NCT07206212

A Lifestyle Intervention to Reduce Cardiometabolic Risk Factors in Individuals With Obsessive-compulsive Disorder

Efficacy and Cost-effectiveness of a Lifestyle Intervention to Reduce Cardiometabolic Risk Factors in Individuals With Obsessive-compulsive Disorder: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall aim of this study is to evaluate the efficacy and cost-effectiveness of a lifestyle intervention to improve lifestyle habits and reduce cardiometabolic risk factors in individuals with obsessive-compulsive disorder (OCD).

Detailed description

Obsessive-compulsive disorder (OCD) is a prevalent and impairing disorder with an increased risk of morbidity and mortality due to cardiometabolic diseases. These risks remain significant over and above psychiatric comorbidities and shared familial factors, indicating that at least part of this risk could be a consequence of pernicious lifestyle habits (e.g., physical inactivity, unhealthy diet). A lifestyle intervention targeting cardiometabolic risk factors in people with OCD has previously been deemed feasible, acceptable, and safe. However, the efficacy and cost-effectiveness of the intervention need to be investigated. This will be the first RCT to examine the effects of a lifestyle intervention on the health and well-being of people with OCD. The specific aims are: 1. to investigate whether the intervention, compared to medical and lifestyle advice (control), is effective in increasing physical activity (objectively measured with an accelerometer); 2. to investigate the efficacy of the intervention, vs. the control, in changing cardiometabolic risk factors (lifestyle habits, cardiometabolic physiological, and laboratory measurements), mental health measures, functional impairment, and quality of life; and 3. to evaluate whether the lifestyle intervention, vs. the control, is cost-effective from a healthcare provider perspective.

Conditions

• Obsessive Compulsive Disorder (OCD)
• Lifestyle (Sedentary Behavior and Physical Activity)

Interventions

Type	Name	Description
BEHAVIORAL	A group-based lifestyle intervention for individuals with OCD	Participants will take part in 13 week program, with one individual session to set up goals for a change of lifestyle habits, based on the baseline evaluation of their clinical characteristics, lifestyle habits, and cardiometabolic risk, and 12 group sessions, consisting of both education on lifestyle habits and physical exercise. Each educational session will focus on a specific topic/lifestyle habit, alternating more informative sessions with sessions discussing how the information can be applied, taking into account specific hinders due to Obsessive-Compulsive Disorder. Between-sessions homework will include, for example, daily registration of physical activity and implementing changes in the lifestyle habits discussed during each session. All homework assignments will be registered in a digital platform. After the 13 weeks of lifestyle intervention, participants will get access to a booster module in the digital platform to help them maintain their behavioral changes.
BEHAVIORAL	Medical and lifestyle advice	One individual session with a clinical psychologist on week 1 of about 1 hour of duration. During this session, participants will receive feedback based on the baseline evaluation of their clinical characteristics, lifestyle habits, and cardiometabolic risk. Participants also receive written educational information on healthy lifestyle habits based on national Swedish guidelines issued by the National Board of Health and Welfare. The recommendations include engaging in regular physical activity, dietary guidelines based on Nordic Nutrition Recommendations, and advice to reduce alcohol consumption and quit tobacco use.

Timeline

• Start date: 2026-01-30
• Primary completion: 2027-11-01
• Completion: 2028-11-01
• First posted: 2025-10-03
• Last updated: 2026-02-02

Locations

1 site across 1 country: Sweden