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

Author:

Khunti Kamlesh12ORCID,Griffin Simon34ORCID,Brennan Alan5ORCID,Dallosso Helen26ORCID,Davies Melanie17ORCID,Eborall Helen8ORCID,Edwardson Charlotte17ORCID,Gray Laura9ORCID,Hardeman Wendy10ORCID,Heathcote Laura5ORCID,Henson Joseph17ORCID,Morton Katie111213ORCID,Pollard Daniel5ORCID,Sharp Stephen3ORCID,Sutton Stephen11ORCID,Troughton Jacqui6ORCID,Yates Thomas17ORCID

Affiliation:

1. Diabetes Research Centre, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, UK

2. NIHR Applied Research Collaboration, East Midlands, UK

3. MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge, UK

4. Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK

5. School of Health and Related Research, University of Sheffield, Sheffield, UK

6. Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK

7. NIHR Leicester Biomedical Research Centre, Leicester, UK

8. Social Science Applied to Healthcare Improvement Research Group, Department of Health Sciences, University of Leicester, Leicester, UK

9. Biostatistics Research Group, Department of Health Sciences, University of Leicester, Leicester, UK

10. School of Health Sciences, University of East Anglia, Norwich, UK

11. Behavioural Science Group, Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK

12. UKCRC Centre for Diet and Activity Research (CEDAR), MRC Epidemiology Unit, University of Cambridge, Cambridge, UK

13. Innovia Technology Limited, Cambridge, UK

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 [HbA1c ≥ 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/m2, 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.

Funder

Health Technology Assessment programme

Publisher

National Institute for Health Research

Subject

Health Policy

Reference151 articles.

1. PRomotion Of Physical activity through structured Education with differing Levels of ongoing Support for people at high risk of type 2 diabetes (PROPELS): study protocol for a randomized controlled trial;Yates;Trials,2015

2. IDF Diabetes Atlas. 5th edn. Brussels: International Diabetes Federation, Executive Office; 2011.

3. Life years lost and lifetime health care expenditures associated with diabetes in the United States;Leung;Value Health,2014

4. Estimating the current and future costs of Type 1 and Type 2 diabetes in the UK, including direct health costs and indirect societal and productivity costs;Hex;Diabet Med,2012

5. World Health Organization. Definition and Diagnosis of Diabetes Mellitus and Intermediate Hyperglycaemia: Report of a WHO/IDF Consultation. Geneva: World Health Organization; 2006.

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