Table 3. Treatment effect for primary and secondary outcomes at 26 weeks.
End point | Treatment effect estimate (95% CI) | p-Value | Analysis method |
---|---|---|---|
Primary | |||
Trunk fat mass, kg | −0.9 (−1.6 to −0.3) | 0.0073 | Linear regression |
SF36 Perfect Physical Functioning | 0.77 (−0.30 to 1.97) | 0.14 | Repeated measures logistic regression |
Secondary | |||
Whole-body fat mass, kg | −1.8 (−2.9 to −0.7) | 0.0016 | Linear regression |
Lean body mass, kg | 1.5 (0.9–2.1) | <0.001 | |
Bone density, g/cm2 | 0.00 (−0.01 to 0.01) | 0.42 | |
Ln(fasting insulin:glucose ratio) | −0.06 (−0.30 to 0.19) | 0.65 | |
High-density lipoprotein, mmol/l | 0.01 (−0.17 to 0.18) | 0.93 | |
Low-density lipoprotein, mmol/l | −0.05 (−0.27 to 0.17) | 0.68 | |
Total cholesterol, mmol/l | −0.03 (−0.26 to 0.21) | 0.83 | |
Ln(triglycerides) | −0.00 (−0.15 to 0.15) | 0.99 | |
BMI, kg/m2 | −0.17 (−0.58 to 0.24) | 0.34 | Repeated measures linear regression |
Waist circumference, cm | 0.16 (−1.81 to 2.13) | 0.87 | |
SF36 physical component summary | −0.98 (−2.86 to 0.90) | 0.30 | |
SF36 mental component summary | 0.16 (−3.49 to 3.82) | 0.93 | |
FACIT Fatigue | −0.63 (−3.40 to 2.13) | 0.65 | |
RSE self-esteem | −0.40 (−1.99 to 1.20) | 0.63 |
Abbreviations: BMI, body mass index; FACIT, Functional Assessment of Chronic Illness Therapy; Ln, natural log; RSE, Rosenberg Self-Esteem