Protocol for a cluster randomized controlled trial to study the effectiveness of an obesity and diabetes intervention (PASOS) in an immigrant farmworker population

Table 3 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)

	Allocation	Study period
	Allocation	Enrollment			Close-out
Timepoint	−t₁ − 0	0	Baseline (t ₀ )	Intervention (12 weeks)	3-month FU (t ₁ )	6-month FU (t ₂ )	1-year FU (t ₃ )	1.5-year FU (t ₄ )
Enrollment:
Allocation	X
Eligibility screen		X
Medical clearance (if applicable)		X
Informed consent			X
Intervention:
PASOS Intervention				X
Control group				X
Assessments:
Background / Demographics			X		X^a		X^a
Acculturation			X
Medical history			X		X^a		X^a
Clinical measures			X		X	X	X	X
Blood pressure			X		X	X	X	X
Height			X		X	X	X	X
Weight			X		X	X	X	X
Waist circumference			X		X	X	X	X
HbA1c			X		X		X
Cholesterol			X		X		X
Knowledge			X		X		X
Nutrition			X		X		X
Eating habits			X		X		X
Smoking habits			X		X^a		X^a
Alcohol consumption			X		X^a		X^a
Physical activity			X		X		X
Income			X
Health perception			X		X		X
Program satisfaction					X

ISSN: 1471-2458