Development of the Eating Drivers Diary (EDDY): A Novel Patient-Reported Outcome Measure for Use in Clinical Trials of Medications for Weight Reduction
Author(s)
Claire Ervin, MPH1, Lindsey Norcross, MA1, Anne Flint, PhD2, Arne Heydorn3, Michael Lowe, PhD4, Joseph Nadglowski, BS5, Lisa von Huth Smith, MSc, PhD6, Sheri Fehnel, PhD1.
1RTI Health Solutions, Research Triangle Park, NC, USA, 2Novo Nordisk, Søborg, Denmark, 3Denmark, 4Drexel University, Philadelphia, PA, USA, 5Obesity Action Coalition, Tampa, FL, USA, 6Novo Nordisk, Bagsværd, Denmark.
1RTI Health Solutions, Research Triangle Park, NC, USA, 2Novo Nordisk, Søborg, Denmark, 3Denmark, 4Drexel University, Philadelphia, PA, USA, 5Obesity Action Coalition, Tampa, FL, USA, 6Novo Nordisk, Bagsværd, Denmark.
OBJECTIVES: Internal eating-related factors (e.g., hunger, satiety, control of food intake, cravings) may contribute to overweight and obesity. This study aimed to develop, in accordance with United States (US) Food and Drug Administration (FDA) methodological requirements, a patient-reported outcome (PRO) measure to evaluate internal eating-related drivers for use in clinical trials of medications for weight reduction.
METHODS: Concepts for potential inclusion in the Eating Drivers Diary (EDDY) were identified through a literature review, consultation with 3 experts in the field of obesity, and concept elicitation interviews with 16 adults with overweight or obesity. An initial pool of items (concepts) was drafted to address internal drivers that participants identified as important to modify with pharmacotherapy, each referencing a 24-hour recall period. The item pool was then evaluated and refined across 3 iterative rounds of cognitive debriefing interviews with a total of 24 adults with overweight or obesity.
RESULTS: The following concepts were consistently identified in the literature, by obesity experts, and by interview participants as salient to individuals with overweight or obesity: hunger, appetite, satiety, cravings, and control of eating. The initial item pool addressed these concepts using different question wordings and response scales. Appetite was deemed largely redundant with hunger and a less specific concept. The concept of satiety was most clearly and consistently understood in items addressing fullness. Thus, the final version of the measure includes 6 items evaluating aspects of hunger, fullness, cravings, and control of eating. Interview participants deemed the final version of the EDDY to be comprehensive, including each of the central internal eating-related drivers influencing weight reduction, and the final items to be clear and easy to answer.
CONCLUSIONS: Results of this qualitative study provide strong support for the content validity of the 6-item EDDY. A rigorous psychometric evaluation using data from 3 clinical trials is planned.
METHODS: Concepts for potential inclusion in the Eating Drivers Diary (EDDY) were identified through a literature review, consultation with 3 experts in the field of obesity, and concept elicitation interviews with 16 adults with overweight or obesity. An initial pool of items (concepts) was drafted to address internal drivers that participants identified as important to modify with pharmacotherapy, each referencing a 24-hour recall period. The item pool was then evaluated and refined across 3 iterative rounds of cognitive debriefing interviews with a total of 24 adults with overweight or obesity.
RESULTS: The following concepts were consistently identified in the literature, by obesity experts, and by interview participants as salient to individuals with overweight or obesity: hunger, appetite, satiety, cravings, and control of eating. The initial item pool addressed these concepts using different question wordings and response scales. Appetite was deemed largely redundant with hunger and a less specific concept. The concept of satiety was most clearly and consistently understood in items addressing fullness. Thus, the final version of the measure includes 6 items evaluating aspects of hunger, fullness, cravings, and control of eating. Interview participants deemed the final version of the EDDY to be comprehensive, including each of the central internal eating-related drivers influencing weight reduction, and the final items to be clear and easy to answer.
CONCLUSIONS: Results of this qualitative study provide strong support for the content validity of the 6-item EDDY. A rigorous psychometric evaluation using data from 3 clinical trials is planned.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PT15
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity)