A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults with severe obesity: a feasibility randomised controlled trial protocol
dc.contributor.author | Swancutt, D | |
dc.contributor.author | Tarrant, M | |
dc.contributor.author | Ingram, W | |
dc.contributor.author | Baldrey, S | |
dc.contributor.author | Burns, L | |
dc.contributor.author | Byng, R | |
dc.contributor.author | Calitri, R | |
dc.contributor.author | Creanor, S | |
dc.contributor.author | Dean, S | |
dc.contributor.author | Evans, L | |
dc.contributor.author | Gill, L | |
dc.contributor.author | Goodwin, E | |
dc.contributor.author | Hawkins, L | |
dc.contributor.author | Hayward, C | |
dc.contributor.author | Hind, S | |
dc.contributor.author | Hollands, L | |
dc.contributor.author | Hosking, J | |
dc.contributor.author | Lloyd, J | |
dc.contributor.author | Moghadam, S | |
dc.contributor.author | Neilens, H | |
dc.contributor.author | O’Kane, M | |
dc.contributor.author | Perry, S | |
dc.contributor.author | Sheaff, R | |
dc.contributor.author | Spencer, A | |
dc.contributor.author | Taylor, A | |
dc.contributor.author | Ward, T | |
dc.contributor.author | Watkins, R | |
dc.contributor.author | Wilding, J | |
dc.contributor.author | Pinkney, J | |
dc.date.accessioned | 2022-11-02T09:58:02Z | |
dc.date.issued | 2022-09-10 | |
dc.identifier.issn | 2055-5784 | |
dc.identifier.issn | 2055-5784 | |
dc.identifier.other | 206 | |
dc.identifier.uri | http://hdl.handle.net/10026.1/19819 | |
dc.description.abstract |
<jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>Approximately 15 million people in the UK live with obesity, around 5 million of whom have severe obesity (body mass index (BMI) ≥35kg/m<jats:sup>2</jats:sup>). Having severe obesity markedly compromises health, well-being and quality of life, and substantially reduces life expectancy. These adverse outcomes are prevented or ameliorated by weight loss, for which sustained behavioural change is the cornerstone of treatment. Although NHS specialist ‘Tier 3’ Weight Management Services (T3WMS) support people with severe obesity, using individual and group-based treatment, the current evidence on optimal intervention design and outcomes is limited. Due to heterogeneity of severe obesity, there is a need to tailor treatment to address individual needs. Despite this heterogeneity, there are good reasons to suspect that a structured group-based behavioural intervention may be more effective and cost-effective for the treatment of severe obesity compared to usual care. The aims of this study are to test the feasibility of establishing and delivering a multi-centre randomised controlled clinical trial to compare a group-based behavioural intervention versus usual care in people with severe obesity.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>This feasibility randomised controlled study is a partially clustered multi-centre trial of PROGROUP (a novel group-based behavioural intervention) versus usual care. Adults ≥18 years of age who have been newly referred to and accepted by NHS T3WMS will be eligible if they have a BMI ≥40, or ≥35 kg/m<jats:sup>2</jats:sup> with comorbidity, are suitable for group-based care and are willing to be randomised. Exclusion criteria are participation in another weight management study, planned bariatric surgery during the trial, and unwillingness or inability to attend group sessions. Outcome assessors will be blinded to treatment allocation and success of blinding will be evaluated. Clinical measures will be collected at baseline, 6 and 12 months post-randomisation. Secondary outcome measures will be self-reported and collected remotely. Process and economic evaluations will be conducted.</jats:p> </jats:sec><jats:sec> <jats:title>Discussion</jats:title> <jats:p>This randomised feasibility study has been designed to test all the required research procedures and additionally explore three key issues; the feasibility of implementing a complex trial at participating NHS T3WMS, training the multidisciplinary healthcare teams in a standard intervention, and the acceptability of a group intervention for these particularly complex patients.</jats:p> </jats:sec><jats:sec> <jats:title>Trial registration</jats:title> <jats:p>ISRCTN number 22088800.</jats:p> </jats:sec> | |
dc.format.extent | 206- | |
dc.format.medium | Electronic | |
dc.language | en | |
dc.language.iso | eng | |
dc.publisher | BioMed Central | |
dc.subject | Severe obesity | |
dc.subject | Weight management | |
dc.subject | Group-based | |
dc.subject | Feasibility | |
dc.subject | Behavioural intervention | |
dc.title | A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults with severe obesity: a feasibility randomised controlled trial protocol | |
dc.type | journal-article | |
dc.type | Article | |
plymouth.author-url | https://www.ncbi.nlm.nih.gov/pubmed/36088457 | |
plymouth.issue | 1 | |
plymouth.volume | 8 | |
plymouth.publication-status | Published online | |
plymouth.journal | Pilot and Feasibility Studies | |
dc.identifier.doi | 10.1186/s40814-022-01167-0 | |
plymouth.organisational-group | /Plymouth | |
plymouth.organisational-group | /Plymouth/Faculty of Health | |
plymouth.organisational-group | /Plymouth/Faculty of Health/Peninsula Dental School | |
plymouth.organisational-group | /Plymouth/Faculty of Health/Peninsula Medical School | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA03 Allied Health Professions, Dentistry, Nursing and Pharmacy | |
plymouth.organisational-group | /Plymouth/Research Groups | |
plymouth.organisational-group | /Plymouth/Research Groups/FoH - Community and Primary Care | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Health and Community | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED) | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CBBB | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CCT&PS | |
plymouth.organisational-group | /Plymouth/Research Groups/Plymouth Institute of Health and Care Research (PIHR) | |
plymouth.organisational-group | /Plymouth/Users by role | |
plymouth.organisational-group | /Plymouth/Users by role/Academics | |
dc.publisher.place | England | |
dcterms.dateAccepted | 2022-08-25 | |
dc.rights.embargodate | 2022-11-3 | |
dc.identifier.eissn | 2055-5784 | |
dc.rights.embargoperiod | Not known | |
rioxxterms.funder | National Institute for Health Research | |
rioxxterms.identifier.project | How are treatment outcomes for people with severe obesity ImPROved by GROUP-based behavioural intervention? | |
rioxxterms.versionofrecord | 10.1186/s40814-022-01167-0 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2022-09-10 | |
rioxxterms.type | Journal Article/Review | |
plymouth.funder | How are treatment outcomes for people with severe obesity ImPROved by GROUP-based behavioural intervention?::National Institute for Health Research |