Healthy food prescription incentive programme for adults with type 2 diabetes who are experiencing food insecurity: protocol for a randomised controlled trial, modelling and implementation studies
Introduction The high cost of many healthy foods poses a challenge to maintaining optimal blood glucose levels for adults with type 2 diabetes mellitus who are experiencing food insecurity, leading to diabetes complications and excess acute care usage and costs. Healthy food prescription programmes...
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BMJ Publishing Group
2022-02-01
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| author | Colleen Norris Tyler Williamson Richard Oster Dana Lee Olstad Laura White David J T Campbell Sharlette Dunn Kim D Raine Mary L'Abbé Richard Lewanczuk Lorraine L Lipscombe Eldon Spackman Reed Beall Kienan Williams Sara Scott Gabrielle L Zimmermann Kerry A McBrien Kieran J D Steer Catherine B Chan Sheila Tyminski Seth Berkowitz Alun L Edwards Terry Saunders-Smith Saania Tariq Naomi Popeski Sara Nejatinamini Aruba Naser Carlota Basualdo-Hammond Petra O’Connell Judy Seidel Jason Cabaj |
| author_facet | Colleen Norris Tyler Williamson Richard Oster Dana Lee Olstad Laura White David J T Campbell Sharlette Dunn Kim D Raine Mary L'Abbé Richard Lewanczuk Lorraine L Lipscombe Eldon Spackman Reed Beall Kienan Williams Sara Scott Gabrielle L Zimmermann Kerry A McBrien Kieran J D Steer Catherine B Chan Sheila Tyminski Seth Berkowitz Alun L Edwards Terry Saunders-Smith Saania Tariq Naomi Popeski Sara Nejatinamini Aruba Naser Carlota Basualdo-Hammond Petra O’Connell Judy Seidel Jason Cabaj |
| author_sort | Colleen Norris |
| collection | DOAJ |
| description | Introduction The high cost of many healthy foods poses a challenge to maintaining optimal blood glucose levels for adults with type 2 diabetes mellitus who are experiencing food insecurity, leading to diabetes complications and excess acute care usage and costs. Healthy food prescription programmes may reduce food insecurity and support patients to improve their diet quality, prevent diabetes complications and avoid acute care use. We will use a type 2 hybrid-effectiveness design to examine the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of a healthy food prescription incentive programme for adults experiencing food insecurity and persistent hyperglycaemia. A randomised controlled trial (RCT) will investigate programme effectiveness via impact on glycosylated haemoglobin (primary outcome), food insecurity, diet quality and other clinical and patient-reported outcomes. A modelling study will estimate longer-term programme effectiveness in reducing diabetes-related complications, resource use and costs. An implementation study will examine all RE-AIM domains to understand determinants of effective implementation and reasons behind programme successes and failures.Methods and analysis 594 adults who are experiencing food insecurity and persistent hyperglycaemia will be randomised to a healthy food prescription incentive (n=297) or a healthy food prescription comparison group (n=297). Both groups will receive a healthy food prescription. The incentive group will additionally receive a weekly incentive (CDN$10.50/household member) to purchase healthy foods in supermarkets for 6 months. Outcomes will be assessed at baseline and follow-up (6 months) in the RCT and analysed using mixed-effects regression. Longer-term outcomes will be modelled using the UK Prospective Diabetes Study outcomes simulation model-2. Implementation processes and outcomes will be continuously measured via quantitative and qualitative data.Ethics and dissemination Ethical approval was obtained from the University of Calgary and the University of Alberta. Findings will be disseminated through reports, lay summaries, policy briefs, academic publications and conference presentations.Trial registration number NCT04725630.Protocol version Version 1.1; February 2022 |
| format | Article |
| id | doaj-art-bb33efea8211470291f00a819e294a74 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-02-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-bb33efea8211470291f00a819e294a742025-02-07T00:40:09ZengBMJ Publishing GroupBMJ Open2044-60552022-02-0112210.1136/bmjopen-2021-050006Healthy food prescription incentive programme for adults with type 2 diabetes who are experiencing food insecurity: protocol for a randomised controlled trial, modelling and implementation studiesColleen Norris0Tyler Williamson1Richard Oster2Dana Lee Olstad3Laura White4David J T Campbell5Sharlette Dunn6Kim D Raine7Mary L'Abbé8Richard Lewanczuk9Lorraine L Lipscombe10Eldon Spackman11Reed Beall12Kienan Williams13Sara Scott14Gabrielle L Zimmermann15Kerry A McBrien16Kieran J D Steer17Catherine B Chan18Sheila Tyminski19Seth Berkowitz20Alun L Edwards21Terry Saunders-Smith22Saania Tariq23Naomi Popeski24Sara Nejatinamini25Aruba Naser26Carlota Basualdo-Hammond27Petra O’Connell28Judy Seidel29Jason Cabaj306 Faculty of Nursing, University of Alberta, Edmonton, Alberta, CanadaCumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaDepartment of Agricultural, Food & Nutritional Sciences, University of Alberta, Edmonton, Alberta, CanadaDepartment of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaCR UK & UCL Cancer Trials Centre, University College London, London, UKMedicine, University of Calgary, Calgary, Alberta, CanadaDepartment of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaSchool of Public Health, University of Alberta, 3-300 Edmonton Clinic Health Academy, Edmonton, Alberta, CanadaDepartment of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, CanadaDepartment of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Calgary, Alberta, CanadaWomen`s College Research Institute, Women’s College Hospital, Toronto, Ontario, CanadaDepartment of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaDepartment of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaAlberta Health Services, Calgary, Alberta, CanadaCommunity Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaDepartment of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaDepartment of Family Medicine, G012 Health Sciences Centre, 3330 Hospital Drive NW, Calgary, Alberta, CanadaDepartment of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaDepartment of Agricultural, Food & Nutritional Sciences, University of Alberta, Edmonton, Alberta, CanadaNutrition Services, Alberta Health Services, Edmonton, Alberta, CanadaDivision of General Medicine and Clinical Epidemiology, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Gatineau, Quebec, CanadaDepartment of Medicine, Cumming School of Medicine, University of Calgary Foothills Medical Centre, Calgary, Alberta, CanadaDepartment of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaDepartment of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaDepartment of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaDepartment of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaDepartment of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaNutrition Services, Alberta Health Services, Edmonton, Alberta, CanadaDiabetes, Obesity and Nutrition Strategic Clinical Network, Alberta Health Services, Calgary, Alberta, CanadaDepartment of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaDepartment of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, CanadaIntroduction The high cost of many healthy foods poses a challenge to maintaining optimal blood glucose levels for adults with type 2 diabetes mellitus who are experiencing food insecurity, leading to diabetes complications and excess acute care usage and costs. Healthy food prescription programmes may reduce food insecurity and support patients to improve their diet quality, prevent diabetes complications and avoid acute care use. We will use a type 2 hybrid-effectiveness design to examine the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of a healthy food prescription incentive programme for adults experiencing food insecurity and persistent hyperglycaemia. A randomised controlled trial (RCT) will investigate programme effectiveness via impact on glycosylated haemoglobin (primary outcome), food insecurity, diet quality and other clinical and patient-reported outcomes. A modelling study will estimate longer-term programme effectiveness in reducing diabetes-related complications, resource use and costs. An implementation study will examine all RE-AIM domains to understand determinants of effective implementation and reasons behind programme successes and failures.Methods and analysis 594 adults who are experiencing food insecurity and persistent hyperglycaemia will be randomised to a healthy food prescription incentive (n=297) or a healthy food prescription comparison group (n=297). Both groups will receive a healthy food prescription. The incentive group will additionally receive a weekly incentive (CDN$10.50/household member) to purchase healthy foods in supermarkets for 6 months. Outcomes will be assessed at baseline and follow-up (6 months) in the RCT and analysed using mixed-effects regression. Longer-term outcomes will be modelled using the UK Prospective Diabetes Study outcomes simulation model-2. Implementation processes and outcomes will be continuously measured via quantitative and qualitative data.Ethics and dissemination Ethical approval was obtained from the University of Calgary and the University of Alberta. Findings will be disseminated through reports, lay summaries, policy briefs, academic publications and conference presentations.Trial registration number NCT04725630.Protocol version Version 1.1; February 2022https://bmjopen.bmj.com/content/12/2/e050006.full |
| spellingShingle | Colleen Norris Tyler Williamson Richard Oster Dana Lee Olstad Laura White David J T Campbell Sharlette Dunn Kim D Raine Mary L'Abbé Richard Lewanczuk Lorraine L Lipscombe Eldon Spackman Reed Beall Kienan Williams Sara Scott Gabrielle L Zimmermann Kerry A McBrien Kieran J D Steer Catherine B Chan Sheila Tyminski Seth Berkowitz Alun L Edwards Terry Saunders-Smith Saania Tariq Naomi Popeski Sara Nejatinamini Aruba Naser Carlota Basualdo-Hammond Petra O’Connell Judy Seidel Jason Cabaj Healthy food prescription incentive programme for adults with type 2 diabetes who are experiencing food insecurity: protocol for a randomised controlled trial, modelling and implementation studies BMJ Open |
| title | Healthy food prescription incentive programme for adults with type 2 diabetes who are experiencing food insecurity: protocol for a randomised controlled trial, modelling and implementation studies |
| title_full | Healthy food prescription incentive programme for adults with type 2 diabetes who are experiencing food insecurity: protocol for a randomised controlled trial, modelling and implementation studies |
| title_fullStr | Healthy food prescription incentive programme for adults with type 2 diabetes who are experiencing food insecurity: protocol for a randomised controlled trial, modelling and implementation studies |
| title_full_unstemmed | Healthy food prescription incentive programme for adults with type 2 diabetes who are experiencing food insecurity: protocol for a randomised controlled trial, modelling and implementation studies |
| title_short | Healthy food prescription incentive programme for adults with type 2 diabetes who are experiencing food insecurity: protocol for a randomised controlled trial, modelling and implementation studies |
| title_sort | healthy food prescription incentive programme for adults with type 2 diabetes who are experiencing food insecurity protocol for a randomised controlled trial modelling and implementation studies |
| url | https://bmjopen.bmj.com/content/12/2/e050006.full |
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