Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Use of the PreLiFe-programme assessed with app based tracking |
The use of the PreLiFe-programme is assessed in the intervention group by evaluating the % of participants using the PreLiFe-programme by app-based tracking. |
at 3 months, 6 months, 9 months and 12 months after randomisation |
|
| Other |
Acceptability of the PreLiFe-programme assessed with a subscale of the Mobile App Rating Scale (MARS) |
The acceptability of the PreLiFe-programme is assessed at the end of the study in the intervention group with a shortened version of the subjective quality subscale of the Mobile App Rating Scale (MARS)(score 0-10 with the higher the better subjective quality of the PreLiFe-programme). |
12 months |
|
| Other |
Partners' support assessed with a questionnaire |
The partner's support during the PreLiFe-programme is assessed in the intervention group with a self-developed questionnaire to evaluate if they feel supported by their partner in maintaining a healthy lifestyle.This self-developed questionnaire is based on "The Social Support for Diet and Exercise scale of Sallis et al. (1987). It consists of 3 subscales: partners' support for diet (0-10), physical activity (0-15) and personal wellbeing (0-10), with the higher the better the partner's support. |
at 3 months, 6 months, 9 months and 12 months after randomisation |
|
| Other |
Occurrence of adverse events |
Differences in the occurrence of adverse events (data obtained from medical records) between the intervention and attention control group are evaluated. |
12 months |
|
| Primary |
Cumulative ongoing pregnancy rate (COPR) within 12 months after randomisation |
Ongoing pregnancy is defined as a viable intrauterine pregnancy of at least 12 weeks duration confirmed on ultrasound scan. All pregnancies (Spontaneous and IVF pregnancies) conceived within these 12 months are followed up until the 12 weeks ultrasound scan. IVF-discontinuation is described as couples undergoing IVF who do not return for a further IVF cycle in our fertility centres after the failure of a previous cycle. Ongoing pregnancy within 12 months after randomisation is counted as a positive event, whereas IVF discontinuation and absence of pregnancy are counted as a negative event. Differences in COPR will be evaluated between the intervention and attention control group. |
12 months |
|
| Secondary |
Changes in diet assessed with a Food Frequency Questionnaire (FFQ) |
A validated food frequency questionnaire (FFQ) is used to evaluate changes in dietary pattern and diet quality over time and to evaluate differences in the dietary pattern and diet quality between the intervention and attention control group. The FFQ consists of a finite list of foods and beverages with response categories to indicate usual frequency and portion size of consumption over the last month. Diet quality is calculated from the FFQ by assessing quality, balance and variety of foods and beverages consumed (score 0-100 with the higher the better diet quality). Diet quality is an index to reflect compliance with the Belgian Food Based Dietary Guidelines. |
at baseline, 3 months, 6 months, 9 months and 12 months after randomisation |
|
| Secondary |
Changes in physical activity assessed with the International Physical Activity Questionnaire (IPAQ) |
The International Physical Activity Questionnaire Short Form (IPAQ-SF) is used to evaluate changes in physical activity over time and to evaluate differences in physical activity between the intervention and attention control group. The IPAQ-SF assesses the duration (in minutes) and frequency (in days) of walking, moderate-intensity activities, vigorous-intensity activities and sedentary activity (sitting) based on metabolic equivalent (MET) values. Self-reported physical activity is classified as low, moderate or high physically active based on the global recommendations on physical activity for health of the World Health Organisation. The IPAQ-SF is a reliable and validated instrument for monitoring physical activity in population health surveillance systems. |
at baseline, 3 months, 6 months, 9 months and 12 months after randomisation |
|
| Secondary |
Changes in symptoms of emotional distress, anxiety and depression (personal wellbeing) assessed with the Depression, anxiety and stress scale (DASS-21) |
The Depression, anxiety and stress scale (DASS-21) is used to evaluate changes in personal wellbeing over time and to evaluate differences in personal wellbeing between the intervention and attention control group. Self-reported symptoms of stress, anxiety and depression (together emotional distress) are measured with this validated scale (score 0-126 with the lower, the higher personal wellbeing). |
at baseline, 3 months, 6 months, 9 months and 12 months after randomisation |
|
| Secondary |
Changes in fertility related quality of life assessed with the Fertility Quality of Life Tool (FERTIQOL). |
The Fertility Quality of Life Tool (FERTIQOL) is used to evaluate changes in fertility related quality of life over time and to evaluate differences in fertility related quality of life between the intervention and attention control group. Self-reported fertility related quality of life is measured with this validated scale (score 0-100 with the higher, the better fertility related quality of life). |
at baseline, 3 months, 6 months, 9 months and 12 months after randomisation |
|
| Secondary |
Changes in Body Mass Index (BMI) |
Weight and height are measured according to International Standards for Anthropometric Assessment. Weight is measured when wearing light clothes and no shoes on a calibrated scale. Height is measured without shoes on a stadiometer. Weight and height allow body mass index (BMI) calculation. Changes in BMI over time and differences in BMI between the intervention and attention control group are evaluated. |
at baseline, 3 months, 6 months, 9 months and 12 months after randomisation |
|
| Secondary |
Changes in waist circumference measured with a measuring tape |
Waist circumference is measured according to International Standards for Anthropometric Assessment with a SECA measuring tape to estimate abdominal fat. Changes in waist circumference over time and differences in waist circumference between the intervention and attention control group are evaluated. |
at baseline, 3 months, 6 months, 9 months and 12 months after randomisation |
|
| Secondary |
Number of clinical pregnancies |
Clinical pregnancy defined as evidence of a gestational sac confirmed by ultrasound. Dichotomous outcome (yes-no). Differences in number of clinical pregnancies between the intervention and attention control group are evaluated. |
12 months |
|
| Secondary |
Time to pregnancy |
Differences in time to pregnancy between the intervention and attention control group are evaluated. |
12 months |
|
