Evaluation of a pilot for use of obesity medications outside hospital settings

 

Funding

National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research Ref NIHR162959.

Background

New anti-obesity medications such as Tirzepatide (Mounjaro) and Semaglutide (Wegovy) offer more effective obesity treatment when combined with behavioural interventions. These medications can be prescribed within specialist weight management services (SWMS), which lack nationwide availability and sufficient capacity for eligible individuals. NHS England (NHSE) is thus testing four new service models to access anti-obesity medication in primary care, necessitating a comprehensive evaluation to guide future implementation.

Aims

1) Evaluate the feasibility, acceptability, safety, effectiveness, and cost-effectiveness of new models for providing anti-obesity medication across socio-demographic groups,

2) Provide insights to guide future implementation of service models, promoting equitable access to anti-obesity medication.

Objectives

  1. Map key information across Integrated Care Boards (ICBs), including service model type(s) adopted and key features, socio-demographics, and stakeholders involved.
  2. Identify socio-demographic factors associated with rates of referral, uptake, and completion of service models for anti-obesity medication.
  3. Evaluate short-term clinical effectiveness, cost-effectiveness, and safety across models, considering socio-demographic differences.
  4. Model long-term health outcomes and costs for different service models.
  5. Explore potential cost-effectiveness of implementation initiatives to increase service uptake and adherence.
  6. Investigate feasibility and safety of new service models, considering staff needs, training, impact on primary care, and implications for the wider weight management tiered system.
  7. Assess acceptability and user experience of service models, including behavioural support components, across socio-demographic groups.
  8. Develop insights on the most acceptable, effective, safe, and cost-effective models for different sociodemographic groups, articulated through a preliminary logic model.
  9. Identify primary care training needs and resources for future rollout.
  10. Identify key criteria for a full evaluation of further phases of the rollout of anti-obesity medication.

Methods, timelines and anticipated impact and dissemination

The project will run from February 2025 to January 2028. It employs mixed methods across five work packages (WPs):

WP1 (Months 1-36, objective 1): Project management, PPIE, stakeholder engagement, and mapping key information about ICB service models to support subsequent WPs.

WP2 (Months 6-33, objectives 2-5): Identify socio-demographic factors associated with service utilization. Evaluate clinical and cost-effectiveness and safety across models and socio-demographic groups using a target trial framework. Data collection includes electronic health records and surveys with people living with obesity (PLWO), service providers, and commissioners.

WP3 (Months 6-30, objectives 6,7): Employ qualitative methods at four case study sites (representing each service model) to assess feasibility, acceptability, safety, and behaviour change factors in different socio-demographic groups. Supported by a ‘researcher in residence’ model and PPIE community researchers.

WP4 (Months 6-36, objective 8): Integrate data across WPs 2&3 with mixed methods analysis. Use a triangulation protocol with key stakeholders to inform a logic model mapping service commissioning and setup to patient outcomes.

WP5 (Months 1-36, objectives 9,10): Dissemination, outputs, and anticipated impact. Inform NHSE to guide further phases of the roll-out and future evaluation, emphasizing access across socio-demographic groups.

Who is leading the research?

Dr Karen Coulman, Associate Professor in Obesity Research and Practice, Bristol Medical School (PHS), University of Bristol.

Further information

CI Email: Karen.Coulman@bristol.ac.uk

For more information or to get involved in this project, please contact bnssg.research@nhs.net.

The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care

Please find more information here.