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. 2019 Nov 22;2019(11):CD011287. doi: 10.1002/14651858.CD011287.pub2

Groarke 2018.

Trial name or title  
Methods Design: pilot randomised controlled trial retrospective
Country: Ireland
Accrual dates: NR
Trial Reg: ISRCTN18676721
Participants Overweight/obese cancer survivors
Interventions The study is employing a 2 groups (experimental and control) x 3 time points (baseline, 3 months, 6 months) mixed analysis of variance design to investigate the impact of a personalised solution (wear a Fitbit activity monitor, using a personalised dietary or physical activity intervention that will employ an educational component along with a shared decision‐making and goal‐setting model) vs standard care on primary and secondary health outcomes
Outcomes Primary outcomes:
Average daily step count, measured via Fitbit device continuously for 6 months
BMI and weight
Secondary outcomes:
Sleep quality, measured via Fitbit device continuously for 6 months
The following measures are recorded
Physical fitness, measured using 6‐minute walk test ‐ resting HR, BP, SpO2, recovery HR, BP, SpO2
Dietary behaviour, measured using Food Frequency Questionnaire
General health status (MOS SF‐36; Ware et al, 2000), fatigue (Mendoza, Wang, Cleeland, et al., 1999), self‐efficacy (Schwarzer & Jerusalem, 2010), exercise self‐efficacy (Bandura, 2006), exercise‐related social support (Sallis et al, 1987)
Starting date August 2017
Contact information Dr. Jenny Groarke, National University of Ireland, Galway
Notes Protocol