Metabolic risk management, physical exercise and lifestyle counselling in low-active adults: controlled randomized trial (BELLUGAT)

Table 3 BELLUGAT protocol schedule form and procedures for all interventions

Time point	Enrolment	Baseline assessment	Allocation	+16 weeks assessment	+24 weeks assessment
Time point	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

ISSN: 1471-2458