McDonald 2014.
Trial name or title | The muscle mass, omega‐3, diet, exercise and lifestyle (MODEL) study – a randomised controlled trial for women who have completed breast cancer treatment |
Methods | Design: Single‐centre RCT N = 144 (target) Follow‐up: 12 and 24 weeks from baseline |
Participants | Major Inclusion criteria: Stage 0‐3a breast cancer survivor, completed treatment more than 6 week but within 1 year, BMI between 20 and 35. |
Interventions | Intervention: arms 1 and 2 E1 (N‐3 group): daily consumption of LCn‐3 FAs for 24 weeks E2 (EX+N‐3 group): daily consumption of LCn‐3 FAs for 24 weeks plus a supervised 12‐week exercise and nutrition group education programme; conducted by dietitian and accredited exercise physiologist C: Placebo supplementation |
Outcomes | Quality of life: Functional Assessment of Cancer Therapy‐Breast + 4 (FACT‐B + 4) Others: Body composition: Air displacement plethysmography, Adherence to exercise and dietary programme: Active Australia Survey, 7‐d Uniaxial accelerometry and exercise log (Exercise); Dietary Habits Questionnaire; Attendance at sessions; HAQ‐DI; Menopausal symptoms: Greene Climacteric Scale |
Starting date | NS |
Contact information | MacDonald C: c.mcdonald4@uq.edu.au |
Notes | E1: Experimental group 1; E2: Experimental group 2, C: comparison, RCT: randomised control trial; HAQ‐DI: Body composition: Air displacement plethysmography. Funding for the study was put forward by the Wesley Research Institute, this funding covered blood analyses, purchase of necessary equipment and payment for research assistance when required. The authors acknowledge that all capsules were provided gratis by Blackmores Ltd, Australia. In addition, GymStick provided exercise equipment for all participants at cost price. Parties associated with the supply of capsules and exercise equipment have no part in the research design, administration, analyses and subsequent publications. |