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Headline
Enhanced motivational interviewing, in group or individual formats, did not reduce weight or increase physical activity in adults with high cardiovascular disease risk.
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.
Contents
- Plain English summary
- Scientific summary
- Chapter 1. Introduction
- Epidemiology of cardiovascular disease and its risk factors
- Cardiovascular risk identification
- The evidence for increasing physical activity
- The evidence for dietary interventions
- The evidence for motivational interviewing
- A taxonomy of behaviour change techniques
- The role of health trainers
- The case for an enhanced motivational interviewing intervention
- Chapter 2. Research objectives
- Chapter 3. Methods
- Chapter 4. Protocol changes
- Chapter 5. Main clinical results of the trial
- Practice recruitment
- Participant recruitment and flow through the trial
- Intervention delivery
- Loss to follow-up
- Accelerometer data completeness
- Baseline characteristics
- Missing data
- Primary outcomes
- Assessment of assumptions
- Assessment of standard deviations between arms and over time
- Weight
- Assessment of assumptions
- Assessment of standard deviations between arms and over time
- Sensitivity analyses
- Secondary outcomes
- Chapter 6. Cost-effectiveness
- Chapter 7. Participation biases
- Chapter 8. Fidelity analysis
- Chapter 9. Qualitative findings: the views of participants
- Chapter 10. Qualitative findings: the views of healthy lifestyle facilitators and clinical psychologists
- Chapter 11. Discussion
- Acknowledgements
- References
- Appendix 1. Proficiency levels adapted for healthy lifestyle facilitator training
- Appendix 2. List of participating general practices
- Appendix 3. Behaviour change technique coding framework for the fidelity analysis
- Appendix 4. Participant focus group topic guides
- Appendix 5. Characteristics of focus group attendees
- Appendix 6. Health-care professional feedback topic guides
- List of abbreviations
- List of supplementary material
About the Series
Article history
The research reported in this issue of the journal was funded by the HTA programme as project number 10/62/03. The contractual start date was in January 2013. The draft report began editorial review in April 2018 and was accepted for publication in September 2018. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.
Declared competing interests of authors
Khalida Ismail has received honoraria for educational lectures from Sanofi SA (Paris, France), Novo Nordisk (Bagsværd, Denmark), Janssen Pharmaceutica (Beerse, Belgium) and Eli Lilly and Company (Indianapolis, IN, USA). Kirsty Winkley received consultancy fees from Merck Sharp & Dohme (Kenilworth, NJ, USA).
Last reviewed: April 2018; Accepted: September 2018.
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