Development and validation of an eating behavior patient-reported outcome measure in people living with obesity or overweight.

Abstract

The objective of this study was to develop a measure of eating behaviors in adults living with obesity or overweight. Based on concept-elicitation (n = 53) and cognitive-debriefing (n = 15) studies, a draft eating behavior patient-reported outcome (EB PRO) measure was developed. Its psychometric properties were established using data from a 46-week clinical trial of an investigational antiobesity medication (n = 387). The final EB PRO comprised 12 items across two domains (i.e., "Desire to Eat" and "Capacity to Resist"; 6 items each) and a Total Eating Behavior score (0-48; higher scores worse). The EB PRO demonstrated good test-retest reliability (intraclass correlation coefficients > 0.7). Confirmatory factor analysis showed a comparative fit index of 0.98 with good internal consistency (Cronbach α > 0.7). The EB PRO generally exhibited moderate-to-large correlations with the Patient Global Impression of Severity questionnaire and Three-Factor Eating Questionnaire and weaker correlation with the 36-Item Short-Form Health Survey version 2 Physical Functioning scale. All EB PRO scores improved from baseline to week 46 (p < 0.0001), demonstrating sensitivity to change with therapy. Clinically meaningful thresholds were defined as eight- and four-point changes in Total Eating Behavior and domain scores, respectively. The EB PRO measure is a promising tool for assessing eating behaviors in people with obesity or overweight.