Abstract
BackgroundPhysiological and behavioral factors including hunger, satiety, food intake, and cravings are health determinants contributing to obesity. Patient-reported outcome (PRO) measures focused on eating-related factors provide insight into the relationships between food choice and quantity, weight change, and weight-loss treatment for individuals living with obesity. The DAILY EATS is a novel 5-item, patient-reported measure evaluating key eating-related factors (Worst and Average Hunger, Appetite, Cravings, and Satiety).MethodsPsychometric analyses, consistent with regulatory standards, were conducted to evaluate the DAILY EATS using data from two randomized trials that included individuals with severe obesity without diabetes (NCT03486392) and with severe obesity and type 2 diabetes (NCT03586830). Additional measures included Patient Global Impression of Status (PGIS) and Patient Global Impression of Change items, Impact of Weight on Quality of Life-Lite, Ease of Weight Management, and Patient-Reported Outcomes Measurement Information System Physical Function Short Form 8b and 10a. The reliability, validity, and responsiveness of the DAILY EATS were assessed, and a scoring algorithm and thresholds to interpret meaningful score changes were developed.ResultsItem-level analyses of the DAILY EATS supported computation of an Eating Drivers Index (EDI), comprising the related items Worst Hunger, Appetite, and Cravings. Internal consistency (Cronbach’s coefficient alphas ≥0.80) and test-retest reliability (coefficients > 0.7) of the EDI were robust. Construct validity correlation patterns with other PRO measures were as hypothesized, with moderate to strong significant correlations between the EDI and PGIS-Hunger (0.30 ≤ r ≤ 0.68), PGIS-Cravings (0.33 ≤ r ≤ 0.77) and PGIS-Appetite (0.52 ≤ r ≤ 0.77). Anchor- and distribution-based analyses support reductions ranging from 1.6 to 2.1 as responder thresholds for the EDI, representing meaningful within-person improvement.ConclusionsThe DAILY EATS individual items and the composite EDI are reliable, sensitive, and valid in evaluating the concepts of hunger, appetite, and cravings for use in individuals with severe obesity with or without type 2 diabetes.
Highlights
Physiological and behavioral factors including hunger, satiety, food intake, and cravings are health determinants contributing to obesity
A recent initiative to develop a patient-centered disease-illness model for obesity identified physiological and behavioral factors, including hunger, satiety, food intake, and cravings, as health determinants contributing to obesity [1]
For individuals living with obesity, with or without concomitant type 2 diabetes mellitus (T2DM), weight loss may relieve physical, social, emotional, and functional impacts associated with obesity [2, 3]
Summary
Physiological and behavioral factors including hunger, satiety, food intake, and cravings are health determinants contributing to obesity. Patient-reported outcome (PRO) measures focused on eating-related factors provide insight into the relationships between food choice and quantity, weight change, and weight-loss treatment for individuals living with obesity. A recent initiative to develop a patient-centered disease-illness model for obesity identified physiological and behavioral factors, including hunger, satiety, food intake, and cravings, as health determinants contributing to obesity [1]. Potential eating-related barriers to weight loss included difficulties in controlling hunger and appetite and the lack of the sensation of fullness after eating a meal. Individuals living with obesity may be able to lose weight or maintain a healthier weight if they have more control over these eating-related factors, allowing for more appropriate meal portion-sizes and fewer cravings, for foods high in calories. Patientreported outcome (PRO) measures focused on factors related to eating may help facilitate better understanding of the relationships between eating-related factors, weight change, and weight-loss treatment
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