How to Cite IWQOL-Lite-Clinical Trials Version©

Kolotkin RL, Williams VSL, Ervin CM, Williams N, Meincke HH, Qin S, von Huth Smith L, Fehnel SE. Validation of a new measure of quality of life in obesity trials: Impact of Weight on Quality of Life-Lite Clinical Trials Version. Clin Obes. 2019 Jun;9(3):e12310. doi: 10.1111/cob.12310.

IWQOL-Lite-Clinical Trials Publications

 Kolotkin, R.L., Ervin, C.M., Meincke, H.H., Højbjerre L., Fehnel, S.E. Development of a clinical trials version of the Impact of Weight on Quality of Life-Lite questionnaire (IWQOL-Lite Clinical Trials Version): Results from two qualitative studies. Clinical Obesity, 2017 Oct;7(5):290-299. doi: 10.1111/cob.12197. 
 
Kolotkin, R.L., Williams, V.S.L., Ervin, C.M., Williams, N., Meincke, H.H., Qin, S., von Huth Smith, L., Fehnel, S.E. Validation of a new measure of quality of life in obesity trials: Impact of Weight on Quality of Life-Lite Clinical Trials Version. Clinical Obesity, 2019 Jun;9(3):e12310. doi: 10.1111/cob.12310. View supporting tables for this publication.

Rosenstock J, Allison D, Birkenfeld AL, et al. Effect of additional oral semaglutide vs sitagliptin on glycated hemoglobin in adults with type 2 diabetes uncontrolled with metformin alone or with sulfonylurea: the PIONEER 3 randomized clinical trial. JAMA. 2019;321 (15):1466–1480, Supplement 1.

Zinman B, Aroda VR, Buse JB, Cariou B, Harris SB, Hoff ST, Pedersen KB, Tarp-Johansen MJ, Araki E; PIONEER 8 Investigators. Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial. Diabetes Care. 2019 Dec;42(12):2262-2271. doi: 10.2337/dc19-0898. Epub 2019 Sep 17. PMID: 31530667; PMCID: PMC7364672.
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Wadden, T.A., Tronieri, J.S., Sugimoto, D., Lund, M.T., Auerbach, P., Jensen, C., Rubino, D. Liraglutide 3.0 mg and Intensive Behavioral Therapy (IBT) for Obesity in Primary Care: The SCALE IBT Randomized Controlled Trial. Obesity (Silver Spring). 2020 Mar;28(3):529-536. doi: 10.1002/oby.22726/.

Garvey, W.T., Birkenfeld, A.L., Dicker, D., et al. Efficacy and Safety of Liraglutide 3.0 mg in Individuals With Overweight or Obesity and Type 2 Diabetes Treated With Basal Insulin: The SCALE Insulin Randomized Controlled Trial. Diabetes Care. 2020 Mar 5. pii: dc191745. doi: 10.2337/dc19-1745. 

Kushner RF, Calanna S, Davies M, et al. Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity (Silver Spring). 2020;28(6):1050-1061. doi:10.1002/oby.22794

Wilding, JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med 2021; 384 (11): 989-1002.
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Davies M, Færch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I; STEP 2 Study Group. Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet. 2021 Mar 2:S0140-6736(21)00213-0. doi: 10.1016/S0140-6736(21)00213-0.
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Wharton, S, Bjorner, JB, Kushner, RF, et al. Semaglutide 2.4 mg Once Weekly Improves Patient-Reported Outcome Measures of Physical Functioning in Adults with Overweight or Obesity in the STEP 1 Trial. Obesity Facts; 2021;15 (suppl 1): 52-53.

Rubino, DM, Bjorner, JB, Kushner, RF, et al. Beneficial Effect of Semaglutide 2.4 mg Once Weekly on Patient-Reported Outcome Measures of Weight-Related and Health-Related Quality of Life in Adults With Overweight or Obesity in the STEP 1 Trial. Obesity Facts; 2021;15 (suppl 1): 118-119.

Wharton, S, Meincke, HH, Kushner, RF, Oral, TK, Pedersen, S, Rubino, D, Ryan, DH, Zeuthen, N, Kolotkin, RL. 85-OR: Semaglutide 2.4 mg Improves Patient Reported Outcome Measures of Physical Functioning in Adults with Overweight/Obesity and Type 2 Diabetes in the STEP 2 Trial. Diabetes 1 June 2021; 70 (Supplement_1): 85–OR. https://doi-org.proxy.lib.duke.edu/10.2337/db21-85-OR

Rubino, DM,  Færch, L,  Meincke, H,  et al. (2021). Semaglutide 2.4 mg Improves Health-Related Quality of Life in Adults with Overweight/Obesity and Type 2 Diabetes in the STEP 2 Trial. Diabetes. 70. 84-OR. 10.2337/db21-84-OR. 

Kolotkin, RL, Williams, VSL, von Huth Smith, L, et al. Confirmatory psychometric evaluations of the Impact of Weight on Quality of Life–Lite Clinical Trials Version (IWQOL-Lite-CT). Clinical Obesity. 2021 Jul 22:e12477. doi: 10.1111/cob.12477.

Kadowaki T, Isendahl J, Khalid U, et al. Semaglutide once a week in adults with overweight or obesity, with or without type 2 diabetes in an east Asian population (STEP 6): a randomised, double-blind, double-dummy, placebo-controlled, phase 3a trial. Lancet Diabetes Endocrinology 2022; published online Feb 4. https://doi. org/10.1016/S2213-8587(22)00008-0.

​Boye, K, Thieu, V, Yu, M, Sapin, H. Higher weight loss is associated with improved quality of life in patients with type 2 diabetes—SURPASS program. Diabetes 2022;71(Supplement_1):47-LB. https://doi.org/10.2337/db22-47-LB. 

Boye, KS, Yu, M, Liu, B, et al. Patient reported outcomes for tirzepatide versus semaglutide in participants with T2D from the SURPASS-2 Trial. Diabetes Research and Clinical Practice. Volume 186; Supplement 1, 109697, April 01, 2022. https://www.diabetesresearchclinicalpractice.com/article/S0168-8227(22)00509-5/fulltext

​le Roux CW, Zhang S, Aronne LJ, et al. Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program. Obesity (Silver Spring). 2022;1‐15. doi:10.1002/oby.23612

​Poon, JL., Marshall, C., Johnson, C. et al. A qualitative study to examine meaningful change in physical function associated with weight-loss. Qual Life Res 32, 1329–1340 (2023). https://doi.org/10.1007/s11136-022-03191-2

Kolotkin, RL, Jeppesen, OK, Baker-Knight, J, Lee, SY, Tokita, A, Kadowaki, T. Effect of once-weekly subcutaneous semaglutide 2.4 mg on weight- and health-related quality of life in an East Asian population: Patient-reported outcomes from the STEP 6 trial. Clinical Obesity. 2023; 13( 4):e12589. doi:10.1111/cob.12589. 
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​Lee, C, Boye, K, Thieu, V, Allen, S, Dong, W, Sapin, H. 752-P: Improved BMI Category Is Associated with Better Patient-Reported Outcomes (PROs) in Adults with T2D Treated with Tirzepatide. Diabetes 20 June 2023; 72 (Supplement_1): 752–P. https://doi.org/10.2337/db23-752-P

Knop FK, Aroda VR, do Vale RD, Holst-Hansen T, Laursen PN, Rosenstock J, Rubino DM, Garvey WT; OASIS 1 Investigators. Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 23:S0140-6736(23)01185-6. doi: 10.1016/S0140-6736(23)01185-6. Epub ahead of print. PMID: 37385278.

Zhang R, Hou QC, Li BH, Deng L, Yang YM, Li TX, Yao XQ, Yang LL, Lin XL, Liao YQ, Wang L, Liu YP, Tan J, Wan ZW, Shuai P. Efficacy and safety of subcutaneous semaglutide in adults with overweight or obese: a subgroup meta-analysis of randomized controlled trials. Front Endocrinol (Lausanne). 2023 Jun 26;14:1132004. doi: 10.3389/fendo.2023.1132004. PMID: 37455913; PMCID: PMC10338217.

Gelhorn HL, Maher S, Sapin H, Poon JL, Boye K. Estimating meaningful change for The Impact of Weight on Self-Perception (IW-SP) questionnaire among people with type 2 diabetes. Qual Life Res. 2023 Jul 25. doi: 10.1007/s11136-023-03476-0. Epub ahead of print. PMID: 37491582.

Garvey WT, Frias JP, Jastreboff AM, le Roux CW, Sattar N, Aizenberg D, Mao H, Zhang S, Ahmad NN, Bunck MC, Benabbad I, Zhang XM; SURMOUNT-2 investigators. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 26:S0140-6736(23)01200-X. doi: 10.1016/S0140-6736(23)01200-X. Epub ahead of print. PMID: 37385275.

Boye, K.S., Thieu, V.T., Sapin, H. et al. Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. Diabetes Ther (2023). https://doi.org/10.1007/s13300-023-01451-z. ​https://link.springer.com/article/10.1007/s13300-023-01451-z#citeas

Toliver J, Watkins S, Byrne K, Oh J. PCR95 Functional Quality of Life Among People Living With Obesity: A Longitudinal Cohort of Patient Reported Outcomes. Value in Health. 2022;25:S408.​

Boye KS, Sapin H, Dong W, Williamson S, Lee CJ, Thieu VT. Improved Glycaemic and Weight Management Are Associated with Better Quality of Life in People with Type 2 Diabetes Treated with Tirzepatide. Diabetes Ther. 2023 Sep 5. doi: 10.1007/s13300-023-01457-7. Epub ahead of print. PMID: 37668888.

Poon, JL, Zhang, S, Kan, H, Bunck, MC, Dunn, J, Stefanski, A, Murphy, M. OR10-05 Improved Mental And Psychosocial Patient-Reported Outcomes Among People With Obesity Treated With Tirzepatide: Results From SURMOUNT-1 Study, Journal of the Endocrine Society, Volume 7, Issue Supplement_1, October-November 2023, bvad114.011, https://doi.org/10.1210/jendso/bvad114.011

​Wadden, T.A., Chao, A.M., Machineni, S. et al. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nat Med. 2023 Nov;29(11):2909-2918. doi: 10.1038/s41591-023-02597-w. Epub 2023 Oct 15. Erratum in: Nat Med. 2024 Jun;30(6):1784. doi: 10.1038/s41591-024-02883-1. PMID: 37840095; PMCID: PMC10667099.

Aronne LJ, Sattar N, Horn DB, et al. Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial. JAMA. 2024;331(1):38–48. doi:10.1001/jama.2023.24945

Mu Y, Bao X, Eliaschewitz FG, Hansen MR, Kim BT, Koroleva A, Ma RCW, Yang T, Zu N, Liu M; STEP 7 Study Group. Efficacy and safety of once weekly semaglutide 2·4 mg for weight management in a predominantly east Asian population with overweight or obesity (STEP 7): a double-blind, multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. 2024 Mar;12(3):184-195. doi: 10.1016/S2213-8587(23)00388-1. Epub 2024 Feb 5. PMID: 38330988.

Rubino D, Bjorner JB, Rathor N, Sharma AM, von Huth Smith L, Wharton S, Wadden T, Zeuthen N, Kolotkin RL. Effect of semaglutide 2.4 mg on physical functioning and weight- and health-related quality of life in adults with overweight or obesity: Patient-reported outcomes from the STEP 1-4 trials. Diabetes Obesity Metabolism. 2024 Jul;26(7):2945-2955. doi: 10.1111/dom.15620. Epub 2024 May 2. PMID: 38698650.

Zhao L, Cheng Z, Lu Y, Liu M, Chen H, Zhang M, Wang R, Yuan Y, Li X. Tirzepatide for Weight Reduction in Chinese Adults With Obesity: The SURMOUNT-CN Randomized Clinical Trial. JAMA. 2024 Aug 20;332(7):551-560. doi: 10.1001/jama.2024.9217. Erratum in: JAMA. 2024 Aug 20;332(7):595. doi: 10.1001/jama.2024.12249. PMID: 38819983; PMCID: PMC11337071.

Roza JM, Srivastava S. Effect of SophorOx® on Oxidative Stress and Body Composition in Individuals with High BMI: A Randomized Controlled Trial. Diabetes Metab Syndr Obes. 2024;17:2221-2234; https://doi.org/10.2147/DMSO.S452451

Hunter Gibble, T., Cao, D., Forrester, T.D., et al.; 1676-P: Tirzepatide Improved Mental and Psychosocial Function in Adults with Obesity or Overweight in the SURMOUNT-3 Trial. Diabetes 14 June 2024; 73 (Supplement 1): 1676–P. https://doi.org/10.2337/db24-1676-P
 
Hunter Gibble, T., Cao, D., Zhang, M.X., Xavier, N.A., Poon, J.L.; 1700-P: Weight Reduction Is Associated with Improved Quality of Life in Participants with Obesity or Overweight and Type 2 Diabetes—Results from Phase 3 SURMOUNT-2 Trial. Diabetes 14 June 2024; 73 (Supplement 1): 1700–P. https://doi.org/10.2337/db24-1700-P
 
Goetz, I.A., Sutter, C., Abraham, T.H., Kanu, C., Boye, K., Symonds, T.; 1695-P: The Evaluation of Clinical Outcomes Assessments and Digital Health Technologies in Obesity Clinical Trials. Diabetes 14 June 2024; 73 (Supplement 1): 1695–P. https://doi.org/10.2337/db24-1695-P

Sacher PM, Fulton E, Rogers V, Wilson J, Gramatica M, Dent JE, Aarts EO, Eccleston D, Greve JW, Palm-Meinders I, Chuttani R Impact of a Health Coach–Led, Text-Based Digital Behavior Change Intervention on Weight Loss and Psychological Well-Being in Patients Receiving a Procedureless Intragastric Balloon Program: Prospective Single-Arm Study. JMIR Form Res 2024;8:e54723. https://formative.jmir.org/2024/1/e54723/PDF

Gibble TM, Cao D, Murphy M, Jouravskaya I, Liao B. 5184 Tirzepatide Improved Mental and Psychosocial Health-Related Quality of Life in Adults with Obesity or Overweight: Results from the SURMOUNT-4 phase 3 Trial. J Endocr Soc. 2024 Oct 5;8(Suppl 1):bvae163.044. doi: 10.1210/jendso/bvae163.044. PMCID: PMC11453938.

Gibble TM, Cao D, Murphy M, Jouravskaya I, Liao B. 5183 Tirzepatide Improved Health-Related Quality of Life in People with Obesity or Overweight: Results from SURMOUNT-4 Phase 3 Trial, Journal of the Endocrine Society, Volume 8, Issue Supplement_1, October-November 2024, bvae163.042, https://doi.org/10.1210/jendso/bvae163.042