Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Recruitment |
Recruitment rates will be calculated as the proportion of patients randomised/proportion of patients eligible |
Assessed at 3 months after baseline |
|
Primary |
Retention |
Retention rates will be calculated as the proportion of patients providing the outcomes of interest/proportion of patients randomised |
Assessed at 5 months (20 weeks) |
|
Primary |
Intervention adherence |
Adherence to intervention protocol will be calculated as the number of group and motivational counselling sessions attended out of the total number of sessions available |
Assessed at 5 months (20 weeks) |
|
Primary |
Intervention acceptability |
Acceptability of intervention protocol will be calculated as the number of received optional elements of the intervention out of the total number of optional intervention elements available |
Assessed at 5 months (20 weeks) |
|
Secondary |
Objectively measured physical activity measured by SENS monitor |
The SENS Motion sensor is an activity sensor, which captures seven-day, 24-hour physical activity patterns, including number of steps and the amount of daily time lying down, sitting, standing, and being active with light, moderate and high intensity, as well as specific activities such as bicycling or walking stairs |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
Self-reported physical activity and sitting time measured by the Physical Activity Scale (PAS) |
Self-reported physical activity (light, moderate, vigorous) and sitting time at work and during leisure time will be measured by the Physical Activity Scale 2.1 (PAS 2.1). Participants will be asked to specify number of hours and minutes in an average 24-hour day spent sitting at work and during leisure time. In addition, participants will report number of weekly hours and minutes spent in light, moderate or vigorous intensity activities. |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
Exercise self-efficacy measured by the Exercise Self-Efficacy Scale |
The Exercise Self-Efficacy Scale assesses an individual's beliefs in their ability to continue exercising under different circumstances. |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
Health-related quality of life measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) |
Quality of life will be measured by the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32). The IBDQ-32 captures the patient's experience of IBD on four domains of functioning and well-being: 1) bowel symptoms, 2) systemic symptoms, 3) emotional function and 4) social function. |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
Fatigue measured by The Multi-dimensional Fatigue Inventory (MFI-20) |
Fatigue will be measured by the 20-item Multi-dimensional Fatigue Inventory (MFI 20) . MFI 20 consists of 20 statements, which classifies fatigue in five dimensions: 1) general fatigue 2) physical fatigue 3) mental fatigue 4) reduced activity 5) reduced motivation. |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
Fatigue measured by the visual analogue scale for fatigue (VAS-Fatigue) |
Fatigue measured by the visual analogue scale for fatigue (VAS-fatigue). Score from 0-100. Higher score is more fatigue. |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
Pain intensity measured by the visual analogue scale for pain (VAS-Pain) |
Pain will be measured by the visual analogue scale for pain. Score from 0-100. The higher score, the higher pain intensity. |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
Mental health measured by The Hospital Anxiety and Depression Scale (HADS) questionnaire |
The HADS questionnaire consists of seven items for depression and anxiety subscales, respectively. Scoring for each item ranges from zero to three, with three indicating highest anxiety or depression level. |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
IBD-related disease activity measured by fecal calprotectin |
Fecal calprotectin is a stool test that is used to detect inflammation in the intestines. It will be used to monitor the participants' disease activity and severity. |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
Serum lipids measured by blood sample |
Total cholesterol, high-density lipoprotein cholesterol (HDL), and triglycerides will be measured by a blood sample. Low-density lipoprotein cholesterol (LDL) will be calculated. |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
Glycosylated hemoglobin (HbA1c) measured by blood sample |
Glycosylated hemoglobin, type A1c (HbA1c) will be determined by a blood sample |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
Disease activity measured by a C-Reactive Protein (CRP) test |
A venous blood sample will be drawn (not fasting) |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
Blood pressure measurements |
Blood pressure will be measured, after 5 to 10 minutes of rest, 3 times at the right upper arm (average of the 3 measurements) with the participant in a sitting/lying position. |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
Body weight in kilograms |
Body weight is measured in light clothing without shoes to the nearest 0.1 kg |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
Waist circumference measured in centimeters |
Waist circumference will be measured midway between the lower rib margin and the iliac crest to the nearest 0.5 centimeter, without any pressure to the skin and with an unstretched tape measure. |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
Hip circumference measured in centimeters |
Hip circumference will be measured at the point yielding the maximum circumference over the buttocks to the nearest 0.5 centimeter. The tape measure will be be held in a horizontal plane touching the skin but not indenting the soft tissue. |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
Waist-hip-ratio |
Waist-hip-ratio will be calculated based on the assessments of waist and hip circumferences |
Assessed at baseline and at 5 months (20 weeks) |
|
Secondary |
Body mass Index (BMI) |
Body mass Index (BMI, kg/m2) will be calculated based on the assessment of body weight and height. |
Assessed at baseline and at 5 months (20 weeks) |
|