# The evaluation of clinical outcomes assessments and digital health technologies in clinical trials for obesity

## TL;DR

This paper reviews how clinical trials for obesity use patient-reported outcomes and digital health tools to assess the impact of weight loss on quality of life and physical function.

## Contribution

The study provides a comprehensive analysis of COAs and DHTs used in obesity trials, highlighting gaps in DHT adoption and common PRO measures.

## Key findings

- PRO measures like the Short Form 36 were most commonly used in obesity trials.
- Physical function was the most frequently assessed domain in secondary endpoints.
- Digital health technologies were rarely used compared to traditional COAs.

## Abstract

Clinical trials for obesity have traditionally focused on weight loss and resolution of comorbidities as primary outcomes. However, secondary outcomes, such as the impact of weight reduction on patient experience, like health-related quality of life (HRQoL), have increasingly been recognized as important. Therefore, a review was conducted to determine the Clinical Outcome Assessments (COAs) and Digital Health Technologies (DHTs) used in clinical trials for obesity to assess the patient experience.

Two clinical trial databases (United States & European Union) were reviewed to identify Phase 2–4 clinical trials for obesity (2018–2023). A targeted literature review was also conducted using the OVID database to identify clinical trial for obesity publications which included COAs/DHTs (2010–2023).

Trials from the databases (n = 53) and publications (n = 42) were included in data extraction (N = 73). This resulted in identification of 108 COAs, the majority being patient-reported outcome (PRO) measures (n = 83), but also 24 performance outcomes (PerfO) measures, and 1 composite PRO-clinician-reported outcomes (ClinRO) measure, as well as 2 DHTs. The most frequently identified PRO measures were the Short Form 36 and the Impact of Weight on Quality of Life Lite Clinical Trials. Twenty-four PerfO measures were also identified, with the 6-minute walk test being most common. These measures were most often used to construct secondary endpoints, with physical function (PF) being the most frequently specified domain. PRO measures assessing eating-related thoughts/behaviours, physical activity, and disordered eating were also frequently included, although individual measures varied widely across trials.

Review of COAs and DHTs in registered clinical trials and publications for obesity found that PRO measures were the most common type of COA used to develop endpoints with current use of DHTs limited. Specifically, the physical function domain of multidimensional patient-reported outcome measures assessing health-related quality of life were often used to construct secondary endpoints. Further work is warranted to assess how the COAs and DHT data collected in clinical trials are viewed by regulators and payers.

The online version contains supplementary material available at 10.1186/s41687-025-00841-0.