Behavioural interventions to promote physical activity in a multiethnic population at high risk of diabetes: PROPELS three-arm RCT

Abstract

BACKGROUND: Type 2 diabetes is a leading cause of mortality globally and accounts for significant health resource expenditure. Increased physical activity can reduce the risk of diabetes. However, the longer-term clinical effectiveness and cost-effectiveness of physical activity interventions in those at high risk of type 2 diabetes is unknown. OBJECTIVES: To investigate whether or not Walking Away from Diabetes (Walking Away) - a low-resource, 3-hour group-based behavioural intervention designed to promote physical activity through pedometer use in those with prediabetes - leads to sustained increases in physical activity when delivered with and without an integrated mobile health intervention compared with control. DESIGN: Three-arm, parallel-group, pragmatic, superiority randomised controlled trial with follow-up conducted at 12 and 48 months. SETTING: Primary care and the community. PARTICIPANTS: Adults whose primary care record included a prediabetic blood glucose measurement recorded within the past 5 years [HbA(1c) ≥ 42 mmol/mol (6.0%), < 48 mmol/mol (6.5%) mmol/mol; fasting glucose ≥ 5.5 mmol/l, < 7.0 mmol/l; or 2-hour post-challenge glucose ≥ 7.8 mmol/l, < 11.1 mmol/l] were recruited between December 2013 and February 2015. Data collection was completed in July 2019. INTERVENTIONS: Participants were randomised (1 : 1 : 1) using a web-based tool to (1) control (information leaflet), (2) Walking Away with annual group-based support or (3) Walking Away Plus (comprising Walking Away, annual group-based support and a mobile health intervention that provided automated, individually tailored text messages to prompt pedometer use and goal-setting and provide feedback, in addition to biannual telephone calls). Participants and data collectors were not blinded; however, the staff who processed the accelerometer data were blinded to allocation. MAIN OUTCOME MEASURES: The primary outcome was accelerometer-measured ambulatory activity (steps per day) at 48 months. Other objective and self-reported measures of physical activity were also assessed. RESULTS: A total of 1366 individuals were randomised (median age 61 years, median body mass index 28.4 kg/m(2), median ambulatory activity 6638 steps per day, women 49%, black and minority ethnicity 28%). Accelerometer data were available for 1017 (74%) and 993 (73%) individuals at 12 and 48 months, respectively. The primary outcome assessment at 48 months found no differences in ambulatory activity compared with control in either group (Walking Away Plus: 121 steps per day, 97.5% confidence interval -290 to 532 steps per day; Walking Away: 91 steps per day, 97.5% confidence interval -282 to 463). This was consistent across ethnic groups. At the intermediate 12-month assessment, the Walking Away Plus group had increased their ambulatory activity by 547 (97.5% confidence interval 211 to 882) steps per day compared with control and were 1.61 (97.5% confidence interval 1.05 to 2.45) times more likely to achieve 150 minutes per week of objectively assessed unbouted moderate to vigorous physical activity. In the Walking Away group, there were no differences compared with control at 12 months. Secondary anthropometric, biomechanical and mental health outcomes were unaltered in either intervention study arm compared with control at 12 or 48 months, with the exception of small, but sustained, reductions in body weight in the Walking Away study arm (≈ 1 kg) at the 12- and 48-month follow-ups. Lifetime cost-effectiveness modelling suggested that usual care had the highest probability of being cost-effective at a threshold of £20,000 per quality-adjusted life-year. Of 50 serious adverse events, only one (myocardial infarction) was deemed possibly related to the intervention and led to the withdrawal of the participant from the study. LIMITATIONS: Loss to follow-up, although the results were unaltered when missing data were replaced using multiple imputation. CONCLUSIONS: Combining a physical activity intervention with text messaging and telephone support resulted in modest, but clinically meaningful, changes in physical activity at 12 months, but the changes were not sustained at 48 months. FUTURE WORK: Future research is needed to investigate which intervention types, components and features can help to maintain physical activity behaviour change over the longer term. TRIAL REGISTRATION: Current Controlled Trials ISRCTN83465245. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 77. See the NIHR Journals Library website for further project information.; When someone has type 2 diabetes, it means that their body no longer does a good job of controlling the sugar in their blood. This gives them a higher risk of other health problems. Fortunately, people can avoid getting type 2 diabetes if they can change their lifestyle. We wanted to know whether or not an education programme could help people at high risk of getting diabetes to become more physically active and, if so, whether or not they were still more active and healthier 4 years later. We also wanted to know whether it made a difference if we used text messages and telephone calls to support them and whether it worked better for some ethnic groups than others. We put 1366 people into one of three groups at random. The first group received an advice leaflet. The second group attended (in groups of up to 10 participants) a 3-hour education programme called ‘Walking Away from Type 2 Diabetes’ to help them to change their behaviour and then attended a group-based refresher session every year. The third group received the same education programme and the refresher sessions, but also received text messages and telephone calls to give them extra support. We measured how active the participants were at the start of the study, after 1 year and again 3 years after that (i.e. 4 years after the start). Then we looked at whether or not the Walking Away programme, with and without the extra support of text messages and telephone calls, did a better job of encouraging people to be more active than just giving them the advice leaflet. We found out that the Walking Away programme, when combined with text messages and telephone calls for support, did help participants to take over 500 more steps per day during the first year; however, when we checked again at 4 years, we found that the effects had worn off. Neither option proved to be good value for money.