Table 4.
Primary and secondary outcome measures for RCT1, RCT2 and the longitudinal cohort study for index participants and for household/whānau members.
| Outcome variables | RCT 1 | RCT 2 | LCS | Proposed analysis |
|---|---|---|---|---|
| Primary outcome | ||||
| MetSSS | X | X | X | ANCOVA with baseline measurements as covariate, see text for details of sensitivity analysis confounders and sub-group |
| Secondary outcomes | ||||
| Weight | X | X | X | ANCOVA with baseline measurements as covariate |
| Body mass index | X | X | X | ANCOVA with baseline measurements as covariate, consideration of logarithm transformation |
| Lean mass (FFM calculated from BIA and DXA measurements) | X | X | X | ANCOVA with baseline measurements as covariate |
| Fat mass (calculated from BIA and DXA Measurements) | X | X | X | ANCOVA with baseline measurements as covariate |
| Dietary pattern measured using Food Frequency Questionnaire | X | X | X | |
| Individual components of MetSSS | ||||
| Glucose | X | X | X | ANCOVA with baseline measurements as covariate |
| Triglycerides | X | X | X | ANCOVA with baseline measurements as covariate, consideration of logarithm transformation |
| HDL cholesterol | X | X | X | ANCOVA with baseline measurements as covariate |
| Systolic blood pressure | X | X | X | ANCOVA with baseline measurements as covariate |
| Waist circumference | X | X | X | ANCOVA with baseline measurements as covariate |
| HbA1c | X | X | X | ANCOVA with baseline measurements as covariate |
| Insulin | X | X | X | ANCOVA with baseline measurements as covariate, consideration of logarithm transformation |
| HOMA | X | X | X | ANCOVA with baseline measurements as covariate, consideration of logarithm transformation |
| Total cholesterol | X | X | X | ANCOVA with baseline measurements as covariate |
| LDL cholesterol | X | X | X | ANCOVA with baseline measurements as covariate |
| Diastolic BP | X | X | X | ANCOVA with baseline measurements as covariate |
| hsCRP | X | X | X | Mann–Whitney test with Hodges Lehmann estimator |
| Quality of life | ||||
| SF36 (MCS and PCS and all dimensions) | X | X | X | ANCOVA with baseline measurements as covariate |
| Kaupapa Māori Wellbeing questionnaire | X | X | X | Analyzed and reported separately |
| Online engagement metrics | X | X | Count scores | |
| Self-evaluation COM Questionnaire | X | X | X | Count scores |
| Impact evaluation | X | X | X | Qualitative thematic analysis |
LCS, longitudinal cohort study; MetSSS, metabolic syndrome severity score; FFM, fat free mass; BIA, bioelectrical impedance; DXA, dual-energy X-ray absorptiometry; HDL, high density lipoprotein; HOMA, homeostatic model assessment; LDL, low density lipoprotein; hsCRP, high sensitivity C reactive protein; MCS, mental component summary; PCS, physical component summary.