing, Roni Evans, Gert Bronfort, Daniel Keefe, Anna Taberko, Linda Hanson, Alex Haley, Haiwei Ma, Joseph Jolton, Lana Yarosh, Francis Keefe, Jung Nam, Liwanag Ojala, Mary J. Kreitzer, Careen Fink, Karin Kraft, Andrew Flower, George Lewith, Kim Harman, Beth Stuart, Felicity L. Bishop, Jane Frawley, Lilla Füleki, Eva Kiss, Tamas Vancsik, Tibor Krenacs, Martha Funabashi, Katherine A. Pohlman, Silvano Mior, Haymo Thiel, Michael D. Hill, David J. Cassidy, Michael Westaway, Jerome Yager, Eric Hurwitz, Gregory N. Kawchuk, Maeve O’Beirne, Sunita Vohra, Isabelle Gaboury, Chantal Morin, Katharina Gaertner, Loredana Torchetti, Martin Frei-Erb, Michael Kundi, Michael Frass, Eugenia Gallo, Valentina Maggini, Mattia Comite, Francesco Sofi, Sonia Baccetti, Alfredo Vannacci, Mariella Di Stefano, Maria V. Monechi, Luigi Gori, Elio Rossi, Fabio Firenzuoli, Rocco D. Mediati, Giovanna Ballerini, Paula Gardiner, Anna S. Lestoquoy, Lily Negash, Sarah Stillman, Prachi Shah, Jane Liebschutz, Pamela Adelstein, Christine Farrell-Riley, Ivy Brackup, Brian Penti, Robert Saper, Isabel Giralt Sampedro, Gilda Carvajal, Andreas Gleiss, Marie M. Gross, Dorothea Brendlin, Jonas Röttger, Wiebke Stritter, Georg Seifert, Noelle Grzanna, Rainer Stange, Peter W. Guendling, Wen Gu, Yan Lu, Jie Wang, Chengcheng Zhang, Hua Bai, Yuxi He, Xiaoxu Zhang, Zhengju Zhang, Dali Wang, Fengxian Meng, Alexander Hagel, Heinz Albrecht, Claudia Vollbracht, Wolfgang Dauth, Wolfgang Hagel, Francesco Vitali, Ingo Ganzleben, Hans Schultis, Peter Konturek, Jürgen Stein, Markus Neurath, Martin Raithel, Bianka Krick, Heidemarie Haller, Petra Klose, Gustav Dobos, Sherko Kümmel, Holger Cramer, Felix J. Saha, Anna Kowoll, Barbara Ebner, Bettina Berger, Kyung-Eun Choi, Lisha He, Han Wang, X. He, C. Gu, Y. Zhang, Linhua Zhao, Xiaolin Tong, Xinhui He, Chengjuan Gu, Ying Zhang, Robin S. T. Ho, Vincent C. H. Chung, Xinyin Wu, Charlene H. L. Wong, Justin C. Y. Wu, Samuel Y. S. Wong, Alexander Y. L. Lau, Regina W. S. Sit, Wendy Wong, Michelle Holmes, Felicity Bishop, Lynn Calman, Dave Newell, Jonathan Field, Win L. Htut, Dongwoon Han, Da I. Choi, Soo J. Choi, Ha Y. Kim, Jung H. Hwang, Ching W. Huang, Bo H. Jang, Fang P. Chen, Seong G. Ko, Wenjing Huang, De Jin, Fengmei Lian, Soobin Jang, Kyeong H. Kim, Eun K. Lee, Seung H. Sun, Ho Y. Go, Youme Ko, Sunju Park, Yong C. Shin, Hubert Janik, Natalie Greiffenhagen, Jürgen Bolte, Mariusz Jaworski, Miroslawa Adamus, Aleksandra Dobrzynska, Michael Jeitler, Jessica Jaspers, Christel von Scheidt, Barbara Koch, Andreas Michalsen, Nico Steckhan, Christian Kessler, Wen-jing Huang, Bing Pang, Feng-Mei Lian, Miek Jong, Erik Baars, Anja Glockmann, Harald Hamre, Mosaburo Kainuma, Aya Murakami, Toshio Kubota, Daisuke Kobayashi, Yasuhiro Sumoto, Norihiro Furusyo, Shin-Ichi Ando, Takao Shimazoe, Olaf Kelber, S. Verjee, Eva Gorgus, Dieter Schrenk, Kathi Kemper, Ellie Hill, Nisha Rao, Gregg Gascon, John Mahan, Gunver Kienle, Jörg Dietrich, Claudia Schmoor, Roman Huber, Weon H. Kim, Mansoor Ahmed, Luzhu He, Jung Hye Hwang, Nora Meggyeshazi, Csaba Kovago, Anne K. Klaus, Roland Zerm, Danilo Pranga, Thomas Ostermann, Marcus Reif, Hans Broder von Laue, Benno Brinkhaus, Matthias Kröz, Daniela Rodrigues Recchia, Hans B. von Laue, Christien T. Klein-Laansma, Mats Jong, Cornelia von Hagens, Jean P. Jansen, Herman van Wietmarschen, Miek C. Jong, Seung-Ho Sun, Ho-Yeon Go, Chan-Yong Jeon, Yun-Kyung Song, Seong-Gyu Ko, Anna K. Koch, Sybille Rabsilber, Romy Lauche, Jost Langhorst, Milena Trifunovic-Koenig, Evi Koster, Diana Delnoij, Lena Kroll, Kathrin Weiss, Ai Kubo, Sarah Hendlish, Andrea Altschuler, Nancy Connolly, Andy Avins, Jon Wardle, David Lee, David Sibbritt, Jon Adams, Crystal Park, Gita Mishra, Johann Lechner, Inseon Lee, Younbyoung Chae, Jisu Lee, Seung H. Cho, Yujin Choi, Jee Y. Lee, Han S. Ryu, Sung S. Yoon, Hye K. Oh, Lyun K. Hyun, Jin O. Kim, Seong W. Yoon, Ju-Yeon Lee, Sang-Hoon Shin, Min Jang, Indra Müller, So-Hyun Janson Park, Lance Laird, Suzanne Mitchell, Xiaofei Li, Yunhui Wang, Jianhua Zhen, He Yu, Tiegang Liu, Xiaohong Gu, Hui Liu, Weiguo Ma, Xuezheng Shang, Yu Bai, Wei Liu, Collin Rooney, Amos Smith, Shirlene Lopes, Marcelo Demarzo, Maria do Patrocínio Nunes, Peter Lorenz, Carsten Gründemann, Miriam Heinrich, Manuel Garcia-Käufer, Franziska Grunewald, Silke Messerschmidt, Anja Herrick, Kim Gruber, Matthias Knödler, Carmen Steinborn, Taoying Lu, Lixin Wang, Darong Wu, Christina M Luberto, Daniel L. Hall, Emma Chad-Friedman, Suzanne Lechner, Elyse R. Park, Christina M. Luberto, Elyse Park, Janice Goodman, Sonja Luer, Matthias Heri, Klaus von Ammon, Ida Landini, Andrea Lapucci, Stefania Nobili, Enrico Mini, Clare McDermott, Selwyn Richards, Diane Cox, Sarah Frossell, Geraldine Leydon, Caroline Eyles, Hilly Raphael, Rachael Rogers, Michelle Selby, Charlotte Adler, Jo Allam, Xiangwei Bu, Honghong Zhang, Jianpeng Zhang, Michael Mikolasek, Jonas Berg, Claudia Witt, Jürgen Barth, Ivan Miskulin, Zdenka Lalic, Maja Miskulin, Albina Dumic, Damir Sebo, Aleksandar Vcev, Nasr A. A. Mohammed, Soo Jeung Choi, Hyea Bin Im, Anwesha Mukherjee, Amit Kandhare, Subhash Bodhankar, Prasad Thakurdesai, Niki Munk, Erica Evans, Amanda Froman, Matthew Kline, Matthew J. Bair, Frauke Musial, Terje Alræk, Harald J. Hamre, Lars Björkman, Vinjar M. Fønnebø, Feng-mei Lian, Qing Ni, Xiao-lin Tong, Xin-long Li, Wen-ke Liu, Shuo Feng, Xi-yan Zhao, Yu-jiao Zheng, Xue-min Zhao, Yi-qun Lin, Tian-yu Zhao, Xi-Yan Zhao, Hui Che Phd, Chen Zhang, Feng Liu, Lin-hua Zhao, Ru Ye, Cheng-juan Gu, Wenbo Peng, Diana De Carvalho, Mohamed El-Bayoumi, Bob Haig, Kimbalin Kelly, Darrell J. Wade, Emanuela Portalupi, Giampietro Gobo, Luigi Bellavita, Chiara Guglielmetti, Christa Raak, Myriam Teuber, Friedrich Molsberger, Ulrich von Rath, Ulrike Reichelt, Uta Schwanebeck, Sabine Zeil, Christian Vogelberg, Dolores Rodríguez Veintimilla, Guerrero Tapia Mery, Marisol Maldonado Villavicencio, Sandra Herrera Moran, Christian Sachse, Peter W Gündlin, Monirsadat Sahebkarkhorasani, Hoda Azizi, Dania Schumann, Tobias Sundberg, Matthew J. Leach, Susana Seca, Henry Greten, Sugir Selliah, Anu Shakya, Ha Yun Kim, Hyea B. Im, Anna Sherbakova, Gudrun Ulrich-Merzenich, Heba Abdel-Aziz, Erica Sibinga, Lindsey Webb, Jonathan Ellen, Kari Skrautvol, Dagfinn Nåden, Rhayun Song, Weronika Grabowska, Kamila Osypiuk, Gloria V. Diaz, Paolo Bonato, Moonkyoung Park, Jeffrey Hausdorff, Michael Fox, Lewis R. Sudarsky, Daniel Tarsy, James Novakowski, Eric A. Macklin, Peter M. Wayne, Inok Hwang, Sukhee Ahn, Myung-Ah Lee, Min K. Sohn, Oleg Sorokin, Dagmar Heydeck, Astrid Borchert, Christoph-Daniel Hohmann, Harmut Kühn, Clemens Kirschbaum, Tobias Stalder, Barbara Stöckigt, Michael Teut, Ralf Suhr, Daniela Sulmann, Chris Streeter, Patrica Gerbarg, Marisa Silveri, Richard Brown, John Jensen, Britta Rutert, Angelika Eggert, Alfred Längler, Christine Holmberg, Jin Sun, Xin Deng, Wen-Yuan Li, Bin Wen, Nicola Robinson, Jian-Ping Liu, Hyun K. Sung, Narae Yang, Seon M. Shin, Hee Jung, Young J. Kim, Woo S. Jung, Tae Y. Park, Kiyoshi Suzuki, Toshinori Ito, Seiya Uchida, Seika Kamohara, Naoya Ono, Mitsuyuki Takamura, Ayumu Yokochi, Kazuo Maruyama, Patricio Tapia, Katarzyna Thabaut, Anja Thronicke, Megan Steele, Harald Matthes, Cornelia Herbstreit, Friedemann Schad, Jiaxing Tian, Libo Yang, Tian Tian, Hewei Zhang, Xia Tian, CongCong Wang, Qian Yun Chai, Lijuan Zhang, Ruyu Xia, Na Huang, Yutong Fei, Jianpin Liu, Natalie Trent, Mindy Miraglia, Jeffrey Dusek, Edi Pasalis, Sat B. Khalsa, Milena Trifunovic-König, Anna Koch, Lisa Uebelacker, Geoffrey Tremont, Lee Gillette, Gary Epstein-Lubow, David Strong, Ana Abrantes, Audrey Tyrka, Tanya Tran, Brandon Gaudiano, Ivan Miller, Gerhild Ullmann, Yuhua Li, Sujata Vaidya, Vinod Marathe, Ana C. Vale, Jacquelyne Motta, Fabíola Donadão, Angela C. Valente, Luana C. Carvalho Valente, Ricardo Ghelman, Dusan Vesovic, Dragan Jevdic, Aleksandar Jevdic, Katarina Jevdic, Mihael Djacic, Dragica Letic, Drago Bozic, Marija Markovic, Slobodan Dunjic, Gordana Ruscuklic, Dezire Baksa, Kenan Vrca, Ann Vincent, Dietlind Wahner-Roedler, Mary Whipple, Maria M. Vogelius, Iris Friesecke, Peter W. Gündling, Saswati Mahapatra, Rebecca Hynes, Kimberly Van Rooy, Sherry Looker, Aditya Ghosh, Brent Bauer, Susanne Cutshall, Harald Walach, Ana Borges Flores, Michael Ofner, Andreas Kastner, Gerhard Schwarzl, Hermann Schwameder, Nathalie Alexander, Gerda Strutzenberger, Xianwei Bu, Jianping Zhang, Shang Wang, Jinfeng Shi, Yu Hao, Jun Wu, Zeji Qiu, Yuh-Hai Wang, Chi-Jung Lou, Sam Watts, Peter Wayne, Gloria Vergara-Diaz, Brian Gow, Jose Miranda, Lewis Sudarsky, Eric Macklin, Kathrin Wode, Jenny Bergqvist, Britt-Marie Bernhardsson, Johanna Hök Nordberg, Lena Sharp, Roger Henriksson, Yeonju Woo, Min K. Hyun, Hao Wu, Tian-Fang Wang, Yan Zhao, Yu Wei, Lei Tian, Lei He, Xue Wang, Ruohan Wu, Mei Han, Patrina H. Y. Caldwell, Shigang Liu, Jing Zhang, Jianping Liu, Qianyun Chai, Zhongning Guo, Congcong Wang, Zhijun Liu, Xun Li, I. J. Yang, V. Ruberio Lincha, S. H. Ahn, D. U. Lee, H. M. Shin, Lu Yang, N. Yang, H. Sung, S. M. Shin, H. Y. Go, H. Jung, Y. Kim, T. Y. Park, Angela Yap, Yu H. Kwan, Chuen S. Tan, Syed Ibrahim, Seng B. Ang, Alfred Yayi, Jeong E. Yoo, Ho R. Yoo, Sae B. Jang, Hye L. Lee, Ala’a Youssef, Shahira Ezzat, Amira Abdel Motaal, Hesham El-Askary, Xiaotong Yu, Yashan Cui, Younghee Yun, Jin-Hyang Ahn, Bo-Hyung Jang, Kyu-Seok Kim, Inhwa Choi, Augustina Glinz, Fadime ten Brink, Arnd Büssing, Christoph Gutenbrunner, Bert Helbrecht, Tiesheng Fang, Fengxion Meng, Zhiming Shen, Ruixin Zhang, Fan Wu, Ming Li, Xinyun Xuan, Xueyong Shen, Ke Ren, Brian Berman, Zian Zheng, Yuxiang Wan, Xueyan Ma, Fei Dong, Suzie Zick, Richard Harris, Go E. Bae, Jung N. Kwon, Hye Y. Lee, Jong K. Nam, Sang D. Lee, Dong H. Lee, Ji Y. Han, Young J. Yun, Ji H. Lee, Hye L. Park, Seong H. Park, Chiara Bocci, Giovanni B. Ivaldi, Ilaria Vietti, Ilaria Meaglia, Marta Guffi, Rubina Ruggiero, Marita Gualea, Emanuela Longa, Massimo Bonucci, Sarah Croke, Lourdes Diaz Rodriguez, Juan C. Caracuel-Martínez, Manuel F. Fajardo-Rodríguez, Angélica Ariza-García, Francisca García-De la Fuente, Manuel Arroyo-Morales, Maria S. Estrems, Vicente G. Gómez, Mónica Valero Sabater, Rosaria Ferreri, Simonetta Bernardini, Roberto Pulcri, Franco Cracolici, Massimo Rinaldi, Claudio Porciani, Peter Fisher, John Hughes, Ariadna Mendoza, Hugh MacPherson, Jacqueline Filshie, Antonia Di Francesco, Alberto Bernardini, Monica Messe, Vincenzo Primitivo, Piera A. Iasella, Monica Taminato, Jaqueline Do Carmo Alcantara, Katia R. De Oliveira, Debora C. De Azevedo Rodrigues, Juliana R. Campana Mumme, Olga K. Matsumoto Sunakozawa, Vicente Odone Filho, Joshua Goldenberg, Andrew Day, Masa Sasagawa, Lesley Ward, Kieran Cooley, Thora Gunnarsdottir, Ingibjorg Hjaltadottir, Mahdie Hajimonfarednejad, Nicole Hannan, Rut Hellsing, Susanne Andermo, Maria Arman, Iris von Hörsten, Patricia Vásquez Torrielo, Carmen L. Andrade Vilaró, Francisco Cerda Cabrera, Henny Hui, Eric Ziea, Dora Tsui, Joyce Hsieh, Christine Lam, Edith Chan, Mark P. Jensen, Samuel L. Battalio, Joy Chan, Karlyn A. Edwards, Kevin J. Gertz, Melissa A. Day, Leslie H. Sherlin, Dawn M. Ehde, Bo-Hyoung Jang, Anja Börner, Jihong Lee, Boram Lee, Gyu T. Chang, Alejandra Menassa, Yoshiharu Motoo, Jürgen Müller, Sabine Rabini, Bettina Vinson, Martin Storr, Martin Niemeijer, Joop Hoekman, Wied Ruijssenaaars, Faith C. Njoku, Arne J. Norheim, Filiz Okumus, and Halime Oncu-Celik

Subjects
Other systems of medicine, RZ201-999
Published
2017
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5. Nutritional counseling with or without mobile health technology: a randomized open-label standard-of-care-controlled trial in ALS

Author

Jamie Garry, James D. Berry, Stacey Sullivan, Jane Hubbard, Christopher T. Breen, Anne-Marie Wills, Sabrina Paganoni, Taylor Mezoian, Merit Cudkowicz, Courtney Ortiz-Miller, Paige Nalipinski, James Chan, and Eric A. Macklin

Subjects
Adult, Counseling, Male, medicine.medical_specialty, Calorie, Mobile health technology, Neurodegenerative disease, lcsh:RC346-429, law.invention, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Randomized controlled trial, law, medicine, Humans, 030212 general & internal medicine, mHealth, lcsh:Neurology. Diseases of the nervous system, Nutrition, business.industry, Health technology, Nutritional counseling, General Medicine, Amyotrophic lateral sclerosis, Telemedicine, 3. Good health, Clinical trial, Tolerability, Quality of Life, Physical therapy, Female, Neurology (clinical), ALS, business, 030217 neurology & neurosurgery, Research Article
Abstract

Background: Nutritional status is an important prognostic factor in Amyotrophic Lateral Sclerosis (ALS). We wished to study the safety, tolerability and efficacy of nutritional counseling with or without an mHealth application to maintain or increase body weight in ALS, compared to standard care. Methods: In this randomized open-label, standard-of-care-controlled, single-center clinical trial, we randomly assigned adults with ALS to one of three nutritional interventions: counseling by their physician or nurse (“standard care”), counseling by a registered dietitian (RD) (“in-person”), or counseling supported by a mHealth app (“mHealth”). Both intervention arms received tailored nutrition recommendations and recorded dietary intake and weight biweekly (mHealth) or monthly (in-person). The primary outcome of weight and secondary and tertiary outcomes of calorie intake, ALSFRS-R, and quality of life (QOL) were recorded at each clinic visit and analyzed in an ITT mixed model analysis. Results: A total of 88 participants were enrolled of whom 78 were included in this analysis. The three arms were well-balanced except for excess males in the mHealth arm and greater weight lost at baseline in the in-person arm. Participants in the mHealth arm increased their calorie intake at month 3 to an average of 94% (95% CI: 85, 103) of recommended calories, compared to 81% (95% CI: 72, 91, p= 0.06 vs. mHealth) in the standard care arm. After 6 months, calorie intake and change in weight was not different among the three arms. QOL scores in the mHealth arm were stable over three months (0.3 points, 95% CI: -1.7, 2.2) compared to worsening in standard care (-2.1 points, 95% CI: -4.0, -0.2, p = 0.09 vs. mHealth), but all scores declined by six months. ALSFRS-R total scores declined by an average of -2.6 points (95% CI: -5.1, -0.1) over six months in the mHealth arm (p=0.13 vs. standard care) compared to -5.8 points (95% CI: -8.2, -3.4, p=0.74 vs. standard care) in the in-person and -5.2 points (95% CI: -7.6, -2.9) in the standard care arm. Conclusions: Nutritional counseling is safe but did not increase weight compared to standard care in ALS patients. Trial Registration: Clinicaltrials.gov identifier NCT02418546. Registered April 16, 2015. Keywords: Amyotrophic Lateral Sclerosis, ALS, Neurodegenerative disease, mobile health technology, mHealth, nutrition, nutritional counseling, randomized controlled trial

Published
2019

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