Table 5.
Study period timepoints | ||||||||
---|---|---|---|---|---|---|---|---|
Eligibility | Enrolment | Intervention and follow up | ||||||
Visit 1 Screening |
Visit 2 Baseline Enrolment |
Phone contact | Email Contact | Visit 3a Control only |
Visit 3b | Visit 4 | Visit 5 | |
RCT1 control group | Week 0 | Week 12 | Week 24 | Week 36 | Week 64 | |||
RCT1 intervention group | Week 2 | Week 6 | Week 12 | Week 24 | Week 52 | |||
Eligibility screen | ✓ | |||||||
Informed consent | ✓ | |||||||
Medical history | ✓ | |||||||
Education about RCT 1 and RCT 2 | ✓ | |||||||
Questionnaires | ||||||||
Otago short-form FFQ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
24 h dietary recall | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
IPAQ Physical activity | ✓ | ✓ | ✓ | ✓ | ✓ | |||
Kaupapa Māori Wellbeing questionnaire | ✓ | ✓ | ✓ | ✓ | ✓ | |||
Three factor eating questionnaire | ✓ | ✓ | ✓ | ✓ | ✓ | |||
Gastrointestinal symptom rating scale | ✓ | ✓ | ✓ | ✓ | ✓ | |||
Self-Evaluation COM questionnaire | ✓ | ✓ | ✓ | ✓ | ✓ | |||
Impact evaluation for nutrition and behavior change support | ✓ | ✓ | ✓ | ✓ | ||||
SF-36 quality of life | ✓ | ✓ | ✓ | ✓ | ✓ | |||
Assessments | ||||||||
Height | ✓ | |||||||
Clinical measurementsa | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Body composition | ✓ | ✓ | ✓ | ✓ | ✓ | |||
Current medications | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Adverse events | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Fasting blood samples b | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Fecal sample | ✓ | ✓ | ✓ | ✓ |
aWeight, waist circumference, height, blood pressure in triplicate. bHbA1c, fasting glucose, lipids and metabolites and hormones related to metabolic health Household/whanau members will attend visits 2, 3a/3b, 4, and 5.