A lifestyle intervention to reduce cardiometabolic risk factors in individuals with obsessive-compulsive disorder
| ISRCTN | ISRCTN57160973 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57160973 |
| ClinicalTrials.gov (NCT) | NCT07206212 |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2025-04734-01 |
| Sponsor | Psychiatry Southwest [Psykiatri Sydväst], Stockholm Healthcare Services [Stockholms läns sjukvårdsområde (SLSO)], Region Stockholm |
| Funders | Hjärt-Lungfonden (Swedish Heart and Lung Foundation), Vetenskapsrådet, Forskningsrådet för hälsa, arbetsliv och välfärd, Region Stockholm, Karolinska Institutet, Kricastiftelsen (Krica Foundation) |
- Submission date
- 27/10/2025
- Registration date
- 06/11/2025
- Last edited
- 06/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Obsessive-compulsive disorder (OCD ) is characterized by intrusive thoughts and compulsive behaviors or rituals. OCD is time-consuming, often causes great suffering, and affects day-to-day functioning, often affecting work or studies and social relationships. Previous research has shown that, compared to the general population, people with OCD are at increased risk of developing cardiometabolic disorders, such as cardiovascular disease and type 2 diabetes. Many of those diseases can largely be prevented by changing one's lifestyle habits (e.g., increasing physical activity, eating heatlhier, and avoiding alcohol and smoking).
This study aims to compare a comprehensive lifestyle intervention in a group format, including educational and exercise sessions, to medical and lifestyle advice.
Who can participate?
Participants will be people aged 18 years and older who meet criteria for OCD (assessed by a psychologist at initial conversations) and have a sedentary lifestyle (they have less than 150 minutes/week of moderate or high intensity physical activity - i.e. physical activity that makes you feel a bit warm and short of breath).
What does the study involve?
Potential participants will first be asked to complete some introductory questions online to ensure that the study is suitable for them. After that, they may be contacted for a telephone interview to get more information about the study and check if they meet criteria for participation. If so, they will be booked in for an interview with a psychologist to go through questions about their mental well-being. This visit will take 1-1.5 hours. They will also undergo a health check with a nurse where blood tests, blood pressure, weight, waist circumference, and other health-related measures will be collected. Potential participants will also be asked whether they have had any previous health problems or are taking any medication. This visit is estimated to take about 1 hour. After this visit, potential participants will also be given an activity tracker, known as an accelerometer, that they will wear on their thigh for a week to measure physical activity. Participants will also be asked to fill out a number of questionnaires. Those meeting all the eligibility criteria will be included in the study.
To be able to measure the effect of the intervention that we want to test, participants will be randomly assigned to one of two different groups. One group will undergo a structured lifestyle intervention for 13 weeks, which includes an initial meeting to set individual goals and 12 group meetings (2 hours per session) consiting of lectures providing information on how lifestyle habits can be changed and physical exercise. The other group will get one individual session where they will receive feedback based on the baseline evaluation of their clinical characteristics, lifestyle habits, and cardiometabolic risks, as well as written educational information on healthy lifestyle habits based on national Swedish guidelines issued by the National Board of Health and Welfare.
For those included, the above outlined assessments will be repeated after the intervention, and 3, 6, and 12 months after the end of the intervention.
What are the possible benefits and risks of participating?
Making changes to the lifestyle can be tough, and it is possible that anxiety and OCD symptoms may temporarily increase. Increasing one's physical activity can be tiring and can also cause temporary aches and fatigue. Previous research using similar lifestyle programs has shown that participating in these kind of interventions is safe. Additionally, by participating in the study, participants will have the chance to improve their lifestyle habits which, in turn may contribute to improve physical health and prevent a number of somatic conditions. Moreover, participants will also be contributing to the scientific research on OCD, lifestyle habits, and physical health, which can influence how the healthcare system is organized in the future.
Where is the study run from?
The study includes one single site, which is the adult specialist clinic OCD-programmet, at Psychiatry Southwest, Karolinska University Hospital [Karolinska Universitetssjukhuset] in Stockholm. Study screenings, inclusion and follow-up assessments, and the delivery of the intervention will take place at this site. The organizations responsible for the study project are the healthcare services at Region Stockholm (SLSO) and Karolinska Institutet.
When is the study starting and how long is it expected to run for?
The study will start recruiting in November 2025. Participants in the trial will be active in the study for about 15 months (including the intervention plus one year of follow-up). We anticipate that the recruitment will take about 2 years. In total, the duration of the trial (from enrolment of first participant to last participant’s final measurement point) will be about 39 months.
Who is funding the study?
This trial is funded by several Swedish funding bodies, including Hjärt-Lungfonden (Swedish Heart and Lung Foundation; grant numbers: 20220899 and 20210493); Vetenskapsrådet (Swedish Research Council; grant number: 2022-005109); FORTE: Forskningsrådet för hälsa, arbetsliv och välfärd (Swedish Research Council for Health, Working Life and Welfare; grant number: 2019-00438), Region Stockholm/ALF Medicin project grant (grant number: 20200139), Karolinska Institutet (grant numbers: 2020-01361 and 2022-01675), and Kricastiftelsen (Krica Foundation).
Who is the main contact?
Study coordinators Sofia Asplund and Anna Holmberg can be contacted via email or phone for questions relating to the study (sofia.asplund@ki.se or anna.holmberg.2@ki.se, phone: 08-123 391 05). The principal investigator is Lorena Fernández de la Cruz (lorena.fernandez.de.la.cruz@ki.se).
Contact information
Scientific, Principal investigator
Centre for Psychiatry Research
Department of Clinical Neuroscience, Karolinska Institutet
Gävlegatan 22B, Floor 8
Stockholm
11330
Sweden
 ORCID ID |
0000-0002-1571-5485 |
|---|---|
| Phone | +46 (0)768477999 |
| lorena.fernandez.de.la.cruz@ki.se |
Public, Scientific
Centre for Psychiatry Research
Department of Clinical Neuroscience, Karolinska Institutet
Gävlegatan 22B, Floor 8
Stockholm
11330
Sweden
| ORCID ID |
0009-0002-9548-7263 |
|---|---|
| Phone | +46 (0)812339105 |
| anna.holmberg.2@ki.se |
Public, Scientific
Centre for Psychiatry Research
Department of Clinical Neuroscience, Karolinska Institutet
Gävlegatan 22B, Floor 8
Stockholm
11330
Sweden
| ORCID ID |
0000-0003-2666-5329 |
|---|---|
| Phone | +46 (0)812339105 |
| sofia.asplund@ki.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Superiority parallel-group randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Efficacy and cost-effectiveness of a lifestyle intervention to reduce cardiometabolic risk factors in individuals with obsessive-compulsive disorder: A randomized controlled trial |
| Study acronym | LIFT |
| Study objectives | 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). The specific aims are: 1. To investigate whether the lifestyle intervention (LIFT, active 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 3. To evaluate whether the lifestyle intervention, vs the control, is cost-effective from a healthcare provider perspective |
| Ethics approval(s) |
Approved 27/08/2025, Swedish Ethical Review Authority (Box 2110, Uppsala, 75002, Sweden; +46 (0)104750800; registrator@etilprovning.se), ref: 2025-04734-01 |
| Health condition(s) or problem(s) studied | Reduction of cardiometabolic risk factors and improvement of lifestyle habits in individuals with obsessive-compulsive disorder |
| Intervention | The included participants will be randomized at a 1:1 ratio to the active intervention or the control condition using randomly varying block sizes. Randomization will be conducted using an online randomization service (TENALEA), set up and monitored by a third party, the Karolinska Trial Alliance. The randomization will be implemented consecutively in TENALEA, which requires an authorized trial coordinator to provide a participant ID to generate a unique allocation certificate with participant ID, allocation, personnel ID, and time stamp. One or several researchers (according to a task delegation list) will be responsible for the enrolment of participants, randomization, and assigning participants to the groups. Participants will be informed that they will be allocated to LIFT or to a control. Assessors will be blind to the allocation group, and, at each follow-up assessment, they will remind the participants not to reveal details about their allocation. ACTIVE INTERVENTION: LIFESTYLE INTERVENTION (LIFT): The lifestyle intervention consists of two components: one initial individual session and 12 weekly group sessions including both education on lifestyle habits and physical exercise. At week 1, participants will be offered one individual session with a clinical psychologist to create a personal plan and set up goals for a change of lifestyle habits, based on the baseline evaluation of their clinical characteristics, lifestyle habits, and cardiometabolic risk. This session will be conducted via video or face-to-face at Karolinska Hospital, Huddinge and will have a duration of about 1 hour. From week 2 to week 13, the participants will take part in 12 weekly group sessions, consisting of both education on lifestyle habits and physical exercise. Participants will receive a phone call the morning of the day of the session to assess risk and the possibility to attend and participate in the session. The groups will be conducted at OCD-programmet, Karolinska Hospital, Huddinge and will be facilitated by two psychologists with experience working with OCD. The total time for these sessions will be 1.5 to 2 hours every week, including a short break. The education part is based on a previous lifestyle intervention evaluated for patients with cardiovascular risk without known psychiatric conditions, which was adapted for individuals with OCD and tested in our previous pilot trial (PMID: 40746134). Further adaptations have been made based on the experiences of the pilot, including results and participants’ feedback. 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 OCD. The sessions are designed to actively engage participants and encourage group discussions. Cognitive-behavior therapy strategies to achieve behavioral change are incorporated throughout the intervention, such as psychoeducation, self-monitoring, goal setting, problem-solving, and maintenance of changes. The educational part will last around 1 hour each session. The physical activity part is based on the Braining project (https://www.psykiatrisydvast.se/vard-hos-oss/oppenvard/affektiva--och-angestprogrammet/braining/). Braining consists of group exercise sessions led by mental health staff at Psychiatry Southwest, Region Stockholm. The sessions focus on aerobic exercise of medium to vigorous intensity and also include body weight strength-training exercise. Each session lasts 30 to 45 minutes. Besides taking part in the weekly exercise session exclusively for the study group, participants will have the opportunity and will be encouraged to attend more Braining sessions (already ongoing at the hospital for other patients with a range of mental disorders) in order to increase the weekly time dedicated to moderately intense physical activity. 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 the digital platform BASS. After the 13 weeks of lifestyle intervention, participants will get access to a booster module in the digital platform BASS to help them maintain their behavioral changes. In this booster module, participants will be encouraged to continue to set up goals and promote changes in their lifestyle and review their progress. Further, information about common hinders to maintain changes and problem-solving strategies will be presented in this module. Online therapist support will be offered during the 3 months following the end of the intervention, but the booster module will continue to be available until the 12-month follow-up as a self-guided support tool. CONTROL INTERVENTION: MEDICAL AND LIFESTYLE ADVICE: Participants allocated to this arm will receive one individual session with a clinical psychologist on week 1, directly after randomization and allocation to this arm. This session will be conducted via video or face-to-face at Karolinska Hospital, Huddinge and will have a duration of about 1 hour. During this session, participants will receive feedback based on the baseline evaluation of their clinical characteristics, lifestyle habits, and cardiometabolic risk. Additionally, they will 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. At week 6, participants will be contacted on the phone for a brief individual follow-up. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Physical activity, measured as change in steps/day with an accelerometer at post-intervention. 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. |
| Key secondary outcome measure(s) |
All secondary outcome measures will be collected at post-intervention (primary endpoint) and 3, 6, and 12 months after the primary endpoint, unless otherwise specified. |
| Completion date | 01/02/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 108 |
| Key inclusion criteria | 1. Meeting criteria for OCD, based on the diagnostic criteria of the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders. 2. Physical inactivity/sedentarism, operationalized as less than 150 minutes of physical activity per week during the last month, evaluated by asking two questions from the National Board of Health and Welfare concerning: a) frequency of weekly moderate or vigorous intensity physical exercise, and b) frequency of weekly non-exercise/daily life physical activity. 3. Aged 18 years or older. |
| Key exclusion criteria | 1. Intellectual disability or severe psychiatric symptoms or suicidal risk that could interfere with the intervention 2. A diagnosis of an eating disorder or a substance use disorder 3. Being pregnant or <1 year postpartum 4. Myocardial infarction or stroke within the last 6 months 5. Cardiovascular risk measures significantly over the normal range (e.g., severe hypertension [blood pressure above ≥180 mmHg systolic or ≥110 mmHg diastolic]) or a current somatic condition that make participation in the intervention contraindicated 6. Initiation or adjustment of any cardiometabolic medication (e.g., blood pressure or blood lipids lowering mediation) within 3 months prior to assessments 7. Inability to understand and communicate in Swedish 8. Inability to consistently attend the sessions involved in the intervention 9. Inability to travel to the sessions involved in the intervention |
| Date of first enrolment | 01/11/2025 |
| Date of final enrolment | 01/11/2027 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Stockholm
141 86
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | We 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/10/2025: Study's existence confirmed by the Swedish Ethical Review Authority.
