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| Name | Class |
|---|---|
| University of Canberra | OTHER |
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The aim of this study is to examine the association between a low carbohydrate diet, quality of life and glycaemic control in Australian adults with T1DM. The first phase of the study will develop and validate a diabetes specific quality of life questionnaire for adults with T1DM. The second phase will undertake a low carbohydrate diet intervention and examine its association with quality of life and glycaemic control, pre and post the dietary intervention. The novel outcomes will include a new validated Australian T1DM specific quality of life questionnaire and an investigation as to whether a low carbohydrate diet mediates the relationship between quality of life and glycaemic control in Australian adults with T1DM.
Phase 1:
Aim: To develop a reliable and valid diabetes specific quality of life questionnaire for use in Australian adults living with type 1 diabetes mellitus (T1DM).
Objectives:
Phase 2:
Aim: The aim of this study is to examine the association between a low carbohydrate diet, quality of life and glycaemic control in adults living with T1DM.
Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low carbohydrate dietary group | Participants n = 23 Participants:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low carbohydrate diet | Other | Study duration: 13 weeks (run in phase = 1 week; low carbohydrate diet phase = 12 weeks). Each participant will be provided with an individualised meal plans to meet their energy needs as per the Schofield formula and a macronutrient distribution of 20% for carbohydrate, 25% for protein and 55% for fat. Participants will self-report quality of life using a validated diabetes specific quality of life questionnaire for Australian adults and HbA1c (pre and post intervention phase of 13 weeks duration) . |
| Measure | Description | Time Frame |
|---|---|---|
| Self reported quality of life at baseline pre intervention | Baseline (pre intervention) participant self reported quality of life using the newly validated Australian diabetes specific quality of life questionnaire which uses a Likert scale of 1 = very strongly disagree to 10 = very strongly agree, from baseline to 12 weeks after intervention | Baseline (pre intervention) |
| Self reported quality of life at 12 weeks post intervention | % change in participant self reported quality of life from baseline to 12 weeks (post intervention) using the newly validated Australian diabetes specific quality of life questionnaire which uses a Likert scale of 1 = very strongly disagree to 10 = very strongly agree, from baseline to 12 weeks after intervention | 12 weeks (post intervention) |
| Glycaemic control (HbA1c) at baseline pre intervention | Baseline (pre intervention) in glycaemic control (HbA1c) | Baseline (pre intervention) |
| Glycaemic control (HbA1c) | % change in glycaemic control from baseline to 12 weeks (post intervention) (HbA1c) | 12 weeks (pre and post intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janine Paul, MSc | Gold Coast Hospital and Health Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gold Coast Hospital and Health Service | Gold Coast | Queensland | 4215 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33769300 | Derived | Paul J, Jani R, Davoren P, Knight-Agarwal C. Association Between a Low Carbohydrate Diet, Quality of Life, and Glycemic Control in Australian Adults Living With Type 1 Diabetes: Protocol for a Mixed Methods Pilot Study. JMIR Res Protoc. 2021 Mar 26;10(3):e25085. doi: 10.2196/25085. |
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The data collected in this study is specific to this doctoral research project. Therefore, there will be no data sharing with any other researchers who are not members of this study. Where a current research team member wishes to use any of this data research purposes, the research must be approved by an Ethics committee, involve the PI who will ultimately retain oversight of all future uses of data and will remain the ongoing custody of data and/or research outputs.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |