A Lifestyle Intervention to Reduce Cardiometabolic Risk Factors in Individuals With Obsessive-compulsive Disorder
LIFT
Efficacy and Cost-effectiveness of a Lifestyle Intervention to Reduce Cardiometabolic Risk Factors in Individuals With Obsessive-compulsive Disorder: A Randomized Controlled Trial
6 other identifiers
interventional
108
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2025
CompletedFirst Posted
Study publicly available on registry
October 3, 2025
CompletedStudy Start
First participant enrolled
January 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
February 2, 2026
January 1, 2026
1.8 years
September 11, 2025
January 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical activity: Steps per day
Measured as change in steps/day with an accelerometer. Participants will be asked to wear an accelerometer (activPAL™) 24 hours/day for seven consecutive days at each assessment point. The device is placed on the thigh. Data will be considered valid if wear time is ≥10 hours/day for at least 4 days, including at least one weekend day.
Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.
Secondary Outcomes (37)
Physical activity: Moderate to vigorous physical activity (MVPA)
Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.
International Physical Activity Questionnaire, short form (IPAQ-SF)
Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.
15-item Food Frequency Questionnaire (FFQ)
Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.
Alcohol Use Disorder Identification Test for Consumption (AUDIT-C)
Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.
Tobacco use
Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.
- +32 more secondary outcomes
Other Outcomes (2)
Adverse events
Week 7 after the start of the intervention, week 14 after the start of the intervention (primary endpoint).
Concurrent interventions
Baseline, week 7 after the start of the intervention, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.
Study Arms (2)
Active intervention
EXPERIMENTALThe lifestyle intervention (LIFT) consists of one initial individual session to create a personal plan and set up goals for a change of lifestyle habits (week 1) and 12 weekly group sessions (weeks 2 to 13) including both education on lifestyle habits and physical exercise. After week 13, participants get access to a booster module in a digital platform to help them maintain their behavioral changes.
Medical and lifestyle advice
ACTIVE COMPARATORParticipants in this arm will receive one individual session where participants will receive feedback based on the baseline evaluation of their clinical characteristics, lifestyle habits, and cardiometabolic risk (week 1). Additionally, participants will receive written educational information on healthy lifestyle habits.
Interventions
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.
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.
Eligibility Criteria
You may not qualify if:
- Inability to understand and communicate in Swedish. Confirmed by the assessor at the initial phone call.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Stockholmcollaborator
- Karolinska Institutetlead
Study Sites (1)
OCD-Programmet, Psykiatri Sydväst
Huddinge, Stockholm County, 141 57, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lorena Fernández de la Cruz, PhD
Karolinska Institutet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 11, 2025
First Posted
October 3, 2025
Study Start
January 30, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2028
Last Updated
February 2, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
The investigators may potentially share trial data from the study with other researchers around the world. The use would primarily be to combine outcome data for potential meta-analyses in this research field. Shared data will be pseudonymised. The possibility of future data sharing is mentioned in the informed consent form.