Table 1.
Outcomes and timeline
| Assessments | Screening visit | Baseline visit | Midpoint visit (26/27 weeks) | Year 1 visit | Year 2 visit (follow-up) | Year 3 visit (follow-up) | Year 4 visit (follow-up) endpoint |
|---|---|---|---|---|---|---|---|
| Lab tests | |||||||
| OGTT test | X | X | X | X | |||
| Height, weight and blood pressure measurements | X | X | X | X | X | X | X |
| Bio-sample collection: buccal swab, saliva, and stool samples | X | X | X | ||||
| BIA | X | X | X | X | X | ||
| Fasting blood draw | X | X | X | X | X | X | |
| Questionnaires | |||||||
| Demographics | X | X | |||||
| GDM and family history of diabetes | X | ||||||
| Spouse and child health | X | X | |||||
| Lifestyle and dietary | X | X | |||||
| Diabetes awareness | X | X | |||||
| 14-day e-Diary recording | X | X | X | X | X | X | |
| SF-36 | X | X | X | X | X | X | |
| STAI | X | X | X | X | X | X | |
| BDI-II | X | X | X | X | X | X | |
| CERQ | X | X | X | X | X | X | |
| MEQ | X | X | X | X | X | X | |
| PSQI | X | X | X | X | X | X | |
| SHS | X | X | X | X | X | X | |
| HLQ | X | X | X | X | X | X | |
| PSS-4 | X | X | X | X | X | X | |
| WHO-5 | X | X | X | X | X | X | |
| Child-related questionnaires | |||||||
| BISQ-R-SF | X | X | |||||
| CSHQ | X | X | |||||
| StimQ toddler/preschool | X | X | X | X | X | ||
| ASQ-3 | X | X | X | X | X | ||
| BRIEF-2 | X | X | X | X | X | ||
| BASC-3-BESS Parent Form | X | X | X | X | X | ||
| Questionnaires administrated within the LvLUP App (intervention group only) | |||||||
| PHQ-4 | x | x | |||||
| IPAQ-SF | x | x | |||||
| MFFQ | x | x | |||||
OGTT 2-h 75 g oral glucose tolerance test, BIA Bioelectrical impedance analysis, SF-36 short-form health survey, STAI The Stare-Trait Anxiety Inventory, BDI-II Beck Depression Inventory, CERQ Cognitive Emotion Regulation Questionnaire, MEQ Morningness-Eveningness Questionnaire, PSQI The Pittsburgh Sleep Quality Index, SHS Subjective Happiness Scale, HLQ Health Literacy Questionnaire, PSS-4 Perceived Stress Scale 4, WHO-5 World Health Organization Wellbeing Index, BISQ-R-SF Brief Infant Sleep Questionnaire-Revised Short Form, CSHQ Children’s Sleep Habits Questionnaire, StimQ toddler/preschool Cognitive Home Environment Questionnaire, ASQ-3 Ages & Stages Questionnaires-3, BRIEF-2 Behaviour Rating Inventory of Execute Functions-2, BASC-3-BESS Parent Form Behavioral and Emotional Screening System, PHQ-4 Patient Health Questionnaire, IPAQ-SF The International Physical Activity Questionnaire-Short Form, MFFQ Modified Food Frequency Questionnaire