Category
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Primary study
Registry of Trials»ANZCTR
Year
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2024
INTERVENTION: This study will use a two‐arm parallel pragmatic hybrid type I effectiveness‐implementation randomised controlled trial (n=1000) to test the effectiveness of the Active Women over 50 program on daily steps at 6 months compared with waitlist control among women aged 50+. Women participants aged 50 years and over will be randomly allocated in equal numbers to: a) Immediate participation in the Active Women over 50 program (intervention group), n=500 or b) Delayed participation in the Active Women over 50 program, waitlist control (control group, n=500) Intervention components The intervention group will receive immediate access to the Active Women over 50 program. The Active Women over 50 program is a remotely delivered program designed with input from end‐users across urban, regional and rural geographical settings and consists of four parts: 1) telephone‐based health coaching, 2) email or SMS behaviour change messages, 3) Active Women over 50 website, and 4) access to the Active Women over 50 private Facebook group. Health coaching Participants will receive two health coaching sessions, lasting up to 60 minutes, delivered by telephone or videoconference as preferred by the participant. The health coach will be a tertiary‐qualified physiotherapist or other health professional trained and experienced in delivering empowerment‐focused coaching to facilitate physical activity behaviour change. The first coaching session will take place within 2 weeks of randomisation, and the second session four weeks after the first. This person‐centred health coaching approach will provide information and education about physical activity. The sessions will also draw on evidence‐based behaviour change techniques, practice and theories to help participant CONDITION: Physical inactivity; ; Physical inactivity Public Health ‐ Health promotion/education PRIMARY OUTCOME: Physical activity (average steps per day).[Number of steps measured objectively with an ActiGraph accelerometer (ActiGraph GT3X+) over a 7‐day period. Baseline and 6 months post‐randomisation.] INCLUSION CRITERIA: The trial will involve consenting women who: • are aged 50 years and over • live in the community across NSW • do not meet the moderate‐vigorous physical activity (MVPA) guidelines • have access to an internet connected device • want to receive support to be more active SECONDARY OUTCOME: Action Planning and Coping Planning[Action Planning and Coping Planning questionnaire Baseline and 6 months post‐randomisation.] Balance[Self‐perceived balance: (“How would you rate your balance: excellent, very good, good, fair, or poor”) ; Baseline and 6 months post‐randomisation.] Bodily pain[PROMIS SF v2.0 – Pain interference and Pain intensity 4a Baseline and 6 months post‐randomisation.] Falls rate[Monthly health diaries. This is an adaptation of a validated source as falls are not the primary outcome. Monthly for 6 months ‐ starting at baseline and ending 6 months post‐randomisation.] Fear of falling[Response to single item question (“Are you afraid of falling? (1 = not at all, 2 = little bit, 3 = moderately, 4 = quite a lot, 5 = extremely”) Baseline and 6 months post‐randomisation.] Health and community service use[Monthly health diaries Monthly for 6 months ‐ starting at baseline and ending 6 months post‐randomisation.] Individualised goal attainment [Goal Attainment Scale Baseline and 6 months post‐randomisation.] Menopause symptoms[Assessed by Physical and Psychosocial subscales of the menopause‐specific quality of life questionnaire (MENQOL) Baseline and 6 months post‐randomisation] Mental wellbeing[Warwick‐Edinburgh Mental Well‐being Scale Baseline and 6 months post‐randomisation.] Participation in strength and balance training,[Assessed using the question "How many days per week do you perform in muscle‐strengthening activities and balance and functional training?" Baseline and 6 months post‐randomisation] Physical function[PROMIS SF v2.0 – Physical Function 4a Baseline and 6 months post‐randomisation.] Proportion achieving light physical activity/week.[Actigraph accelerometer worn over a 7‐day period Baseline and 6 months post‐randomisation.] Proportion achieving lower limit MVPA/week[Actigraph accelerometer worn over a 7‐day period Baseline and 6 months post‐randomisation.] Proportion of participants who increased 2000+ steps from baseline using ActiGraph GT3X+ over a 7‐day period[Wearing ActiGraph GT3X+ over a 7‐day period Baseline and 6 months post‐randomisation] Quality of life[EuroQol EQ‐5D‐5L Baseline and 6 months post‐randomisation.] Self‐reported physical activity[self‐reported physical activity assessed with the single‐item question "In the past week, on how many days have you done a total of 30 minutes or more of physical activity, which was enough to raise your breathing rate. This may include sport, exercise, and brisk walking or cycling for recreation or to get to and from places, but should not include housework or physical activity that may be part of your job". Baseline and 6 months post‐randomisation.] Sleep[Pittsburgh Sleep Quality Inde X(PSQI) Baseline and 6 months post‐randomisation.]
Epistemonikos ID: b42a563d0303f554a408e4c21827ab65875a8749
First added on: Aug 28, 2024