Enhanced motivational interviewing for reducing weight and increasing physical activity in adults with high cardiovascular risk: the MOVE IT three-arm RCT

Abstract

Background Motivational interviewing (MI) enhanced with behaviour change techniques (BCTs) and deployed by health trainers targeting multiple risk factors for cardiovascular disease (CVD) may be more effective than interventions targeting a single risk factor. Objectives The clinical effectiveness and cost-effectiveness of an enhanced lifestyle motivational interviewing intervention for patients at high risk of CVD in group settings versus individual settings and usual care (UC) in reducing weight and increasing physical activity (PA) were tested. Design This was a three-arm, single-blind, parallel randomised controlled trial. Setting A total of 135 general practices across all 12 South London Clinical Commissioning Groups were recruited. Participants A total of 1742 participants aged 40–74 years with a ≥ 20.0% risk of a CVD event in the following 10 years were randomised. Interventions The intervention was designed to integrate MI and cognitive–behavioural therapy (CBT), delivered by trained healthy lifestyle facilitators in 10 sessions over 1 year, in group or individual format. The control group received UC. Randomisation Simple randomisation was used with computer-generated randomisation blocks. In each block, 10 participants were randomised to the group, individual or UC arm in a 4 : 3 : 3 ratio. Researchers were blind to the allocation. Main outcome measures The primary outcomes are change in weight (kg) from baseline and change in PA (average number of steps per day over 1 week) from baseline at the 24-month follow-up, with an interim follow-up at 12 months. An economic evaluation estimates the relative cost-effectiveness of each intervention. Secondary outcomes include changes in low-density lipoprotein cholesterol and CVD risk score. Results The mean age of participants was 69.75 years (standard deviation 4.11 years), 85.5% were male and 89.4% were white. At the 24-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA [mean 70.05 steps, 95% confidence interval (CI) –288 to 147.9 steps, and mean 7.24 steps, 95% CI –224.01 to 238.5 steps, respectively] or in reducing weight (mean –0.03 kg, 95% CI –0.49 to 0.44 kg, and mean –0.42 kg, 95% CI –0.93 to 0.09 kg, respectively). At the 12-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA (mean 131.1 steps, 95% CI –85.28 to 347.48 steps, and mean 210.22 steps, 95% CI –19.46 to 439.91 steps, respectively), but there were reductions in weight for the group and individual intervention arms compared with UC (mean –0.52 kg, 95% CI –0.90 to –0.13 kg, and mean –0.55 kg, 95% CI –0.95 to –0.14 kg, respectively). The group intervention arm was not more effective than the individual intervention arm in improving outcomes at either follow-up point. The group and individual interventions were not cost-effective. Conclusions Enhanced MI, in group or individual formats, targeted at members of the general population with high CVD risk is not effective in reducing weight or increasing PA compared with UC. Future work should focus on ensuring objective evidence of high competency in BCTs, identifying those with modifiable factors for CVD risk and improving engagement of patients and primary care. Trial registration Current Controlled Trials ISRCTN84864870. 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. 23, No. 69. See the NIHR Journals Library website for further project information. This research was part-funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London.

The effects of step-count monitoring interventions on physical activity: systematic review and meta-analysis of community-based randomised controlled trials in adults

“…Loss to follow-up at 24 months was also significantly higher in the intervention groups than the usual care group [36]. The authors speculated that study fatigue might explain this lack of engagement; interventions involved 10 sessions as well as considerable data collection at baseline 12 and 24 months [36]. This analysis of an unsuccessful complex intervention further strengthens our key conclusion that simple step-count monitoring interventions need to be prioritised.…”

“…At the 2-year time-point, the estimated treatment effect is not statistically significant; this is mainly due to the Ismail et al study, which has a weighting of 65.9% within this follow-up period [36]. This study was not effective at increasing step-counts at either the 1 year or 2-year follow-up points, for which the authors offer several explanations [36]. There was a lack of engagement with the intervention with a delay between randomisation and intervention commencement [36].…”

“…This study was not effective at increasing step-counts at either the 1 year or 2-year follow-up points, for which the authors offer several explanations [36]. There was a lack of engagement with the intervention with a delay between randomisation and intervention commencement [36]. Of participants randomised to the two interventions, 28% did not start the intervention, while an additional 17% did not complete it [36].…”

“…There was a lack of engagement with the intervention with a delay between randomisation and intervention commencement [36]. Of participants randomised to the two interventions, 28% did not start the intervention, while an additional 17% did not complete it [36]. Loss to follow-up at 24 months was also significantly higher in the intervention groups than the usual care group [36].…”

“…Of participants randomised to the two interventions, 28% did not start the intervention, while an additional 17% did not complete it [36]. Loss to follow-up at 24 months was also significantly higher in the intervention groups than the usual care group [36]. The authors speculated that study fatigue might explain this lack of engagement; interventions involved 10 sessions as well as considerable data collection at baseline 12 and 24 months [36].…”