Validation of a new measure of quality of life in obesity trials: Impact of Weight on Quality of Life-Lite Clinical Trials Version

Ronette L Kolotkin, Valerie S L Williams, Claire M Ervin, Nicole Williams, Henrik H Meincke, Shanshan Qin, Lisa von Huth Smith, Sheri E Fehnel, Ronette L Kolotkin, Valerie S L Williams, Claire M Ervin, Nicole Williams, Henrik H Meincke, Shanshan Qin, Lisa von Huth Smith, Sheri E Fehnel

Abstract

The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) is widely used in evaluations of weight-loss interventions, including pharmaceutical trials. Because this measure was developed using input from individuals undergoing intensive residential treatment, the IWQOL-Lite may include concepts not relevant to clinical trial populations and may be missing concepts that are relevant to these populations. An alternative version, the IWQOL-Lite Clinical Trials Version (IWQOL-Lite-CT), was developed and validated according to the US Food and Drug Administration's (FDA's) guidance on patient-reported outcomes. Psychometric analyses were conducted to validate the IWQOL-Lite-CT using data from two randomized trials (NCT02453711 and NCT02906930) that included individuals with overweight/obesity, with and without type 2 diabetes. Additional measures included the SF-36, global items, weight and body mass index. The IWQOL-Lite-CT is a 20-item measure with two primary domains (Physical [seven items] and Psychosocial [13 items]). A five-item Physical Function composite and Total score were also supported. Cronbach's alpha and intraclass correlation coefficients exceeded 0.77 at each time point; patterns of construct validity correlations were consistent with hypotheses; and scores demonstrated treatment benefit. The IWQOL-Lite-CT is appropriate for assessing weight-related physical and psychosocial functioning in populations commonly targeted for obesity clinical trials. Qualification from the FDA is being sought for use of the IWQOL-Lite-CT in clinical trials to support product approval and labelling claims.

Keywords: Impact of Weight on Quality of Life-Lite (IWQOL-Lite); Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT); health-related quality of life; patient functioning; psychometric validation.

Conflict of interest statement

This study was conducted under a research contract between Novo Nordisk and RTI Health Solutions and was funded by Novo Nordisk. R.L.K. is a consultant for Novo Nordisk and RTI Health Solutions. V.S.L.W., C.M.E., N.W., S.Q. and S.E.F. are salaried employees of RTI Health Solutions. H.H.M. and L.H.S. are salaried employees of Novo Nordisk.

© 2019 Novo Nordisk A/S. Clinical Obesity published by John Wiley & Sons Ltd on behalf of World Obesity Federation.

Figures

Figure 1
Figure 1
Impact of Weight on Quality of Life‐Lite‐Clinical Trials Version structure. The Physical Function composite includes the items in bold. Abbreviation: IWQOL‐Lite‐CT, Impact of Weight on Quality of Life‐Lite Clinical Trials Version

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