Evidence map›Paper›PMID 33177130›Full record

ArticleBMJ open2020

Implementation, mechanisms of impact and key contextual factors involved in outcomes of the Modification of Diet, Exercise and Lifestyle (MODEL) randomised controlled trial in Australian adults: protocol for a mixed-method process evaluation.

Reindolf Anokye, Simone Radavelli-Bagatini, Catherine P Bondonno, Marc Sim, Lauren C Blekkenhorst, Emma Connolly, Nicola P Bondonno, John T Schousboe, Richard Woodman, Kun Zhu and 15 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Trial
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

25 authors.

Reindolf AnokyeSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia ranokye@our.ecu.edu.au.ORCID 0000-0002-7669-7057
Simone Radavelli-BagatiniSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.ORCID 0000-0001-6821-5217
Catherine P BondonnoSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.
Marc SimSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.ORCID 0000-0001-5166-0605
Lauren C BlekkenhorstSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.
Emma ConnollySchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.
Nicola P BondonnoSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.
John T SchousboePark Nicollet Osteoporosis Center and Health Partners Institute and Division of Health Policy and Management, University of Minnesota, Minneapolis, Minnesota, USA.
Richard WoodmanFlinders Centre for Epidemiology and Biostatistics, Flinders University, Adelaide, South Australia, Australia.
Kun ZhuMedical School, University of Western Australia, Perth, Western Australia, Australia.
Pawel SzulcINSERM UMR1033, University of Lyon, Lyon, France.
Ben JacksonSchool of Human Sciences (Exercise and Sport Science), University of Western Australia, Perth, Western Australia, Australia.
James DimmockDepartment of Psychology, College of Healthcare Sciences, James Cook University, Townsville, Queensland, Australia.
Markus P SchlaichMedical School, University of Western Australia, Perth, Western Australia, Australia.
Kay L CoxMedical School, University of Western Australia, Perth, Western Australia, Australia.
Douglas P KielHinda and Arthur Marcus Institute for Aging Research, Hebrew Senior Life, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
Wai H LimMedical School, University of Western Australia, Perth, Western Australia, Australia.
Amanda DevineSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.
Peter L ThompsonDepartment of Cardiology, University of Western Australia, Perth, Western Australia, Australia.
Jenny GianoudisInstitute for Physical Activity and Nutrition, School of Exercise and Nutrition Science, Deakin University, Geelong, Victoria, Australia.
Belinda De RossInstitute for Physical Activity and Nutrition, School of Exercise and Nutrition Science, Deakin University, Geelong, Victoria, Australia.
Robin M DalyInstitute for Physical Activity and Nutrition, School of Exercise and Nutrition Science, Deakin University, Geelong, Victoria, Australia.
Jonathan M HodgsonSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.
Joshua R LewisSchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.
Mandy StanleySchool of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.ORCID 0000-0002-7958-5181

Funding

RISK FACTORS FOR VERTEBRAL FRACTURE AND BONE LOSSR01AR041398 · NIAMS · RHODE ISLAND HOSPITAL (PROVIDENCE, RI) · PI KIEL, DOUGLAS P. · 1991 to 2025
$16.1M
NIAMS NIH HHS R01 AR041398
6 · The paper itself

Abstract

introductionThe Modification of Diet, Exercise and Lifestyle (MODEL) study aims to examine the impact of providing visualisation and pictorial representation of advanced structural vascular disease (abdominal aortic calcification), on 'healthful' improvements to diet and lifestyle. This paper reports the protocol for the process evaluation for the MODEL study. METHODS AND ANALYSIS: The overall aim of the process evaluation is to understand the processes that took place during participation in the MODEL study trial and which elements were effective or ineffective for influencing 'healthful' behavioural change, and possible ways of improvement to inform wider implementation strategies. A mixed-method approach will be employed with the use of structured questionnaires and semistructured in-depth interviews. All 200 participants enrolled in the trial will undertake the quantitative component of the study and maximum variation sampling will be used to select a subsample for the qualitative component. The sample size for the qualitative component will be determined based on analytical saturation. Interviews will be digitally recorded and transcribed verbatim. Qualitative data will be analysed thematically and reported according to the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines. ETHICS AND DISSEMINATION: The MODEL study process evaluation has received approval from Edith Cowan University Human Research Ethics Committee (Project Number: 20513 HODGSON). Written informed consent will be obtained from all participants before they are included in the study. The study results will be shared with the individuals and institutions associated with this study as well as academic audiences through peer-reviewed publication and probable presentation at conferences. TRIAL REGISTRATION NUMBER: ACTRN12618001087246.

Indexed as

Life StyleResearch DesignAdultAustraliaDietHumansQualitative ResearchRandomized Controlled Trials as Topicmedical ethicspublic healthqualitative researchsocial medicinestatistics & research methods

Identifiers

PMID33177130
PMCPMC7661373

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.