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Promoting physical activity in a multi-ethnic population at high risk of diabetes: the 48-month PROPELS randomised controlled trial
Khunti K, Griffin S, Brennan A, Dallosso H, Davies MJ, Eborall HC, Edwardson CL, Gray LJ, Hardeman W, Heathcote L, Henson J, Pollard D, Sharp SJ, Sutton S, Troughton J, Yates T
BMC Medicine 2021 Jun 3;19(130):Epub
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Physical activity is associated with a reduced risk of type 2 diabetes and cardiovascular disease but limited evidence exists for the sustained promotion of increased physical activity within diabetes prevention trials. The aim of the study was to investigate the long-term effectiveness of the Walking Away programme, an established group-based behavioural physical activity intervention with pedometer use, when delivered alone or with a supporting mHealth intervention. METHODS: Those at risk of diabetes (nondiabetic hyperglycaemia) were recruited from primary care, 2013 to 2015, and randomised to (1) control (information leaflet); (2) Walking Away (WA), a structured group education session followed by annual group-based support; or (3) Walking Away Plus (WAP), comprising WA annual group-based support and an mHealth intervention delivering tailored text messages supported by telephone calls. Follow-up was conducted at 12 and 48 months. The primary outcome was accelerometer measured ambulatory activity (steps/day). Change in primary outcome was analysed using analysis of covariance with adjustment for baseline, randomisation and stratification variables. RESULTS: One thousand three hundred sixty-six individuals were randomised (median age 61 years, ambulatory activity 6,638 steps/day, women 49%, ethnic minorities 28%). Accelerometer data were available for 1,017 (74%) individuals at 12 months and 993 (73%) at 48 months. At 12 months, WAP increased their ambulatory activity by 547 (97.5% CI 211 to 882) steps/day compared to control and were 1.61 (97.5% CI 1.05 to 2.45) times more likely to achieve 150 min/week of moderate-to-vigorous physical activity. Differences were not maintained at 48 months. WA was no different to control at 12 or 48 months. Secondary anthropometric and health outcomes were largely unaltered in both intervention groups apart from small reductions in body weight in WA (approximately 1 kg) at 12- and 48-month follow-up. CONCLUSIONS: Combining a pragmatic group-based intervention with text messaging and telephone support resulted in modest changes to physical activity at 12 months, but changes were not maintained at 48 months. TRIAL REGISTRATION: ISRCTN83465245 (registered on 14 June 2012).

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