Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND): protocol for a randomised feasibility trial
<p>Introduction: Some clinicians have observed that low-carbohydrate, low-energy diets can improve blood glucose control, with reports of remission from type 2 diabetes in some patients. In clinical trials, support for low-carbohydrate, low-energy diets has been provided by specialist staff an...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Journal article |
| Published: |
BMJ Publishing Group
2019
|
| _version_ | 1797101256949366784 |
|---|---|
| author | Morris, E Aveyard, P Dyson, P Noreik, M Bailey, C Fox, R Hoffman, K Tan, G Jebb, S |
| author_facet | Morris, E Aveyard, P Dyson, P Noreik, M Bailey, C Fox, R Hoffman, K Tan, G Jebb, S |
| author_sort | Morris, E |
| collection | OXFORD |
| description | <p>Introduction: Some clinicians have observed that low-carbohydrate, low-energy diets can improve blood glucose control, with reports of remission from type 2 diabetes in some patients. In clinical trials, support for low-carbohydrate, low-energy diets has been provided by specialist staff and these programmes are unsuitable for widespread deployment in routine primary care. The aim of this trial is to test whether a newly developed behavioural support programme can effectively deliver a low-energy, low-carbohydrate diet in a primary care setting.</p><p> Methods and analysis: This is a feasibility randomised controlled trial (RCT) with embedded qualitative study. Thirty adult patients with type 2 diabetes and body mass index ≥30 kg/m2 in 2–4 general practices will be randomised 2:1 intervention or control and followed up over 12 weeks. The intervention diet comprises 8 weeks of a low-carbohydrate food-based diet providing around 800 kcal/day, followed by 4 weeks of weight maintenance. This programme will be delivered by practice nurses, who will also support patients through goal-setting, motivation and self-monitoring across four appointments, and provide a self-help booklet with recipes, shopping lists and other behavioural support. Primary outcome measures of feasibility will be met if CIs do not cross the following proportions: that 60% of intervention group participants attempt the dietary intervention, healthcare professionals conduct the intervention delivery session with at least 60% of essential elements present and 60% of participants attend the final follow-up session. Secondary outcome measures will assess process and qualitative measures, as well as exploratory outcomes including change in haemoglobin A1c and change in weight.</p><p> This study has been granted ethical approval by the National Research Ethics Service, South Central Oxford B Research Ethics Committee (ref: 18/SC/0071). The study results will inform whether to progress to a full-scale RCT to test the efficacy of offering this programme for patients with type 2 diabetes in primary care.</p><p> TRIAL REGISTRATION NUMBER: ISRCTN registry (ISRCTN 62452621)</p> |
| first_indexed | 2024-03-07T05:49:15Z |
| format | Journal article |
| id | oxford-uuid:e84c010d-f92b-4ef7-9124-7581dace345f |
| institution | University of Oxford |
| last_indexed | 2024-03-07T05:49:15Z |
| publishDate | 2019 |
| publisher | BMJ Publishing Group |
| record_format | dspace |
| spelling | oxford-uuid:e84c010d-f92b-4ef7-9124-7581dace345f2022-03-27T10:45:36ZDietary Approaches to the Management Of type 2 Diabetes (DIAMOND): protocol for a randomised feasibility trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:e84c010d-f92b-4ef7-9124-7581dace345fSymplectic Elements at OxfordBMJ Publishing Group2019Morris, EAveyard, PDyson, PNoreik, MBailey, CFox, RHoffman, KTan, GJebb, S<p>Introduction: Some clinicians have observed that low-carbohydrate, low-energy diets can improve blood glucose control, with reports of remission from type 2 diabetes in some patients. In clinical trials, support for low-carbohydrate, low-energy diets has been provided by specialist staff and these programmes are unsuitable for widespread deployment in routine primary care. The aim of this trial is to test whether a newly developed behavioural support programme can effectively deliver a low-energy, low-carbohydrate diet in a primary care setting.</p><p> Methods and analysis: This is a feasibility randomised controlled trial (RCT) with embedded qualitative study. Thirty adult patients with type 2 diabetes and body mass index ≥30 kg/m2 in 2–4 general practices will be randomised 2:1 intervention or control and followed up over 12 weeks. The intervention diet comprises 8 weeks of a low-carbohydrate food-based diet providing around 800 kcal/day, followed by 4 weeks of weight maintenance. This programme will be delivered by practice nurses, who will also support patients through goal-setting, motivation and self-monitoring across four appointments, and provide a self-help booklet with recipes, shopping lists and other behavioural support. Primary outcome measures of feasibility will be met if CIs do not cross the following proportions: that 60% of intervention group participants attempt the dietary intervention, healthcare professionals conduct the intervention delivery session with at least 60% of essential elements present and 60% of participants attend the final follow-up session. Secondary outcome measures will assess process and qualitative measures, as well as exploratory outcomes including change in haemoglobin A1c and change in weight.</p><p> This study has been granted ethical approval by the National Research Ethics Service, South Central Oxford B Research Ethics Committee (ref: 18/SC/0071). The study results will inform whether to progress to a full-scale RCT to test the efficacy of offering this programme for patients with type 2 diabetes in primary care.</p><p> TRIAL REGISTRATION NUMBER: ISRCTN registry (ISRCTN 62452621)</p> |
| spellingShingle | Morris, E Aveyard, P Dyson, P Noreik, M Bailey, C Fox, R Hoffman, K Tan, G Jebb, S Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND): protocol for a randomised feasibility trial |
| title | Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND): protocol for a randomised feasibility trial |
| title_full | Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND): protocol for a randomised feasibility trial |
| title_fullStr | Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND): protocol for a randomised feasibility trial |
| title_full_unstemmed | Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND): protocol for a randomised feasibility trial |
| title_short | Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND): protocol for a randomised feasibility trial |
| title_sort | dietary approaches to the management of type 2 diabetes diamond protocol for a randomised feasibility trial |
| work_keys_str_mv | AT morrise dietaryapproachestothemanagementoftype2diabetesdiamondprotocolforarandomisedfeasibilitytrial AT aveyardp dietaryapproachestothemanagementoftype2diabetesdiamondprotocolforarandomisedfeasibilitytrial AT dysonp dietaryapproachestothemanagementoftype2diabetesdiamondprotocolforarandomisedfeasibilitytrial AT noreikm dietaryapproachestothemanagementoftype2diabetesdiamondprotocolforarandomisedfeasibilitytrial AT baileyc dietaryapproachestothemanagementoftype2diabetesdiamondprotocolforarandomisedfeasibilitytrial AT foxr dietaryapproachestothemanagementoftype2diabetesdiamondprotocolforarandomisedfeasibilitytrial AT hoffmank dietaryapproachestothemanagementoftype2diabetesdiamondprotocolforarandomisedfeasibilitytrial AT tang dietaryapproachestothemanagementoftype2diabetesdiamondprotocolforarandomisedfeasibilitytrial AT jebbs dietaryapproachestothemanagementoftype2diabetesdiamondprotocolforarandomisedfeasibilitytrial |