The IWQOL-Lite Clinical Trials Version© (IWQOL-Lite-CT©) was developed for use in the context of clinical trials for obesity, addressing concerns that are specifically relevant to these participants. The 20 items in this instrument cover the full range of concerns in this population (i.e., has content validity) and the items are easily understood and consistently reported as salient and likely to change with 10% weight loss. The IWQOL-Lite-CT© has the potential to support labeling claims, as it was developed and validated in accordance with the Food and Drug Administration’s “Guidance for industry; Patient-reported outcome measures: use in medical product development to support labeling claims, December 2009.”
Interest in the IWQOL-Lite-CT© has been expressed not only for obesity research, but also for other diseases and treatments that affect weight, such as diabetes and severe mental illness.
Publications for the IWQOL-Lite-CT© include:
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.
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.
To date, a total of 43 harmonized translations of the IWQOL-Lite-CT© have been developed in accordance with industry standards.
Licensing for IWQOL-Lite-CT is managed solely through Pattern Health, a passionate team of technologists, clinicians and behavioral researchers whose vision is to make healthcare more efficient and effective by creating products that empower patient self-care and research.
The new digital versions, which can be used standalone or integrated into digital care plans and clinical trials, will be more accessible and engaging for patients while improving the accuracy and reliability of the collected data.
Click the button below to engage Pattern Health with questions or licensing information.
Do You Have Questions?
If you have any further questions, please contact me.