Table 1.
Data collection procedures in the MELINDA trial.
| Outcomes | Assessments | Timing of Assessments | ||||||
|---|---|---|---|---|---|---|---|---|
| Baseline | 1 Month * | Monthly * (Month 2 to 11) | 3 Months * | 6 Months * | 9 Months * | 12 Months ** | ||
| Outcomes Collected from Medical Records | ||||||||
| Demographic data | Age; date of birth | x | ||||||
| Medical and obstetric history | Pre-pregnancy weight and BMI; weight at delivery; parity; previous pregnancy outcomes | x | ||||||
| Patient-Reported Outcomes | ||||||||
| General lifestyle behaviour and socio-economic factors | Self-constructed questionnaire | x | ||||||
| Medication use | Questioned by study nurse | x | x | x | x | x | x | x |
| Diet | Food Frequency Questionnaire (FFQ) | x | x | x | x | x | ||
| Physical activity | International Physical Activity Questionnaire Long Form (IPAQ-LF) | x | x | |||||
| Mental health and well-being | Center for Epidemiologic Studies -Depression (CES-D) questionnaire and Spielberger State-Trait Anxiety Inventory (STAI-6) questionnaire | x | x | |||||
| Quality of life | 36-Item Short Form Health Survey (SF-36) | x | x | |||||
| Diabetes risk perception | Risk Perception Survey for Developing Diabetes (RPS-DD) | x | x | |||||
| Motivation for lifestyle change | Treatment Self-Regulation Questionnaire (TSRQ) | x (v2) | x (v3) | |||||
| Breastfeeding and anticonception | Self-constructed questionnaire | x | x | |||||
| Sense of coherence | Sense of Coherence (SOC) questionnaire | x | x | |||||
| Acceptability and subjective quality of the lifestyle intervention | Self-constructed questionnaire | x | ||||||
| Clinical and Biochemical Outcomes | ||||||||
| Anthropometry | Height (only baseline), weight, waist circumference, blood pressure, BMI | x | x | |||||
| Glucose and insulin | Fasting 75 g OGTT (0, 30, 60 and 120 min) | x | x | |||||
| HbA1c | Fasting | x | x | |||||
| Lipid profile | Total cholesterol, triglycerides, HDL, LDL (fasting) | x | x | |||||
| Outcomes Collected from the MELINDA App | ||||||||
| Weight | Self-reported weight in the MELINDA app | x | ||||||
| Motivational status | Self-reported motivational status in the MELINDA app | x | ||||||
| Waist circumference | Self-reported waist circumference in the MELINDA app | x | x | x | ||||
| Physical activity | Steps collected from pedometer connected to Melinda app | x | ||||||
| Use of the MELINDA app | App-based tracking to evaluate the use of the MELINDA app | x | x | |||||
* Only for participants in the intervention group of the randomized control trial (RCT); ** Only for participants in the intervention group and control group of the RCT.