A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults with severe obesity: a feasibility randomised controlled trial protocol
Abstract Background Approximately 15 million people in the UK live with obesity, around 5 million of whom have severe obesity (body mass index (BMI) ≥35kg/m2). Having severe obesity markedly compromises health, well-being and quality of life, and substantially reduces life expectancy. These adverse...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2022-09-01
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| Series: | Pilot and Feasibility Studies |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40814-022-01167-0 |
| _version_ | 1798002953205841920 |
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| author | Dawn Swancutt Mark Tarrant Wendy Ingram Sarah Baldrey Lorna Burns Richard Byng Raff Calitri Siobhan Creanor Sarah Dean Lucy Evans Laura Gill Elizabeth Goodwin Lily Hawkins Chris Hayward Sarah Hind Laura Hollands Joanne Hosking Jenny Lloyd Shokraneh Moghadam Helen Neilens Mary O’Kane Steve Perry Rod Sheaff Anne Spencer Adrian Taylor Thomas Ward Ross Watkins John Wilding Jonathan Pinkney |
| author_facet | Dawn Swancutt Mark Tarrant Wendy Ingram Sarah Baldrey Lorna Burns Richard Byng Raff Calitri Siobhan Creanor Sarah Dean Lucy Evans Laura Gill Elizabeth Goodwin Lily Hawkins Chris Hayward Sarah Hind Laura Hollands Joanne Hosking Jenny Lloyd Shokraneh Moghadam Helen Neilens Mary O’Kane Steve Perry Rod Sheaff Anne Spencer Adrian Taylor Thomas Ward Ross Watkins John Wilding Jonathan Pinkney |
| author_sort | Dawn Swancutt |
| collection | DOAJ |
| description | Abstract Background Approximately 15 million people in the UK live with obesity, around 5 million of whom have severe obesity (body mass index (BMI) ≥35kg/m2). 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. Methods 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/m2 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. Discussion 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. Trial registration ISRCTN number 22088800. |
| first_indexed | 2024-04-11T12:00:31Z |
| format | Article |
| id | doaj.art-2115fd3ec57e4c4485e3d760230ffe5f |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-04-11T12:00:31Z |
| publishDate | 2022-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-2115fd3ec57e4c4485e3d760230ffe5f2022-12-22T04:24:51ZengBMCPilot and Feasibility Studies2055-57842022-09-018111310.1186/s40814-022-01167-0A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults with severe obesity: a feasibility randomised controlled trial protocolDawn Swancutt0Mark Tarrant1Wendy Ingram2Sarah Baldrey3Lorna Burns4Richard Byng5Raff Calitri6Siobhan Creanor7Sarah Dean8Lucy Evans9Laura Gill10Elizabeth Goodwin11Lily Hawkins12Chris Hayward13Sarah Hind14Laura Hollands15Joanne Hosking16Jenny Lloyd17Shokraneh Moghadam18Helen Neilens19Mary O’Kane20Steve Perry21Rod Sheaff22Anne Spencer23Adrian Taylor24Thomas Ward25Ross Watkins26John Wilding27Jonathan Pinkney28University of Plymouth, Faculty of Health, University of PlymouthUniversity of Exeter, College of Medicine and Health, St Luke’s CampusUniversity of Plymouth, Faculty of Health, University of PlymouthLivewell South West, Cumberland Centre, Damerel CloseUniversity of Plymouth, Faculty of Health, University of PlymouthUniversity of Plymouth, Faculty of Health, University of PlymouthUniversity of Exeter, College of Medicine and Health, St Luke’s CampusUniversity of Exeter, College of Medicine and Health, St Luke’s CampusUniversity of Exeter, College of Medicine and Health, St Luke’s CampusUniversity of Exeter, College of Medicine and Health, St Luke’s CampusUniversity of Plymouth, Faculty of Health, University of PlymouthUniversity of Exeter, College of Medicine and Health, St Luke’s CampusUniversity of Exeter, College of Medicine and Health, St Luke’s CampusUniversity of Plymouth, Faculty of Health, University of PlymouthLivewell South West, Cumberland Centre, Damerel CloseUniversity of Exeter, College of Medicine and Health, St Luke’s CampusUniversity of Plymouth, Faculty of Health, University of PlymouthUniversity of Exeter, College of Medicine and Health, St Luke’s CampusUniversity of Exeter, College of Medicine and Health, St Luke’s CampusUniversity Hospitals Plymouth NHS TrustLeeds Teaching Hospital NHS Trust, St James’s University HospitalIndependent ConsultantUniversity of Plymouth, Faculty of Health, University of PlymouthUniversity of Exeter, College of Medicine and Health, St Luke’s CampusUniversity of Plymouth, Faculty of Health, University of PlymouthUniversity of Exeter, College of Medicine and Health, St Luke’s CampusUniversity of Exeter, College of Medicine and Health, St Luke’s CampusUniversity of Liverpool, Department of Cardiovascular and Metabolic Medicine, Clinical Sciences Centre, Aintree University HospitalUniversity of Plymouth, Faculty of Health, University of PlymouthAbstract Background Approximately 15 million people in the UK live with obesity, around 5 million of whom have severe obesity (body mass index (BMI) ≥35kg/m2). 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. Methods 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/m2 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. Discussion 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. Trial registration ISRCTN number 22088800.https://doi.org/10.1186/s40814-022-01167-0Severe obesityWeight managementGroup-basedFeasibilityBehavioural intervention |
| spellingShingle | Dawn Swancutt Mark Tarrant Wendy Ingram Sarah Baldrey Lorna Burns Richard Byng Raff Calitri Siobhan Creanor Sarah Dean Lucy Evans Laura Gill Elizabeth Goodwin Lily Hawkins Chris Hayward Sarah Hind Laura Hollands Joanne Hosking Jenny Lloyd Shokraneh Moghadam Helen Neilens Mary O’Kane Steve Perry Rod Sheaff Anne Spencer Adrian Taylor Thomas Ward Ross Watkins John Wilding Jonathan Pinkney A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults with severe obesity: a feasibility randomised controlled trial protocol Pilot and Feasibility Studies Severe obesity Weight management Group-based Feasibility Behavioural intervention |
| title | A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults with severe obesity: a feasibility randomised controlled trial protocol |
| title_full | A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults with severe obesity: a feasibility randomised controlled trial protocol |
| title_fullStr | A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults with severe obesity: a feasibility randomised controlled trial protocol |
| title_full_unstemmed | A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults with severe obesity: a feasibility randomised controlled trial protocol |
| title_short | A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults with severe obesity: a feasibility randomised controlled trial protocol |
| title_sort | group based behavioural intervention for weight management progroup versus usual care in adults with severe obesity a feasibility randomised controlled trial protocol |
| topic | Severe obesity Weight management Group-based Feasibility Behavioural intervention |
| url | https://doi.org/10.1186/s40814-022-01167-0 |
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