Evidence map›Paper›PMID 39533314›Full record

ArticleTrials2024

Effectiveness of a digital health and financial incentive intervention to promote physical activity in patients with type 2 diabetes: study protocol for a randomised controlled trial with a nested qualitative study-ACTIVATE trial.

James P Sanders, Amanda J Daley, Dale W Esliger, Andrea K Roalfe, Antoanela Colda, Joanne Turner, Soma Hajdu, Andrew Potter, Asif M Humayun, Ioannis Spiliotis and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

James P SandersCentre for Lifestyle Medicine and Behaviour, Loughborough University, Loughborough, UK. J.Sanders2@lboro.ac.uk.ORCID http://orcid.org/0000-0003-2103-0631
Amanda J DaleyCentre for Lifestyle Medicine and Behaviour, Loughborough University, Loughborough, UK.
Dale W EsligerCentre for Lifestyle Medicine and Behaviour, Loughborough University, Loughborough, UK.
Andrea K RoalfeCentre for Lifestyle Medicine and Behaviour, Loughborough University, Loughborough, UK.
Antoanela ColdaResearch and Development, Milton Keynes University Hospital, Milton Keynes, UK.
Joanne TurnerResearch and Development, Milton Keynes University Hospital, Milton Keynes, UK.
Soma HajduResearch and Development, Milton Keynes University Hospital, Milton Keynes, UK.
Andrew PotterWhaddon Medical Centre, Milton Keynes, UK.
Asif M HumayunMilton Keynes University Hospital NHS Foundation Trust, Milton Keynes, UK.
Ioannis SpiliotisMilton Keynes University Hospital NHS Foundation Trust, Milton Keynes, UK.
Ian RecklessMilton Keynes University Hospital NHS Foundation Trust, Milton Keynes, UK.
Oliver MyttonMilton Keynes University Hospital NHS Foundation Trust, Milton Keynes, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe prevention of type 2 diabetes (T2DM) is recognised as a health care priority in the UK. In people living with T2DM, lifestyle changes (e.g. increasing physical activity) have been shown to slow disease progression and protect from the development of associated comorbidities. The use of digital health technologies provides a strategy to increase physical activity in patients with chronic disease. Furthermore, behaviour economics suggests that financial incentives may be a useful strategy for increasing the maintenance and effectiveness of behaviour change intervention, including physical activity intervention using digital health technologies. The Milton Keynes Activity Rewards Programme (MKARP) is a 24-month intervention which combines the use of a mobile health app, smartwatch (Fitbit or Apple watch) and financial incentives to encourage people living with T2DM to increase physical activity to improve health. Therefore, this randomised controlled trial aims to examine the long-term acceptability, health effects and cost-effectiveness of the MKARP on HbA1c in patients living with T2DM versus a waitlist usual care comparator.

methodsA two-arm, single-centre, randomised controlled trial aiming to recruit 1018 participants with follow-up at 12 and 24 months. The primary outcome is the change in HbA1c at 12 months. Secondary outcomes included changes in markers of metabolic, cardiovascular, anthropometric, and psychological health along with cost-effectiveness. Recruitment will be via annual diabetes review in general practices, retinal screening services and social media. Participants aged 18 or over, with a diagnosis of type 2 diabetes and a valid HbA1c measurement in the last 2 months are invited to take part in the trial. Participants will be individually randomised (1:1 ratio) to receive either the Milton Keynes Activity Rewards Programme or usual care. The intervention will last for 24 months with assessment for outcomes at baseline, 12 and 24 months. DISCUSSION: This study will provide new evidence of the long-term effectiveness of an activity rewards scheme focused on increasing physical activity conducted within routine care in patients living with type 2 diabetes in Milton Keynes, UK. It will also investigate the cost-effectiveness of the intervention.

trial registrationISRCTN 14925701. Registered on 30 October 2023.

Indexed as

Cost-Benefit AnalysisDiabetes Mellitus, Type 2ExerciseMobile ApplicationsMotivationRandomized Controlled Trials as TopicDigital HealthFemaleFitness TrackersGlycated HemoglobinHumansMaleMiddle AgedQualitative ResearchTelemedicineTime FactorsGlycated Hemoglobinhemoglobin A1c protein, humanDigital healthFinancial incentivesmHealthPhysical activityRoutine careType 2 diabetes

Identifiers

PMID39533314
PMCPMC11559103

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.