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

N/ARecruitingNCT07206212

Karolinska Institutet108 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

108

Conditions

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

Interventions

A group-based lifestyle intervention for individuals with OCDBEHAVIORAL

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.

Medical and lifestyle adviceBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. A diagnosis of obsessive-compulsive disorder (OCD), based on the diagnostic criteria of the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders. Screened at registration and at the initial phone call and confirmed by the assessor at the inclusion assessment (psychiatric interview), using a semi-structured diagnostic interview. 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 Swedish National Board of Health and Welfare concerning 1) frequency of weekly moderate or vigorous intensity physical exercise and 2) frequency of weekly non-exercise/daily life physical activity. Screened at registration and at the initial phone call and confirmed by the assessor at the inclusion assessment (psychiatric interview). 3. Aged 18 years or older. Screened at registration and confirmed by the assessor at the initial phone call and/or confirmed by the assessor at the inclusion assessment (psychiatric interview). Exclusion criteria: 1. Intellectual disability or severe psychiatric symptoms or suicidal risk that could interfere with the intervention. Screened at the initial phone call and confirmed by the assessor at the inclusion assessment (psychiatric interview), using a semi-structured diagnostic interview. 2. A diagnosis of an eating disorder or a substance use disorder. Screened at the initial phone call and confirmed by the assessor at the inclusion assessment (psychiatric interview), using a semi-structured diagnostic interview. 3. Being pregnant or \<1 year postpartum. Screened at the initial phone call and confirmed by the assessor at the inclusion assessment (psychiatric interview). 4. Myocardial infarction or stroke within the last 6 months. Screened at registration and confirmed by the assessor at the initial phone call and/or the inclusion assessment (physiological measures). 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. Screened at registration and confirmed by the assessor at the initial phone call and/or the inclusion assessment (physiological measures), after consulting with the study doctor, if necessary. 6. Initiation or adjustment of any cardiometabolic medication (e.g., blood pressure or blood lipids lowering mediation) within 3 months prior to assessments. Screened at registration and confirmed by the assessor at the initial phone call and/or the inclusion assessment (physiological measures). 7. Inability to understand and communicate in Swedish. Confirmed by the assessor at the initial phone call. 8. Inability to consistently attend the sessions involved in the intervention. Screened by the assessor at the initial phone call and/or confirmed by the assessor at the inclusion assessment (psychiatric interview). 9. Inability to travel to the sessions involved in the intervention. Screened by the assessor at the initial phone call and/or confirmed by the assessor at the inclusion assessment (psychiatric interview).

Locations (1)

OCD-Programmet, Psykiatri Sydväst

Huddinge, Stockholm County, Sweden

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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

Physical activity: Moderate to vigorous physical activity (MVPA)

MVPA per day operationalised as a walking cadence of \>100 steps/minute.

Time frame: 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)

Self-reported assessment of physical activity (moderately intense activities, vigorously intense activities, walking) and sedentary time during the last 7 days. Responses on each physical activity intensity question will be converted to metabolic equivalent of task (MET) minutes, using the formula from the IPAQ scoring protocol. Both the continuous and categorical scores (high, moderate, and low) will be calculated according to the scoring guidelines. A higher MET score corresponds to higher levels of physical activity.

Time frame: 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)

Self-reported assessment of dietary patterns. It consists of 15 items concerning dietary choices, where each item is evaluated as either meeting or not meeting the guidelines set in the Nordic Nutrition Recommendations (NNR). Each met recommendation receives 1 point, resulting in a healthy eating index ranging from 0 to 15 points. Based on this index, dietary patterns are classified as good (9 or more points), average (6-8 points) or poor (5 or fewer points).

Central Contacts

Sofia Asplund, MSc

CONTACT

0046706965597 sofia.asplund@ki.se

Anna Holmberg, MSc

CONTACT

0046739741584 anna.holmberg.2@ki.se

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 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)

Self-reported assessment of alcohol consumption. Scores in the AUDIT-C range from 0 to 12 points, where 0 points indicate no alcohol use. Cut-off scores for risk consumption vary across settings and population, but a score ≥4 points has been suggested as a cut-off for detecting risk consumption of alcohol when validated in the general population.

Time frame: 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

Evaluated by asking self-reported questions about current or previous use of cigarettes, snus or other tobacco or nicotine products. If current use, or if they quit during the last 6 months, participants are asked to specify frequency (daily, sometimes) and amount used.

Time frame: 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.

Perceived Stress Scale (PSS)

Self-reported assessment of perceived stress. The total score ranges from 0 to 40, with higher scores indicating higher levels of perceived stress.

Time frame: 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.

Insomnia Severity Scale (ISI)

Self-reported assessment of sleep problems and severity of symptoms. Consists of 7 items that are rated on a 5-point Likert scale to evaluate sleep problems and severity of symptoms. The total score ranges from 0 to 28 points, with a higher score indicating more severe sleep problems.

Time frame: 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.

Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

Clinician-rated semi-structured interview to assess OCD symptom severity. The Y-BOCS consists of 10 items rated from 0 to 4, with a total score from 0 to 40, where a higher score corresponds to more severe OCD.

Time frame: 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.

Obsessive-Compulsive Inventory - 12 (OCI-12)

Self-reported assessment of OCD symptoms. Consists of 12 items rated on a 5-point Likert scale, with total scores ranging from 0-48. Scores between 0 and 12 indicate mild, between 13 and 21 indicate moderate, and between 22 and 48 indicate severe OCD symptoms.

Time frame: 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.

Patient Health Questionnaire (PHQ-9)

Self-reported assessment of symptoms of depression. In this 9-item scale the total score ranges from 0 to 27 points, with a higher score corresponding to more severe symptoms of depression.

Time frame: 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.

EuroQol five dimensional five level questionnaire (EQ-5D-5L)

Self-rated assessment of own health status in five dimensions (mobility; self-care; usual activities; pain/discomfort; and anxiety/depression), within five levels of severity (no problems; slight problems; moderate problems; severe problems; or extreme problems). The scale also comprises a rating of their overall health status on a scale from 0-100 (0 = worst imaginable health; 100 = best imaginable health), the EQ-VAS scale. The scores are combined to calculate a health utility number, with the health utilities ranging from -0.31 for the worst to 1 for the best EQ-5D-5L states in Sweden.

Time frame: 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.

Work and Social Adjustment Scale (WSAS)

Self-reported assessment of impairment in functioning, in terms of work, home management, social leisure activities, private leisure activities, and relationships. Each item is rated on a scale from 0 to 8, with the total score ranging from 0 to 40. A higher score corresponds to more impairment in functioning.

Time frame: 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.

Waist circumference

Measured in a standing position, midway between the lower rib margin and the iliac crest, in centimeters (cm) at the nearest 0.5 cm.

Time frame: 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.

Sagittal abdominal diameter

Measured in a supine position at the nearest 0.1 centimeter with a ruler and a water lever or a caliper, at the level of the umbilical.

Time frame: 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.

Weight

Measured in kilograms, to the nearest 0.1 kg.

Time frame: 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.

Body Mass Index (BMI)

Derived by dividing weight (in kilograms measured to the nearest 0.1 kg) by height (in meters measured to the nearest 0.1 cm) squared.

Time frame: 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.

Systolic and diastolic blood pressure

Measured in a seated position after ten minutes of rest, with a standard sphygmomanometer. The measurement will be taken twice with 1 minute between measures, according to the gold standard for measuring blood pressure.

Time frame: 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.

Resting heart rate

Measured in a seated position following a 5 minute rest.

Time frame: 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.

Total cholesterol

Blood will be drawn following an overnight fast (minimum 8 hours, or else rescheduled). Measured as mmol/l.

Time frame: 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.

S-low density lipoprotein cholesterol

Blood will be drawn following an overnight fast (minimum 8 hours, or else rescheduled). Measured as mmol/l.

Time frame: 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.

S-high density lipoprotein cholesterol

Blood will be drawn following an overnight fast (minimum 8 hours, or else rescheduled). Measured as mmol/l.

Time frame: 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.

Lipoprotein (a)

Blood will be drawn following an overnight fast (minimum 8 hours, or else rescheduled). Measured as nmol/l.

Time frame: 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.

Fasting triglycerides

Blood will be drawn following an overnight fast (minimum 8 hours). Measured as mmol/l.

Time frame: 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.

Fasting plasma glucose

Blood will be drawn following an overnight fast (minimum 8 hours). Measured as mmol/l.

Time frame: 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.

Glycated hemoglobin

Blood will be drawn following an overnight fast (minimum 8 hours) (HbA1c, mmol/l). It reflects average plasma glucose over the previous 8-12 weeks.

Time frame: 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.

Thyroid stimulating hormone (TSH)

Blood will be drawn following an overnight fast (minimum 8 hours). Measured as mE/L.

Time frame: 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.

Cobalamin

Blood will be drawn following an overnight fast (minimum 8 hours). Reflects vitamin B12 status. Measured in pmol/L.

Time frame: 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.

Homocysteine

Blood will be drawn following an overnight fast (minimum 8 hours). Measured in µmol/L.

Time frame: 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.

25-OHD-vitamin

Blood will be drawn following an overnight fast (minimum 8 hours). Main marker of vitamin D status in the body, reported in nmol/L.

Time frame: 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.

Folate

Blood will be drawn following an overnight fast (minimum 8 hours). Reported in nmol/L.

Time frame: 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.

Iron deposits: Iron

Blood will be drawn following an overnight fast (minimum 8 hours). Iron \[Fe\], reported in µmol/L.

Time frame: 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.

Iron deposits: Transferrin

Blood will be drawn following an overnight fast (minimum 8 hours). Reported in µg/L.

Time frame: 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.

High-sensitive C-reactive protein (CRP)

Blood will be drawn following an overnight fast (minimum 8 hours). Reported in mg/L.

Time frame: 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.

White blood cell telomere length

Blood will be drawn following an overnight fast (minimum 8 hours). Telomere length in leukocytes will be measured, reported as relative telomere length (T/S ratio).

Time frame: Baseline, week 14 after the start of the intervention (primary endpoint).

Inflammation panel

Blood will be drawn following an overnight fast (minimum 8 hours). Immune activity plasma proteins (n=92) will be analysed using the Olink Target 96 Inflammation panel.

Time frame: Baseline, week 14 after the start of the intervention (primary endpoint).

Extracellular vesicles (EVs)

Blood will be drawn following an overnight fast (minimum 8 hours). EVs will be isolated from plasma using differential ultracentrifugation. Quantification and separation of EVs will be performed using flow cytometry using antibodies specifically marking EVs with regards to being a microparticle and their tissue of origin. We will investigate the amount and origin of EVs from the vascular endothelium, leukocytes, platelets, and the skeletal muscle. To assess the cargo of particularly interesting EVs, RNA will be isolated and miRNA profiled using the robust and high-throughput nCounter (Nanostring).

Time frame: Baseline, week 14 after the start of the intervention (primary endpoint).

Biological age

Blood will be drawn following an overnight fast (minimum 8 hours). DNA will be extracted using the Chemagen kits on the Hamilton ChemagicSTAR® platform. Bisulfite conversion will be conducted using the EZ-96 DNA Methylation-Lightning Kit (D5033). The Illumina Infinium MethylationEPIC v.2 array will be used to quantify DNAm at \~930,000 sites. Raw methylation data will be pre-processed using standard quality control steps, including removal of low-quality probes (e.g., detection p-value \>0.01), background correction, and normalization. Biological aging patterns will be assessed through epigenetic age calculations using state-of-the-art algorithms (e.g., GrimAge). Accelerated biological age will be calculated as the residual from regressing epigenetic age on chronological age.

Time frame: Baseline, week 14 after the start of the intervention (primary endpoint).