Table 3.
BELLUGAT protocol schedule form and procedures for all interventions
| Time point | Enrolment | Baseline assessment | Allocation | +16 weeks assessment | +24 weeks assessment |
|---|---|---|---|---|---|
| t-1 | t0 | t1 | t2 | ||
| Preliminary data: | |||||
| Eligibility screen | ✔ | ||||
| Informed consent | ✔ | ||||
| Allocation | ✔ | ||||
| Anthropometric measurements | |||||
| Body mass | ✔ | ✔ | ✔ | ||
| Height | ✔ | ✔ | ✔ | ||
| Body mass index | ✔ | ✔ | ✔ | ||
| Waist circumference | ✔ | ✔ | ✔ | ||
| Hip circumference | ✔ | ✔ | ✔ | ||
| Blood sampling and biochemical measurements | |||||
| Lipid profile (TG, TC, HDLc, LDLc) | ✔ | ✔ | ✔ | ||
| Plasma glucose | ✔ | ✔ | ✔ | ||
| Plasma glycated haemoglobin | ✔ | ✔ | ✔ | ||
| Plasma adiponectin | ✔ | ✔ | ✔ | ||
| Plasma Interleucin-6 | ✔ | ✔ | ✔ | ||
| Plasma metabolome-lipidome | ✔ | ✔ | ✔ | ||
| Plasma MicroRNA | ✔ | ✔ | ✔ | ||
| Medical procedures | |||||
| Resting blood pressure | ✔ | ✔ | ✔ | ||
| Cardiorespiratory fitness (VO2peak) | ✔ | ✔ | ✔ | ||
| Physical activity and sedentary behaviour | |||||
| Physical activity (LPA and MVPA) | ✔ | ✔ | ✔ | ||
| Sedentary time | ✔ | ✔ | ✔ | ||
| Self-reported Questionnaires | |||||
| Food frequency questionnaire | ✔ | ✔ | ✔ | ||
| Healthy eating index | ✔ | ✔ | ✔ | ||
| Empowerment related to health | ✔ | ✔ | ✔ | ||
| Physical activity and dietary habits self-efficacy | ✔ | ✔ | ✔ | ||
| Health related quality of life (EQ-5D) | ✔ | ✔ | ✔ | ||
| Direct costs | ✔ | ||||
| Indirect costs | ✔ | ||||
| Demographic variables | ✔ | ||||
| Enjoyment with the programme | ✔ | ||||
| Reasons for abandoning | ✔ | ✔ | ✔ | ||
EQ-5D EQ-5D questionnaire, HDLc High Density Lipoprotein cholesterol, LDLc Low Density Lipoprotein cholesterol, LPA Light Physical Activity, miRNA microRNA, MVPA Moderate-to-Vigorous Physical Activity, TC Total Cholesterol, TG Triglycerides, VO 2peak Peak Oxygen uptake