Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2018
INTERVENTION: 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 versus standard care on primary and secondary health outcomes. Participants are randomly allocated to control or intervention group. Participants in the intervention condition will wear a Fitbit activity monitor for the duration of the 6‐month study. Summary data will be visible on the tracker’s display and additional physical activity (step count) and sleep data will be available on the Fitbit application for the study condition. The FitBit device allows for an assessment of the behaviour change strategies of self‐monitoring, combined with other self‐regulatory skills (e.g., goal setting, frequent behavioural feedback) (Cadmus‐Bertram, et al., 2015). The experimental group will received a personalised dietary and physical activity intervention which will employ an educational component along with a shared decision‐making and a goal‐setting model. The self management programme is interdisciplinary in nature and will be delivered by a host of healthcare professionals (Nurses, Physiotherapists, Dieticians, and Psychologists). Participants will attend group educational sessions (n=15 approx per group). In these sessions, lifestyle education and advice will be given with an opportunity for individualised advice/support. This self‐management programme will provide the structure for interventions to include imparting knowledge, empowering an individual to make lifestyle change, motivating behavioural change and sustaining such positive lifestyle choices going forward. Weekly goals and overall targets for physical activity will be agreed and established for each subject (increase daily step count by 10% each week). Participants in the intervention group will receive an SMS on week 2, 3, 6, 8 and 12 providing review and feedback on physical activity goals. Participants in the c CONDITION: Overweight/obese cancer survivors ; Nutritional, Metabolic, Endocrine ; Obesity PRIMARY OUTCOME: 1. Average daily step count, measured via Fitbit device continuously for 6 months; 2. BMI and weight, recorded at baseline, three month follow‐up (Time 1), and six month follow‐up (Time 2) SECONDARY OUTCOME: 1. Sleep quality, measured via Fitbit device continuously for 6 months; The following measures are recorded at baseline, three month follow‐up (Time 1), and six month follow‐up (Time 2):; 2. Physical fitness, measured using 6‐minute walk test ‐ resting HR, BP, Sp02, recovery HR, BP, Sp02; 3. Dietary behaviour, measured using Food Frequency Questionnaire (Mulligan, Luben, Bhaniani et al., 2014); 4. 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) INCLUSION CRITERIA: Adults with a solid cancer diagnosis with a calculated BMI > 25 post completion of acute cancer treatment who attend Oncology in Letterkenny University Hospital during the recruitment phase
Epistemonikos ID: 817e4e6214498457b47cb2d2e2fd463b156dcc63
First added on: Aug 24, 2024